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1
Home Access HIV-1 Test System

... Premarket Approvals with Supporting Documents. -. Home Access HIV-1 Test System. ... Product Information. Label - Home Access HIV-1 Test System (PDF - 2243KB). -. -. ...

Center for Biologics Evaluation and Research (CBER)

2
Recall of Home Access and Home Access Express HIV-1 Test ...

... Recall of Home Access and Home Access Express HIV-1 Test System-Home Access Health Corporation. DATE RECALL INITIATED: ...

Center for Biologics Evaluation and Research (CBER)

3
Home Access HIV-1 Test System, Home Access Health Corp.

... Throughout the education session, clients have the option of speaking with an HAHC ... was conducted in the general population, the other in a high-risk population ...

Center for Biologics Evaluation and Research (CBER)

4
Home Access HIV-1 Test System, Home Access Health Corp.

... of their lifestyles and/or financial situations, this ... their results, the demographic and risk profile of ... kits over-the-counter outweigh the potential risks. ...

Center for Biologics Evaluation and Research (CBER)

5
Letter - Home Access HIV-1 Test System

... Food and Drug Administration, 9200 Corporate Blvd., Rockville, Maryland 20850 within 10 days after the applicant receives or has knowledge of information ...

Center for Biologics Evaluation and Research (CBER)

6
Roche Amplicor HIV-1 Monitor Test

... Roche Amplicor HIV-1 Monitor Test. ... Product Information. Label - Roche Amplicor HIV-1 Monitor Test (PDF - 3536KB). -. -. Supporting Documents. ...

Center for Biologics Evaluation and Research (CBER)

7
HIV-1/2

... Screening; Infectious Disease Tests. -. HIV-1/2. -. Human Immunodeficiency Virus Types 1 & 2 (Anti-HIV-1/2 Assay). Abbott ...

Center for Biologics Evaluation and Research (CBER)

8
Multispot HIV-1/HIV-2 Rapid Test

Page 1. Multispot HIV-1/HIV-2 Rapid Test ... For In Vitro Diagnostic Use 25228 50 Tests Page 2. Multispot HIV-1/HIV-2 Rapid Test 2 CONTENTS ...

Center for Biologics Evaluation and Research (CBER)

9
COBAS AmpliScreen HIV-1 Test

... COBAS AmpliScreen HIV-1 Test. ... Product Information. HIV - Nucleic Acid Test - COBAS Ampliscreen HIV-1 Test - Package Insert (PDF - 547KB). -. -. Supporting Documents ...

Center for Biologics Evaluation and Research (CBER)

10
HIV-1 and Hepatitis B Transmission in Sudan

... Accession Number : ADA219364. Title : HIV-1 and Hepatitis B Transmission in Sudan. Descriptive Note : Journal article. ...

DTIC Science & Technology

11
Use of Recombigen HIV-1 LA Test

Page 1. Use of the Recombigen HIV-1 LA Test (2/1/89) ... Subject: Use of the Recombigen HIV-1 LA Test To: All Register Blood and Plasma Establishment ...

Center for Biologics Evaluation and Research (CBER)

12
OraQuick ADVANCE Rapid HIV-1/2 Antibody Test

... OraQuick ADVANCE Rapid HIV-1/2 Antibody Test. Proper Name: OraQuick ADVANCE Rapid HIV-1/2 Antibody Test Tradename ...

Center for Biologics Evaluation and Research (CBER)

13
Medical Device Notification: HIV-1/HIV-2 Plus O EIA Testing ...

... Medical Device Notification: HIV-1/HIV-2 Plus O EIA Testing Software-DiaSporin, Inc. ... PRODUCT: HIV-1 / HIV-2 Plus O EIA Testing Software. ...

Center for Biologics Evaluation and Research (CBER)

14
MedMira Reveal Rapid HIV-1 Antibody Test

... Premarket Approvals with Supporting Documents. -. MedMira Reveal Rapid HIV-1 Antibody Test. ... Label - MedMira Reveal Rapid HIV-1 Antibody Test (PDF - 192KB). -. -. ...

Center for Biologics Evaluation and Research (CBER)

15
Package Insert - MedMira Reveal Rapid HIV-1 Antibody Test ...

Page 1. 1 Reveal� Rapid HIV-1 Antibody Test This package insert must be read carefully and completely prior to use of ...

Center for Biologics Evaluation and Research (CBER)

16
INSTI� HIV-1 Antibody Test

... November 29, 2010 Approval Letter - INSTI HIV-1 Antibody Test Kit Indicated for the detection of antibodies to Human Immunodeficiency Virus Type ...

Center for Biologics Evaluation and Research (CBER)

17
Hiv-1 / HCV Assay, Procleix

Page 1. Procleix ® HIV-1/HCV Assay For In Vitro Diagnostic Use 1000 Test Kit, 5000 Test Kit CONTENTS ...

Center for Biologics Evaluation and Research (CBER)

18
HIV-1 Assay, COBAS AmpliScreen HIV-1 Test

... COBAS AmpliScreen� HIV-1 Test, v.1.5 ... binding regions identical to those of the HIV-1 target sequence ... unique probe binding region that differentiates the HIV-1 ...

Center for Biologics Evaluation and Research (CBER)

19
Morbidity and Mortality Among a Cohort of Human Immunodeficiency Virus Type 1-Infected and Uninfected Pregnant Women and Their Infants From Malawi, Zambia, and Tanzania
2008-09-01

Background:Morbidity and mortality patterns among pregnant women and their infants (before antiretroviral therapy was widely available) determines HIV-1 diagnostic, monitoring, and care interventions.Methods:Data from mothers and their infants enrolled in a trial of antibiotics to reduce mother-to-child-transmission of HIV-1 at 4 sub-Saharan African sites ...

PubMed Central

20
Protease inhibitors work against HIV-1 subtype C.
1999-05-01

Stanford University researchers have determined that protease inhibitors are effective against HIV-1 subtype C infections. HIV-1 subtype C, while common in Africa and India, is not prevalent in the United States, and the drugs previously had not been tested for their effectiveness against that ...

PubMed

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21
Early HIV-1 diagnosis using in-house real time PCR amplification on dried blood spots for infants in remote and resource limited settings
2008-12-15

BackgroundIn resource-limited settings, most perinatally HIV-1-infected infants do not receive timely antiretroviral therapy because early HIV-1 diagnosis is not available or affordable.ObjectiveTo assess the performance of a low cost in-house real-time PCR assay to detect ...

PubMed Central

22
HIV-1

... Inc; OraSure HIV-1 Western Blot Kit Epitope, Inc; MedMira Reveal Rapid HIV-1 Antibody Test MedMira Laboratories, Inc; Trinity Biotech ...

