Clinical trials: HIV Testing
HIV Infection
Safety and Efficacy Study of AGS-004 During Analytical Treatment Interruption
The purpose of this study is to determine the safety and effectiveness of AGS-004, an immune therapy, for HIV-infected individuals.
- Trial name
- NCT01069809
- Testing
- AGS-004
- Where
- 9 sites in United States, Canada
- Volunteers
- 53 people
- Sponsor
- Argos Therapeutics
HIV1 Infection, HIV 2 Infection
A Study to Evaluate the Performance, and Usability of TruPlex HIV/HepB/Syphilis Rapid Test
To evaluate the clinical performance of each analyte (HIV, HBsAg, and Syphilis) on the TruPlex HIV/HepB/Syphilis Rapid Test (TruPlex Test) using capillary blood (fingerstick), EDTA whole blood, EDTA-plasma, and SST-serum samples…
- Conditions
- HIV1 Infection, HIV 2 Infection, Syphilis Infection, Hepatitis B Infection
- Trial name
- NCT07569913
- Testing
- TruPlex HIV/HepB/Syphilis Rapid Test
- Where
- Australia
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- bioLytical Laboratories
Multiplex Testing of HIV, HBV, HCV and Syphilis, HIV
Clinical Performance Evaluation of MagIA IVD-MD Multiplex Testing (HIV/HBV/HCV/Syphilis)
Performance study to evaluate the clinical performance of the In-Vitro Diagnostics Medical Device MagIA H3S (a Multiplex Point-of-Care test for the combined detection of Human Immunodeficiency Virus (HIV), Hepatitis B and C and…
- Conditions
- Multiplex Testing of HIV, HBV, HCV and Syphilis, HIV, HBV, HCV
- Trial name
- MAGICS IBCS (NCT07170748)
- Where
- 2 sites in Côte d’Ivoire, Kenya
- Volunteers
- 2,950 people, healthy volunteers welcome
- Sponsor
- MagIA Diagnostics
HIV Infections
Rapid Test and Treat Dolutegravir Plus Lamivudine Study in Newly Diagnosed Human Immunodeficiency Virus (HIV)-1 Infected Adults
Early initiation of antiretroviral therapy (ART) reduces morbidity and mortality for individuals infected with HIV. Suppressing viral replication with ART also reduces the potential for transmission of HIV.
- Trial name
- NCT03945981
- Testing
- Dolutegravir + Lamivudine FDC
- Where
- 16 sites in United States
- Volunteers
- 131 people
- Sponsor
- ViiV Healthcare
HIV Infections
Testing of INSTI™ HIV-1 Antibody Test Kit in Volunteer Subjects at Risk for HIV Infection
Each year up to 22 million persons in the US are tested for HIV. Currently available "rapid" tests do not provide test results for at least 30 minutes from the collection of serum and plasma from the subject.
- Trial name
- NCT00514605
- Testing
- Behavioral counseling, HIV-1 Antibody Test Kit
- Where
- 14 sites in United States
- Volunteers
- 2,500 people, healthy volunteers welcome
- Sponsor
- bioLytical Laboratories
HIV Infections
Clinical Sensitivity of Clearview Rapid Tests in 12-17 y/o Pediatric Population
This study is to establish the clinical sensitivity of the Chembio Diagnostics Systems, Inc. Clearview COMPLETE HIV 1/2 Assay and Clearview HIV 1/2 Stat-Pak Assay (Clearview HIV tests) in pediatric subjects who are between 12 and…
- Trial name
- NCT00567749
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Chembio Diagnostic Systems, Inc.
HIV Infections, AIDS
Test Albuvirtide in Experienced Patients
The purpose of this study is to evaluate the efficacy and safety of albuvirtide combined with lopinavir-ritonavir (LPV/r) in HIV-1-infected patients who failed first-line antiretroviral therapy (ART).
- Trial name
- TALENT (NCT02369965)
- Testing
- albuvirtide, lopinavir-ritonavir, tenofovir
- Where
- 12 sites in China
- Volunteers
- 418 people
- Sponsor
- Frontier Biotechnologies Inc.
Screening for the Presence of HIV-1, RNA and HBV DNA in Blood Donations
Evaluation of HIV-1, HCV and HBV Blood Screening Tests With Human Blood Donor Specimens
The purpose of this study is to validate the performance characteristics of an assay that tests for HIV-1, HCV and HBV on an automated blood bank instrument for registration submission.
- Trial name
- NCT00552214
- Testing
- Blood test
- Where
- Taiwan
- Volunteers
- 10,290 people, healthy volunteers welcome
- Sponsor
- Novartis
Health Risk Behaviors
Sexually Active Adolescent Focused Education
SAAFE will be pilot tested in 2 geographically distinct areas (Washington, DC and Deep South) with 100 participants from each site to 1) primarily assess the efficacy of improved self-efficacy, knowledge about HIV/STIs and…
- Trial name
- SAAFE (NCT03646032)
- Testing
- SAAFE, Control
- Where
- 2 sites in United States
- Volunteers
- 178 people, healthy volunteers welcome
- Sponsor
- Benten Technologies, Inc.
Treponema Pallidum, Treponema Pallidum Infection
This Study Evaluates the ALPCO Syphilis-T and Syphilis-NT CLIA Kits for Detecting Syphilis Antibodies in Serum and Plasma. Samples From At-risk, HIV-positive, Pregnant, and Healthy Individuals Will Assess Assay Performance Versus Established Comparator Tests.