Center for Biologics Evaluation and Research (CBER)

23
INSTI� HIV-1Antibody Test Package Insert

... 2 (HIV-2). HIV-1 and HIV-2 are similar in genomic structure, morphology and ... are prevalent in blood or blood products from persons at high risk of ...

Center for Biologics Evaluation and Research (CBER)

24
Cambridge Biotech HIV-1 Western Blot Kit

... Blood & Blood Products; Approved Products; Licensed Products (BLAs); Blood Donor Screening; Infectious Disease Tests. -. Cambridge Biotech HIV-1 Western Blot Kit ...

Center for Biologics Evaluation and Research (CBER)

25
Genetic diversity among human immunodeficiency virus-1 non-B subtypes in viral load and drug resistance assays.
2010-10-01

The tremendous diversity of human immunodeficiency virus (HIV)-1 strains circulating worldwide has an important impact on almost all aspects of the management of this infection, from the identification of infected persons, through treatment efficacy and monitoring, and prevention strategies such as vaccine design. The areas where ...

PubMed

26
Evaluation of the diagnostic performance of the rapid test VIKIA HIV1/2 in a highly complex HIV-1 epidemic.
2011-07-27

The rapid test VIKIA HIV1/2 was evaluated in 210 Angolan subjects infected with multiple HIV-1 subtypes and complex recombinant forms and 225 seronegative individuals. All infected subjects tested positive (100% sensitivity); all seronegative subjects ...

PubMed

27
Development of an RNA Assay to Access HIV-1 Latency.
1991-04-19

... The previous study was successful in the development of a sensitive, quantitative assay for HIV-1 DNS sequences. The ...

DTIC Science & Technology

28
JSTOR

Page 1. Procleix � HIV-1/HCV Assay For In Vitro Diagnostic Use 1000 Test Kit, 5000 Test Kit CONTENTS ...

Center for Biologics Evaluation and Research (CBER)

29
Performance Characteristics of Human Immunodeficiency Virus Type 1 (HIV-1) Genotyping Systems in Sequence-Based Analysis of Subtypes Other than HIV-1 Subtype B
2003-03-01

Given the diversity of human immunodeficiency virus type 1 (HIV-1) subtypes and the emergence of subtypes other than HIV-1 subtype B in the United States, genotypic assays must be capable of delivering sequence data on diverse HIV-1 subtypes. We evaluated the performance of ...

PubMed Central

30
Subject Information Notice: Multispot HIV-1/HIV-2 Rapid Test

Page 1. Multispot HIV-1/HIV-2 Rapid Test Subject Information Notice It is very important for you to read this brochure before you are tested for HIV. ...

Center for Biologics Evaluation and Research (CBER)

31
INSTI� HIV-1 Antibody Test - Summary of Safety and ...

... blue spot whereas most other rapid tests use colloidal gold, producing red ... and specificity of the INSTI� HIV-1 Antibody Test, 195 serum/plasma ...

Center for Biologics Evaluation and Research (CBER)

32
HIV-1 viral diversity and its implications for viral load testing: review of current platforms.
2011-07-20

The 2008 Recommendations for care of the International AIDS Society reaffirmed the importance of both accurate and sensitive viral load assessment, and by necessity, access to viral load assays. HIV-1 viral load testing is considered essential when initiating antiretroviral therapy (ART), when monitoring ART ...

PubMed

33
Development of an RNA Assay to Access HIV-1 Latency.
1991-04-19

... AD_____ DEVELOPMENT OF AN RNA ASSAY TO ACCESS HIV-I LATENCY ... Development of an RNA Assay to Assess HIV-I Latency ...

DTIC Science & Technology

34
Urgent Medical Device Removal: HIV-1 MONITOR Test, v1.5

... Roche Diagnostics has confirmed that the HIV-1 MONITOR Quantitation Standard (HIM QS) vials in the COBAS AMPLICOR HIV-1 MONITOR Test, v1.5 generate low or no ...

Center for Biologics Evaluation and Research (CBER)

35
Punica granatum (Pomegranate) juice provides an HIV-1 entry inhibitor and candidate topical microbicide
2004-10-14

BackgroundFor ? 24 years the AIDS pandemic has claimed ? 30 million lives, causing ? 14,000 new HIV-1 infections daily worldwide in 2003. About 80% of infections occur by heterosexual transmission. In the absence of vaccines, topical microbicides, expected to block virus transmission, offer hope for controlling the pandemic. Antiretroviral ...

PubMed Central

36
OraQuick Rapid HIV-1 Antibody Test Questions and Answers

... What type of counseling is done for rapid HIV tests? Counseling for rapid HIV tests includes: ... Does this test detect antibodies to HIV-2? ...

Center for Biologics Evaluation and Research (CBER)

37
OraQuick Rapid HIV-1 Antibody Test

... No animal studies were performed using the OraQuick ... if tested, do not return for their test results ... Rapid HIV testing addresses this issue by providing results ...

Center for Biologics Evaluation and Research (CBER)

38
September 18, 2001 Approval Letter - UltraQual HIV-1 RT-PCR Assay

... This method may be used as an alternative to currently licensed HIV-1 p24 antigen tests for screening Source Plasma. National Genetics Institute is hereby ...

Center for Biologics Evaluation and Research (CBER)

39
Package Insert - Reveal G2 Rapid HIV-1 Antibody Test, Medmira Labs ...

... result, due to the absence of the HIV -1 antibody/antigen complex, is indicated ... Sodium azide forms lead or copper azide in laboratory plumbing and may explode ...

Center for Biologics Evaluation and Research (CBER)

40
COBAS TaqScreen MPX Test

Human Immunodeficiency Virus Type 1 (HIV-1) Group M RNA, HIV-1 Group O RNA, Human Immunodeficiency Virus Type 2 (HIV-2) RNA, Hepatitis ...

Center for Biologics Evaluation and Research (CBER)

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41
Evaluation of four rapid tests for diagnosis and differentiation of HIV-1 and HIV-2 infections in Guinea-Conakry, West Africa.
2010-06-17

With both HIV-1 and HV-2 prevalent in Guinea-Conakry, accurate diagnosis and differentiation is crucial for treatment purposes. Thus, four rapid HIV tests were evaluated for their HIV-1 and HIV-2 diagnostic and discriminative capacity for use in Guinea-Conakry. These included SD Bioline HIV 1/2 ...

PubMed

42
Use of Sequence Data Generated in the Bayer TruGene Genotyping Assay To Recognize and Characterize Non-Subtype-B Human Immunodeficiency Virus Type 1 Strains
2005-10-01

Human immunodeficiency virus type 1 (HIV-1) protease (PR) and reverse transcriptase (RT) gene sequences obtained during antiretroviral resistance testing with a commercial genotyping assay (TruGene; Bayer Corp.) were analyzed to assess the utility of these data for detecting and characterizing non-subtype-B ...

PubMed Central

43
Recent HIV type 1 infection among participants in a same-day mobile testing pilot study in Zimbabwe.
2011-01-15

We estimated HIV-1 incidence and characterized risk factors associated with recent infection among participants of a mobile HIV voluntary counseling and testing (VCT) pilot program in two communities in Zimbabwe (N = 1096). HIV-1 infection was diagnosed using a parallel rapid ...

PubMed

44
INSTI� HIV-1 Antibody Test Customer Letter Dear Customer, Thank ...

... Test contains warnings and precautions, restrictions on the sale, distribution and use ... or Non- Reactive INSTI test result, as well as general information about ...

Center for Biologics Evaluation and Research (CBER)

45
Special Anniversary Review: Twenty-five years of human immunodeficiency virus research: successes and challenges
2008-05-01

During 25 years of research since HIV-1 was first identified in Paris, there have been great advances in our understanding of the virus and of the immune system. Practical advances include the early development of diagnostic tests of infection that made blood donation safe, and since 1996, combination anti-retroviral therapy that has ...

PubMed Central

46
Performance evaluation of the COBAS/TaqMan HIV-1 v2.0 in HIV-1 positive patients with low viral load: a comparative study.
2011-03-16

HIV-1 viral load determination is a crucial step for monitoring the efficacy of highly active antiretroviral therapy (HAART) and predicts disease progression. Real-time PCR based assays are available for monitoring the viral load. They differ in sensitivity, genomic target region and dynamic range. In this study, the performance of the Roche Cobas Taqman ...

PubMed

47
Evaluation of a new third-generation ELISA for the detection of HIV infection.
2006-01-01

The purpose of this study was to assess whether the LG Anti-HIV 1/2 Plus ELISA (LG Life Sciences, Seoul, Korea), a new third-generation enzyme-linked immunosorbent assay for the detection of HIV infection, has improved sensitivity and specificity in comparison to the other licensed third-generation assays. The sensitivity of the LG ...

PubMed

48
Human Immunodeficiency Virus (HIV) types Western blot (WB) band profiles as potential surrogate markers of HIV disease progression and predictors of vertical transmission in a cohort of infected but antiretroviral therapy na�ve pregnant women in Harare, Zimbabwe
2011-01-06

BackgroundExpensive CD4 count and viral load tests have failed the intended objective of enabling access to HIV therapy in poor resource settings. It is imperative to develop simple, affordable and non-subjective disease monitoring tools to complement clinical staging efforts of inexperienced health personnel currently manning most healthcare centres ...

PubMed Central

49
Use of the Recombigen HIV-1 Latex Agglutination (LA) Test

... eligible for reentry. The prior memorandum mentioned circumstances which could give rise to false positive results. This test requires ...

Center for Biologics Evaluation and Research (CBER)

50
OraQuick Rapid HIV-1 Antibody Test product insert

... The standard laboratory HIV testing algorithm used in the United States consists of ... after 20 minutes but not more than 60 minutes after the introduction of the ...

Center for Biologics Evaluation and Research (CBER)

51
Letter - COBAS AmpliPrep/COBAS TaqMan HIV - 1 Test, 48 Tests ...

... Changes Being Effected." This procedure is not applicable to changes in device design, composition, specifications, circuitry, software or energy source. ...

Center for Biologics Evaluation and Research (CBER)

52
Laboratory Guidelines and Standards
2011-08-14

Clearinghouse bullet Quality Assurance Guidelines for Testing Using the OraQuick Rapid HIV-1 Antibody Test PDF (06/16/2003) Appendices: Government Regulations and Sample Forms...

Science.gov Websites

53
INSTI� HIV-1 Antibody Test - Subject Information Brochure

... test. If you learn that you are infected with HIV, you can take steps to avoid activities that will Page 2. pass it on to others. ...

Center for Biologics Evaluation and Research (CBER)

54
HIV-1 Antibody Test Kit Controls

... to a new lot number of INSTI� test kits � whenever a new shipment of kits is received � when temperature during storage of the kit falls outside of 15°-30 ...

Center for Biologics Evaluation and Research (CBER)

55
FDA Workshop on Testing for Malarial Infections in Blood ...

... donor interview); Laboratory testing and deferral (HIV-1, HIV-2, HBV, HCV, HTLV-I, HTLV-II, WNV, syphilis); Deferral registries ...

Center for Biologics Evaluation and Research (CBER)

56
HIV-1/AIDS and maternal and child health in Africa.
2002-06-15

Every day, 1900 children acquire HIV-1 infection from their mother in Africa. The 25-45% risk of mother-to-child transmission can be reduced in several ways: prevention of sexual transmission for women of child-bearing age, access to HIV-1 testing, reduction of unwanted pregnancies by education of HIV-1-infected ...

PubMed

57
Sensitivity of the Procleix HIV-1/HCV Assay for Detection of Human Immunodeficiency Virus Type 1 and Hepatitis C Virus RNA in a High-Risk Population
2002-07-01

The Procleix HIV-1/HCV Assay is a high-throughput nucleic acid test for the simultaneous detection of human immunodeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV) RNA during blood donor screening. This study evaluated the clinical sensitivity of the Procleix assay and assessed the ...

PubMed Central

58
Cryptic Nature of a Conserved, CD4-Inducible V3 Loop Neutralization Epitope in the Native Envelope Glycoprotein Oligomer of CCR5-Restricted, but Not CXCR4-Using, Primary Human Immunodeficiency Virus Type 1 Strains
2005-06-01

The external subunit of the human immunodeficiency virus type 1 (HIV-1) envelope glycoprotein (Env), gp120, contains conserved regions that mediate sequential interactions with two cellular receptor molecules, CD4 and a chemokine receptor, most commonly CCR5 or CXCR4. However, antibody accessibility to such regions is hindered by ...

PubMed Central

59
Characteristics, immunological response & treatment outcomes of HIV-2 compared with HIV-1 & dual infections (HIV 1/ 2) in Mumbai
2010-12-01

Background & objectives:Information available on HIV-2 and dual infection (HIV-1/2) is limited. This study was carried out among HIV positive individuals in an urban referral clinic in Khar, Mumbai, India, to report on relative proportions of HIV-1, HIV-2 and HIV-1/2 and baseline characteristics, response to and outcomes on antiretroviral treatment ...

PubMed Central

60
Inaccurate Diagnosis of HIV-1 Group M and O Is a Key Challenge for Ongoing Universal Access to Antiretroviral Treatment and HIV Prevention in Cameroon
2009-11-06

BackgroundIncreased access to HIV testing is essential in working towards universal access to HIV prevention and treatment in resource-limited countries. We here evaluated currently used HIV diagnostic tests and algorithms in Cameroon for their ability to correctly identify HIV infections.MethodsWe estimated ...

PubMed Central

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61
Candidate Microbicides Block HIV-1 Infection of Human Immature Langerhans Cells within Epithelial Tissue Explants
2000-11-20

Initial biologic events that underlie sexual transmission of HIV-1 are poorly understood. To model these events, we exposed human immature Langerhans cells (LCs) within epithelial tissue explants to two primary and two laboratory-adapted HIV-1 isolates. We detected HIV-1Ba-L infection in ...

PubMed Central

62
Impact of the COBAS AmpliPrep/COBAS AMPLICOR HIV-1 MONITOR Test, Version 1.5, on Clinical Laboratory Operations?
2007-09-18

The COBAS AmpliPrep/COBAS AMPLICOR HIV-1 MONITOR Test, version 1.5 (CAP/CA), and the COBAS AMPLICOR HIV-1 MONITOR Test, version 1.5, were compared. CAP/CA reduced and consolidated labor while modestly increasing assay throughput without increased failure rates or direct ...

PubMed Central

63
Semen parameters of a semen donor before and after infection with human immunodeficiency virus type 1: case report.
2004-09-09

Semen samples from a donor who seroconverted for human immunodeficiency virus type 1 (HIV-1) during the period that he was donating at our clinic were stored before and after infection. Semen analysis was done on all of these samples before cryopreservation. Retrospectively, both qualitative and quantitative HIV-1 ...

PubMed

64
Easy Kit Info and Http Eu Hiv Test - Untitled Letter

HIV 1-2 Rapid Test Kit, identified also as HIV Self Test Kit; Easy Kit � Home HIV Rapid Test Kit; HIV TEST YOURSELF test kit; Easy Kit � Get Negative ...

Center for Biologics Evaluation and Research (CBER)

65
Summary of Safety and Effectiveness - MedMira Reveal Rapid ...

... VIII. ... Sensitivity of the Reveal Rapid HIV-1 Antibody Test in the Detection of HIV-1 From Various Geographic Regions The sensitivity of the Reveal ...

Center for Biologics Evaluation and Research (CBER)

66
OraQuick Rapid HIV-1 Antibody Test

... November 7, 2002 Approval Letter. Package Insert (PDF - 238 KB). Summary of Safety and Effectiveness (PDF - 82 KB). -. Related Information. ...

Center for Biologics Evaluation and Research (CBER)

67
Multispot HIV-1/HIV-2 Rapid Test

... The human source material used in the preparation of ... Materials Required But Not Provided 1. Disposable glass ... that demonstrate purple color development in the ...

Center for Biologics Evaluation and Research (CBER)

68
Letter - Multispot HIV-1/HIV-2 Rapid Test

... of data from any clinical investigations or nonclinical laboratory studies involving ... Any significant chemical, physical or other change or deterioration in the ...

Center for Biologics Evaluation and Research (CBER)

69
Letter - MedMira Reveal Rapid HIV-1 Antibody Test

... Being Effected." This procedure is not applicable to changes in device design, composition, specifications, circuitry, software or energy source. ...

Center for Biologics Evaluation and Research (CBER)

70
LABORATORY OF RETROVIRUS RESEARCH Presentation

... HIV-SELECTEST: a new HIV-1 EIA and Rapid test for differential diagnosis of HIV infections in the face of vaccine-induced antibodies. S. Khurana et al. 2006. ...

Center for Biologics Evaluation and Research (CBER)

71
Indeterminate HIV-1 Western Blots: Etiology, Natural History ...
1992-09-16

... Natural History, and Psychological Reactions. ... NATURAL HISTORY, *REACTION(PSYCHOLOGY), TEST ... SEX, ACQUIRED IMMUNE DEFICIENCY ...

DTIC Science & Technology

72
Indeterminate HIV-1 Western Blots: Etiology, Natural History ...
1991-09-24

... A case-control study demonstrated past positive tuberculin skin test, recent tetanus booster, autoantibodies, and parity were associated with IWBs. ...

DTIC Science & Technology

73
Draft PTC - In Vitro Tests for Anti-HIV 1

... enzyme-linked immunosorbent assay (ELISA), Human Immunodeficiency Virus (HIV), immunofluorescence-assay (IFA), optical density (OD), radioimmunoprecipitation ...

Center for Biologics Evaluation and Research (CBER)

74
COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, 48 Tests ...

... COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, 48 Tests; COBAS AmpliPrep/COBAS TaqMan Wash Reagent, 5.1 L. Proper ...

Center for Biologics Evaluation and Research (CBER)

75
Analysis of a highly immunodominant epitope in the human immunodeficiency virus type 1 transmembrane glycoprotein, gp41, defined by a human monoclonal antibody.
1990-09-01

A human monoclonal antibody, 41-7 [immunoglobulin G1(kappa)], directed against the transmembrane glycoprotein gp41 of the human immunodeficiency virus type 1 (HIV-1) has been produced by direct fusion of lymph node cells from an HIV-1-infected individual with a human B-lymphoblastoid cell line. The minimal essential epitope for 41-7 was mapped to a ...

PubMed Central

76
Safety and anti-HIV assessments of natural vaginal cleansing products in an established topical microbicides in vitro testing algorithm
2010-07-09

BackgroundAt present, there is no effective vaccine or other approved product for the prevention of sexually transmitted human immunodeficiency virus type 1 (HIV-1) infection. It has been reported that women in resource-poor communities use vaginally applied citrus juices as topical microbicides. These easily accessible food products ...

PubMed Central

77
Plausibility of HIV-1 Infection of Oral Mucosal Epithelial Cells.
2011-04-01

The AIDS pandemic continues. Little is understood about how HIV gains access to permissive cells across mucosal surfaces, yet such knowledge is crucial to the development of successful topical anti-HIV-1 agents and mucosal vaccines. HIV-1 rapidly internalizes and integrates into the mucosal ...

PubMed

78
Performance characteristics of human immunodeficiency virus type 1 (HIV-1) genotyping systems in sequence-based analysis of subtypes other than HIV-1 subtype B.
2003-03-01

Given the diversity of human immunodeficiency virus type 1 (HIV-1) subtypes and the emergence of subtypes other than HIV-1 subtype B in the United States, genotypic assays must be capable of delivering sequence data on diverse HIV-1 subtypes. We evaluated the performance of ...

PubMed

79
Efficient monitoring of HIV-1 vertically infected children in Kenya on first-line antiretroviral therapy.
2011-07-26

BACKGROUND: Worldwide access to antiretroviral therapy (ART) in low- and middle-income countries has significantly increased. Although this presents better treatment options for HIV-infected individuals, the challenge of monitoring ART in these settings still remains. OBJECTIVE: To investigate efficient and cost-effective criteria for assessing ART failure among ...

PubMed

80
Correlation between human immunodeficiency virus type 1 (HIV-1) RNA measurements obtained with dried blood spots and those obtained with plasma by use of Nuclisens EasyQ HIV-1 and Abbott RealTime HIV load tests.
2009-02-04

The plasma human immunodeficiency virus (HIV) RNA load is used in the clinical routine for the monitoring of HIV infection and the patient's response to antiretroviral therapy. Other body fluids or dried blood spots (DBS) can be used, however, to assess the level of viremia. The use of DBS may be especially helpful for the monitoring of HIV-infected patients in resource-poor settings, where ...

PubMed

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81
HIV-1 prevalence and factors associated with infection in the conflict-affected region of North Uganda
2007-03-01

BackgroundSince 1986, northern Uganda has been severely affected by civil strife with most of its population currently living internally displaced in protected camps. This study aims at estimating the HIV-1 prevalence among this population and the factors associated with infection.MethodsIn June-December 2005, a total of 3051 antenatal clinics attendees in Gulu, Kitgum and Pader districts were ...

PubMed Central

82
Risk Factors for Late Postnatal Transmission of Human Immunodeficiency Virus Type 1 in Sub-Saharan Africa
2008-03-01

BackgroundWe conducted secondary data analyses of a clinical trial (HIVNET 024) to assess risk factors for late postnatal transmission (LPT) of HIV-1 through breastfeeding.MethodsData regarding live born, singleton infants of HIV-1-infected mothers were analyzed. The timing of HIV-1 transmission through 12 months after birth was defined as: in utero (positive ...

PubMed Central

83
Deactivation of human immunodeficiency virus type 1 in medium by copper oxide-containing filters.
2007-12-10

Human immunodeficiency virus type 1 (HIV-1) can be transmitted through breast-feeding and through contaminated blood donations. Copper has potent biocidal properties and has been found to inactivate HIV-1 infectivity. The objective of this study was to determine the capacity of copper-based filters to inactivate ...

PubMed

84
Deactivation of Human Immunodeficiency Virus Type 1 in Medium by Copper Oxide-Containing Filters?
2008-02-10

Human immunodeficiency virus type 1 (HIV-1) can be transmitted through breast-feeding and through contaminated blood donations. Copper has potent biocidal properties and has been found to inactivate HIV-1 infectivity. The objective of this study was to determine the capacity of copper-based filters to inactivate ...

PubMed Central

85
Ridostin inhibits HIV-1 replication in the T lymphoblastoid cell line C8166. Possible role of altered cytokine production.
1995-09-01

Altered cytokine production in human immunodeficiency virus 1 (HIV-1) infection is well documented and cytokine modulators are currently under investigation as possible therapeutic agents. We tested the ability of Ridostin (dsRNA preparation derived from S. cervisiae) to inhibit HIV-1 ...

PubMed

86
Dendritic cells infected by recombinant rabies virus vaccine vector expressing HIV-1 Gag are immunogenic even in the presence of vector-specific immunity.
2010-08-20

Dendritic cells (DC) are the most potent antigen presenting cells whose ability to interact with T cells, B cells and NK cells has led to their extensive use in vaccine design. Here, we designed a DC-based HIV-1 vaccine using an attenuated rabies virus vector expressing HIV-1 Gag (RIDC-Gag). To ...

PubMed

87
Sexually Transmitted Infections among HIV-1-Discordant Couples
2009-12-14

IntroductionMore new HIV-1 infections occur within stable HIV-1-discordant couples than in any other group in Africa, and sexually transmitted infections (STIs) may increase transmission risk among discordant couples, accounting for a large proportion of new HIV-1 ...

PubMed Central

88
Development of candidate reference reagent for HIV-1 RNA and comparison analysis for different HIV-1 RNA quantitative assay.
2011-06-10

Abstract Background: Human immunodeficiency virus type-1 (HIV-1) RNA viral load is a surrogate marker that is routinely used to determine indications for, and monitor the effectiveness of HIV-1 treatment. We developed three reagents for potential use in routine quality control of HIV-1 RNA quantitative assays. In this report, we compare the stability of ...

PubMed

89
Evaluation of the Roche COBAS� TaqMan� HIV-1 test for quantifying HIV-1 RNA in infected cells and lymphoid tissue.
2011-03-31

Lymphoid tissue is the main reservoir of HIV-1 in infected individuals. In this study the COBAS� TaqMan� HIV-1 test was evaluated for use with the High Pure System (HPS), for quantifying HIV-1 RNA in infected cells and lymphoid tissue specimens. Serial dilutions of 8E5-LAV1 infected T-cells ...

PubMed

90
Heterosexual HIV-1 transmission after initiation of antiretroviral therapy: a prospective cohort analysis
2010-05-26

BackgroundHigh plasma HIV-1 RNA concentrations are associated with increased risk of HIV-1 transmission. Initiation of antiretroviral therapy (ART) reduces plasma HIV-1 concentrations, but little empiric data are available on the rate of sexual HIV-1 transmission from ...

PubMed Central

91
SURE CHECK HIV 1/2 ASSAY Chembio HIV Reactive/Nonreactive Controls

... for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and HIV-2. This test is suitable for use in multi-test algorithms designed for ...

Center for Biologics Evaluation and Research (CBER)

92
RNA versus DNA (NucliSENS EasyQ HIV-1 v1.2 versus Amplicor HIV-1 DNA Test v1.5) for Early Diagnosis of HIV-1 Infection in Infants in Senegal.
2011-05-04

The objective of this study was to compare the performance of the NucliSENS EasyQ HIV-1 v1.2 platform (bioM�rieux, France) to the Amplicor HIV-1 DNA test v1.5 (Roche Molecular Systems, Switzerland) in detecting HIV-1 infection in infants using ...

PubMed

93
Lactoferrin Prevents Dendritic Cell-Mediated Human Immunodeficiency Virus Type 1 Transmission by Blocking the DC-SIGN-gp120 Interaction
2005-03-01

One of the cell types first encountered by human immunodeficiency virus type 1 (HIV-1) following sexual transmission are dendritic cells (DC). DC capture HIV-1 through C-type lectin receptors, of which the best studied example is DC-SIGN, which mediates HIV-1 ...

PubMed Central

94
Differentiation between human immunodeficiency virus type 1 (HIV-1) and HIV-2 isolates by nonradioisotopic reverse transcriptase-typing assay.
1994-08-01

We tested whether human immunodeficiency virus type 1 (HIV-1) could be differentiated from HIV-2 by a reverse transcriptase (RT)-typing assay that measured the reduction of enzyme activity owing to specific antibody. RT-inhibiting antibody was examined for HIV type specificity by a new nonradioisotopic RT assay. Antibodies from four ...

PubMed Central

95
COBAS AmpliScreen HIV-1 Test, version 1.5

... 8 x 0.1 mL (HIV-1 Manganese Solution, version 1.5) < 2% Manganese Acetic acid ... S: 53-45 Avoid exposure � obtain special instructions before use. ...

Center for Biologics Evaluation and Research (CBER)

96
Evaluation of a single round polymerase chain reaction assay using dried blood spots for diagnosis of HIV-1 infection in infants in an African setting
2011-02-18

BackgroundThe aim of this study was to develop an economical 'in-house' single round polymerase chain reaction (PCR) assay using filter paper-dried blood spots (FP-DBS) for early infant HIV-1 diagnosis and to evaluate its performance in an African setting.MethodsAn 'in-house' single round PCR assay that targets conserved regions in the HIV-1 polymerase ...

PubMed Central

97
COBAS AmpliScreen HIV-1 Test, version 1.5

... This mix ture can produce a highly toxic gas. ... Positive Primary pools are traced to the positive individual using an overlapping pool testing matrix. ...

Center for Biologics Evaluation and Research (CBER)

98
COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, 48 Tests COBAS AmpliPrep ...

... in which high rates of virus production and infection ... dye due to Förster-type energy transfer effects ... 0.5% sodium hypochlorite in deionized or distilled water. ...

Center for Biologics Evaluation and Research (CBER)

99
BP050069: COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, 48 Tests; COBAS ...

... Austria Indonesia Philippines Belarus Ireland Poland Belgium Israel Qatar Canada Japan Russia Chile Korea Saudi Arabia Cyprus Kuwait Slovenia ...

Center for Biologics Evaluation and Research (CBER)

100
BP050069: COBAS AmpliPrep/COBAS TaqMan HIV-1 Test ...

... acid amplification test for the quantitation of HIV-l RNA in ... T-Cell Lymphotropic viruss type 1 Human T-Cell Lymphotropic viruss ... 500 cells/uL) and ...

Center for Biologics Evaluation and Research (CBER)

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101
BP050010/0, HIV 1/2 STAT-PAK� ASSAY Chembio Diagnostic Systems ...

... Capture antigens may be peptides, proteins, fusion peptides or viral lysates. ... Rapid tests may also be used as part of a diagnostic testing algorithm. ...

Center for Biologics Evaluation and Research (CBER)

102
BP010047 / 16 - OraQuick Rapid HIV-1/2 Antibody Test - Summary of ...

... visually rather than with an instrument, 2) the OraQuick ® ADVANCE test uses colloidal gold as the ... 0 1 Interfering Substances (n = 199) Elevated Bilirubin ...

Center for Biologics Evaluation and Research (CBER)

103
510k Summary - TRUGENE HIV-1 Genotyping Kit & Open Gene DNA ...

... 1 Genotyping Kit and OpenGene DNA sequencing system. ... CB Test Certificate, Certificate Number CA 1622 / Test ... armonic Current emissions (Input current < 16 Amps ...

Center for Biologics Evaluation and Research (CBER)

104
28 CFR 549.12 - Testing.
2011-07-01

... (a) Human Immunodeficiency Virus (HIV) �(1) Clinically indicated...guidelines, that the inmate is at risk for HIV infection. If the inmate refuses testing...that the inmate may have transmitted the HIV infection, whether intentionally...

Code of Federal Regulations, 2011

105
28 CFR 549.12 - Testing.
2010-07-01

... (a) Human Immunodeficiency Virus (HIV) �(1) Clinically indicated...guidelines, that the inmate is at risk for HIV infection. If the inmate refuses testing...that the inmate may have transmitted the HIV infection, whether intentionally...

Code of Federal Regulations, 2010

106
The performance of the VIKIA(�) HIV1/2 rapid test-evaluation of the reliability and sensitivity.
2011-03-16

The use of rapid human immunodeficiency virus (HIV) antibody tests can help reduce the number of individuals positive for HIV who are unaware of their infection. Although several studies have demonstrated that the sensitivity and specificity of rapid HIV tests are comparable to those of enzyme immunoassays, none have addressed the rapidity with which these ...

PubMed

107
Multicenter Evaluation of the Performance Characteristics of the NucliSens HIV-1 QT Assay Used for Quantitation of Human Immunodeficiency Virus Type 1 RNA
2003-01-01

The analytical performance of the NucliSens HIV-1 QT assay, a highly sensitive test based on nucleic acid sequence-based amplification technology, was evaluated in a multicenter trial. Assay specificity was evaluated with 502 plasma (EDTA) specimens from human immunodeficiency virus type 1 ...

PubMed Central

108
Targets of Small Interfering RNA Restriction during Human Immunodeficiency Virus Type 1 Replication?
2008-03-16

Small interfering RNAs (siRNAs) have been shown to effectively inhibit human immunodeficiency virus type 1 (HIV-1) replication in vitro. The mechanism(s) for this inhibition is poorly understood, as siRNAs may interact with multiple HIV-1 RNA species during different steps of the retroviral life cycle. To define ...

PubMed Central

109
The measurement of HIV-1 viral load in resource-limited settings: how and where?
2007-01-01

There is an urgent need for low-cost, simple, and accurate human immunodeficiency virus type 1 (HIV-1) viral load monitoring technologies in resource-limited settings, particularly at the time of the scaling-up of first and second-line highly active antiretroviral therapies. This review describes the main characteristics and advantages/ disadvantages of ...

PubMed

110
Metabolite profiles of human immunodeficiency virus infected CD4+ T cells and macrophages using LC-MS/MS analysis.
2011-05-11

Human immunodeficiency virus type 1 (HIV-1) infects both activated CD4+ T cells and macrophages. We tested if liquid chromatography-tandem mass spectrometry (LC-MS/MS) technology can monitor metabolic alterations induced by HIV-1 in the infected cells. Here we monitored glucose uptake and conducted LC-MS/MS-based metabolomic analysis ...

PubMed

111
Syndecan-Fc Hybrid Molecule as a Potent In Vitro Microbicidal Anti-HIV-1 Agent?
2010-07-03

In the absence of a vaccine, there is an urgent need for the development of safe and effective topical microbicides to prevent the sexual transmission of human immunodeficiency virus type 1 (HIV-1). In this study, we proposed to develop a novel class of microbicides using syndecan as the antiviral agent. Specifically, we generated a soluble syndecan-Fc ...

PubMed Central

112
HIV-1 seroconversion promotes rapid changes in cervical human papillomavirus (HPV) prevalence and HPV-16 antibodies in female sex workers.
2009-02-01

The extent to which human immunodeficiency virus (HIV-1) infection impacts on the ability to mount an effective immune response to HPV is unknown, but is relevant in planning HPV vaccine strategies for HIV-1 infected individuals. This longitudinal study investigated changes shortly after HIV-1 seroconversion on ...

PubMed

113
Evaluation of the QIAsymphony� SP and Artus� RealTime extraction-quantification systems for measuring HIV-1 virus load.
2011-09-22

BACKGROUND: Automated HIV-1 RNA extraction and its quantification by real-time PCR assays provide improved sample processing and better analytical performances. The new Artus HIV-1 RealTime assay can be performed after automated extraction with the Qiagen Qiasymphony robot. OBJECTIVES AND STUDY DESIGN: To evaluate ...

PubMed

114
Bryostatin-1 synergizes with histone deacetylase inhibitors to reactivate HIV-1 from latency.
2010-09-01

The persistence of latent HIV-infected cellular reservoirs represents the major hurdle to virus eradication on patients treated with HAART. It has been suggested that successful depletion of such latent reservoirs will require a combination of therapeutic agents that can specifically and efficiently act on cells harboring latent HIV-1 provirus. Using ...

PubMed

115
NCI Funded Research Portfolio - ZIA BC 011155 Detail

This year we continued to identify novel antibodies against HIV-1 from our previously constructed and from newly constructed libraries from patients with HIV-1 infection. The major accomplishments are summarized below. 1) We have previously shown that small-size engineered antibodies can target highly conserved epitopes not accessible ...

Cancer.gov

116
Short Communication: Cataloguing the HIV Type 1 Human Protein Interaction Network
2008-12-01

AbstractAlthough many interactions between HIV-1 and human proteins have been reported in the scientific literature, no publicly accessible source for efficiently reviewing this information was available. Therefore, a project was initiated in an attempt to catalogue all published interactions between ...

PubMed Central

117
Primary HIV-1 Infection among Infants in Sub-Saharan Africa: HPTN 024
2009-07-01

ObjectiveOur objectives were to assess clinical signs and diagnoses associated with primary HIV-1 infection among infants.MethodsWe analyzed data from a clinical trial (HPTN 024) in sub-Saharan Africa. Study visits were conducted at birth, at 4�6 weeks, and at 3, 6, 9, and 12 months. The study population comprised live born, singleton, first born infants ...

PubMed Central

118
Nevirapine Resistance by Timing of HIV Type 1 Infection in Infants Treated with Single-Dose Nevirapine
2010-05-15

BackgroundIn women, single-dose nevirapine for prophylaxis against mother-to-child transmission of human immunodeficiency virus type 1 (HIV-1) selects for nevirapine-resistant HIV-1, which subsequently decays rapidly. We hypothesized that the selection, acquisition, and decay of nevirapine-resistant ...

PubMed Central

119
Survival of human immunodeficiency virus type 1 after rinsing injection syringes with different cleaning solutions.
2004-03-01

Bleaching of syringes has been advocated to prevent HIV transmission among injection drug users (IDUs). Several reports indicate that IDUs use household products to disinfect syringes instead of bleach. To test their disinfection efficacy, we performed syringe-rinsing simulations with a range of agents used by IDUs trying to disinfect their syringes. No viable ...

PubMed

120
Urgent Product Correction - Bio-Rad Laboratories Multispot ...

... Urgent Product Correction - Bio-Rad Laboratories Multispot HIV-1/HIV-2 Rapid Test - Bio-Rad Laboratories. DATE NOTIFICATION INITIATED: ...

Center for Biologics Evaluation and Research (CBER)

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121
Summary Basis for Approval - COBAS Ampliscreen HIV-1 Test

... Adenovirus type 2, Epstein Barr Virus, Human Papilloma Virus, Type 16. Adenovirus type 3, Hepatitis A Virus, Human Papilloma Virus, Type 18. ...

Center for Biologics Evaluation and Research (CBER)

122
Subject Information Notice: Multispot HIV-1/HIV-2 Rapid Test

... What should you know about HIV and AIDS? How can you become infected with HIV? ... Where can you get more information about HIV and AIDS? ...

Center for Biologics Evaluation and Research (CBER)

123
Subject Information - OraQuick ADVANCE Rapid HIV-1/2 Antibody Test ...

... An AlDS service organization near you can also be a good source for information, education, and help. ~Ddnde puedo obtener m8s informacidn? ...

Center for Biologics Evaluation and Research (CBER)

124
Subject Information - OraQuick ADVANCE Rapid HIV-1/2 Antibody Test ...

... The virus weakens the body's ability to fight off infections. As a result, people with AlDS develop serious infections and cancers. ...

Center for Biologics Evaluation and Research (CBER)

125
Recall of Amplicor HIV-1 Monitor Test, v 1.5-Roche Molecular ...

... Increased frequency of the occurrence of "blue foci" may lead to elevated and/or observed out of sequence optical density readings in the microwell plate ...

Center for Biologics Evaluation and Research (CBER)

126
Package Insert - OraQuick ADVANCE Rapid HIV-1/2 Antibody Test ...

... DO NOT allow the person to swab the roof of the mouth, the inside ... any of the following anticoagulants: EDTA (lavender top), sodium heparin (green top), sodium ...

Center for Biologics Evaluation and Research (CBER)

127
Package Insert - MedMira Reveal Rapid HIV-1 Antibody Test, MedMira ...

... 2. The United States Food and Drug Administration has ... v/v dilution of household bleach, prepared fresh daily) or ... Place the tip of the pipette into the specimen ...

Center for Biologics Evaluation and Research (CBER)

128
OraQuick Rapid HIV-1/2 Antibody Test

... March 26, 2004 Approval Letter. Control Kit (PDF - 130 KB). Subject Information (PDF - 257 KB). Approval Date: 3/19/2004. ...

Center for Biologics Evaluation and Research (CBER)

129
November 29, 2010 Approval Letter - INSTI HIV-1 Antibody Test Kit

... Before making any change affecting the safety or effectiveness of the device, you must submit a PMA supplement or an alternate submission (30-day notice) in ...

Center for Biologics Evaluation and Research (CBER)

130
Letter - OraQuick ADVANCE Rapid HIV-1/2 Antibody Test

... OraSure Technologies will provide the FDA/CBER with Western Blot results for ... Hira L. Nakhasi, Ph.D. Director Division of Emerging and Transfusion Transmitted ...

Center for Biologics Evaluation and Research (CBER)

131
Letter - MedMira Reveal G2 Rapid HIV-1 Antibody Test

... Mr. Hermes Chan MedMira Labs 155 Chain Lake Drive, Bayers Lake Halifax, Nova ... Hira L. Nakhasi, Ph.D. Director Division of Emerging and Transfusion Transmitted ...

Center for Biologics Evaluation and Research (CBER)

132
Guidance for Industry - Recommendations for Management of Donors ...

... a waiting period of one year and may be reentered if a current donation from the donor is found to be non-reactive using a group O sensitive anti-HIV-1/2 test. ...

Center for Biologics Evaluation and Research (CBER)

133
EZ-Trust� Rapid Anti-HIV (1&2) Test - Untitled Letter

... with the Act. If you have any questions regarding this matter, you may contact Anna M. Flynn at (301) 827-6201. Please be advised ...

Center for Biologics Evaluation and Research (CBER)

134
Control Kit - OraQuick ADVANCE Rapid HIV-1/2 Antibody Test ...

... MATERIALS REQUIRED BUT NOT PROVIDED Timer or watch capable of timing 20 to 40 minutes Latex, vinyl or nitrile disposable gloves Biohazard waste container Clean ...

Center for Biologics Evaluation and Research (CBER)

135
BP050010/0, HIV 1/2 STAT-PAK� ASSAY Chembio ...

... of the virus in patients causes the immune system to elicit the production of antibodies. ... in the TEST (T) area producing a pink/purple line. ...

Center for Biologics Evaluation and Research (CBER)

136
Assessment of Serological Assays for the Diagnosis of HIV-1 Infections. (Reannouncement with New Availability Information).
1991-01-01

Many serologic techniques are available for the detection of HIV-1 infection, but their diagnostic performances have been reported to vary depending on the testing situations. We evaluated eight different serologic assays for detecting HIV-1 antibody in s...

National Technical Information Service (NTIS)

137
9/17/2007 1

1 (HIV-1). Both are examples where selection has favored diversity. Its action is restricted. A splice variant of it is highly expressed in human testes and in ejaculated spermatozoa (HUANG et al. 2004

E-print Network

138
2004 Biological Device Application Supplement Approvals

... OraQuick Rapid HIV-1/2 Antibody Test, Addition to the intended use statement to include detection of antibodies to HIV-2, OraSure Technologies 150 Webster Street ...

Center for Biologics Evaluation and Research (CBER)

139
2002 Biological Device Application Approvals

... HIV-1 Genotyping Kit & Open Gene DNA Sequencing System, HIV test kit used in the detection of genomic mutations, BK020005, Visible Genetics, Inc 700 Bay Street ...

Center for Biologics Evaluation and Research (CBER)

140
Stability of human immunodeficiency virus type 1 RNA in cerebrospinal fluid determined with the AMPLICOR HIV-1 MONITOR test, version 1.5 (ultrasensitive).
2002-10-01

We evaluated the effects of time, temperature, freezing, and thawing on the cerebrospinal fluid viral load by using the Roche AMPLICOR HIV-1 MONITOR test, version 1.5 (ultrasensitive). While a statistically significant decrease from the baseline was observed at 24 h, but not at 6 or 12 h, and with one freeze-thaw cycle, all changes ...

PubMed

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141
Stability of Human Immunodeficiency Virus Type 1 RNA in Cerebrospinal Fluid Determined with the AMPLICOR HIV-1 MONITOR Test, Version 1.5 (Ultrasensitive)
2002-10-01

We evaluated the effects of time, temperature, freezing, and thawing on the cerebrospinal fluid viral load by using the Roche AMPLICOR HIV-1 MONITOR test, version 1.5 (ultrasensitive). While a statistically significant decrease from the baseline was observed at 24 h, but not at 6 or 12 h, and with one freeze-thaw cycle, all changes ...

PubMed Central

142
Performance of a Rapid and Simple HIV Testing Algorithm in a Multicenter Phase III Microbicide Clinical Trial.
2011-07-13

A multi-test sequential algorithm based on Rapid/Simple (R/S) assays was applied for the diagnosis of HIV infection among participants in a phase 3 microbicide effectiveness trial. HIV testing was performed on finger-prick blood samples from patients after their enrollment in the trial. The specimens were tested in a serial procedure ...

PubMed

143
[Comparative analysis of ViroSeq and Trugene HIV-1 genotyping systems in the application to the virus variants in Russia].
2009-12-01

The ViroSeq (Celera Diagnostics) and Trugene (Bayer HealthCare) HIV-1 genotyping systems are widely used today in world clinical practice to detect drug resistance mutations resulting from ineffective treatment for HIV infection. Only the former test has gained acceptance. The present study has compared ViroSeq and Trugene genotyping ...

PubMed

144
Coinfection with tuberculosis and HIV-1 in male prison inmates.

An association between past exposure to tuberculosis (TB) and infection with human immunodeficiency virus type 1 (HIV-1) was investigated using a case-control design among a 6-week sample of 698 male inmates consecutively admitted to the Maryland State prison system. Based on Mantoux testing and measurement of anti-HIV-1, we found a ...

PubMed

145
Synthesis of Quinolin-2-one Alkaloid Derivatives and Their Inhibitory Activities against HIV-1 Reverse Transcriptase.
2011-09-07

Based on an established common pharmacophore of HIV-1 non-nucleoside reverse transcriptase inhibitors (NNTTIs), a series of quinolin-2-one derivatives were synthesized and assayed for their in vitro activities against HIV-1 reverse transcriptase (RT) for the first time. Some of the tested compounds were active against ...

PubMed

146
Subjective complaints versus actual cognitive deficits in predominantly symptomatic HIV-1 seropositive individuals.
1997-01-01

The relationship of self-reported cognitive, motor, and affective complaints to actual neuropsychological functioning was explored in a cohort of predominantly symptomatic HIV-1 seropositive individuals. Ninety-two symptomatic HIV-1 infected subjects were questioned about complaints common in HIV infection and were ...

PubMed

147
Pre-clinical and clinical development of a multi-envelope, DNA-Virus-Protein (D-V-P) HIV-1 vaccine
2009-01-01

The human immune system has evolved to recognize antigenic diversity, a strength that has been harnessed by vaccine developers to combat numerous pathogens (e.g. pneumococcus, influenza virus, rotavirus). In each case, vaccine cocktails were formulated to include antigenic variants of the target. To combat HIV-1 diversity, we assembled a cocktail vaccine ...

PubMed Central

148
Lack of alternative coreceptor use by pediatric HIV-1 R5 isolates for infection of primary cord or adult peripheral blood mononuclear cells.
2007-12-13

HIV-1 infection of neonates results in an extended acute period of virus replication, frequent neurological problems and reduced survival compared to adults. In adults, R5 viruses mainly infect CCR5(+) CD4(+) memory T-cells. In neonates, CCR5(+) memory T-cells form a substantially smaller fraction of total lymphocytes. We therefore ...

PubMed

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