This study will evaluate the clinical performance of two investigational diagnostic kits developed by ALPCO: the Syphilis-T CLIA Kit and the Syphilis-NT CLIA Kit.
- Conditions
- Treponema Pallidum, Treponema Pallidum Infection, Syphilis Infection, Serum
- Trial name
- NCT07089836
- Testing
- ALPCO Syphilis-T, ALPCO Syphilis-NT CLIA Kits
- Where
- 6 sites in United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- American Laboratory Products Company
HIV Infections
Evaluation of the Performance of Chembio Diagnostics Systems, Inc. DPP® HIV 1/2 Rapid Test
This study has been designed to evaluate the performance of the Chembio Diagnostics Systems, Inc. DPP® HIV 1/2 rapid test. The device is intended to qualitatively detect the presence of antibodies against HIV-1/2 in oral fluid…
- Trial name
- NCT01032902
- Testing
- In Vitro Diagnostic Device
- Where
- 5 sites in United States
- Volunteers
- 2,808 people, healthy volunteers welcome
- Sponsor
- Chembio Diagnostic Systems, Inc.
HIV-1 Infection
A Safety and Immunogenicity Study of a Plasmid DNA Prime and MVA Boost Vaccine in HIV-1 Infected Adults on ART
GV-TH-01 is an open label Phase 1 study of 9 HIV-1 infected adults with suppressed viremia who started anti-retroviral therapy (ART) within 18 months of a negative HIV antibody test. This study has 3 phases.
- Trial name
- NCT01378156
- Testing
- JS7 plasmid DNA and MVA62B vaccine
- Where
- 3 sites in United States
- Volunteers
- 9 people
- Sponsor
- GeoVax, Inc.
Human Immunodeficiency Virus I Infection, Human Immunodeficiency Virus II Infection
A Study to Evaluate the Performance, Usability, and Result Interpretation of INSTI® HIV Self-Test
The objective of this study is to evaluate the performance, usability, and result interpretation of the INSTI® HIV Self-Test (referred to INSTI® HIV ST) in the intended use population across the United States (US).
- Trial name
- NCT06368453
- Testing
- INSTI® HIV Self-Test
- Where
- United States
- Volunteers
- 1,728 people, healthy volunteers welcome
- Sponsor
- bioLytical Laboratories
Human Immunodeficiency Virus I Infection, Human Immunodeficiency Virus II Infection
A Study to Evaluate the Performance of INSTI® HIV Self Test When Performed by Unobserved Intended Users in the US
The objective of this study is to evaluate the performance of INSTI® HIV Self Test with unobserved intended user population. The purpose of this study is to document if a lay person, unassisted by a healthcare worker, is able to…
- Trial name
- NCT07061912
- Testing
- NSTI® HIV Self-Test
- Where
- Canada
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- bioLytical Laboratories
HIV Infections
Phase II Study of AGS-004 as an Immunotherapeutic in Antiretroviral Therapy (ART)-Treated Subjects Infected With HIV
The purpose of this study is to examine the ability of AGS-004 to control HIV-1 replication and to determine if HIV-1 immunotherapy made with dendritic cells is safe and well tolerated, to determine if immunotherapy increases the…
- Trial name
- NCT00672191
- Testing
- AGS-004
- Where
- 12 sites in United States, Canada
- Volunteers
- 59 people
- Sponsor
- Argos Therapeutics
HIV Infections
Clinical Performance of Reveal G4 Rapid HIV-1 Antibody Test
To determine the efficacy of an improved rapid diagnostic test using venous whole blood and fingerstick whole blood. The clinical performance of Reveal G4 Rapid HIV-1 Antibody Test will be determined by comparing the results with…
- Trial name
- NCT02190578
- Testing
- Reveal G4
- Where
- 4 sites in United States
- Volunteers
- 1,649 people, healthy volunteers welcome
- Sponsor
- MedMira Laboratories Inc.
HIV Infections
The Effectiveness of HIV RNA Viral Load Testing in Determining Treatment Type in HIV-Infected Patients
To evaluate, in HIV-infected patients whose baseline CD4 count is 300 to 750 cells/mm3, whether an antiretroviral treatment regimen based upon clinical evaluation and CD4 counts plus HIV RNA viral load is more effective than a…
- Trial name
- NCT00002376
- Testing
- Indinavir sulfate, Lamivudine, Stavudine
- Where
- United States
- Volunteers
- 540 people
- Sponsor
- Merck Sharp & Dohme LLC
AIDS/HIV PROBLEM
Rapid Oral Test for Therapeutic Response in HIV/AIDS Patients
This study has been designed to evaluate a new oral test for therapeutic monitoring of HIV/AIDS patients that are receiving the combination Anti-Retroviral Therapy (cART).
- Trial name
- NCT01507142
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Gaia Medical Institute
Substance Abuse
Substance Treatment and HIV Testing and Referral System
The lack of substance screening and referral in healthcare settings is a significant problem with far-reaching consequences, including excess morbidity, premature mortality, and inflated healthcare costs.
- Trial name
- STaRS (NCT01488630)
- Testing
- STaRS
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Polaris Health Directions
HIV Infection
A Study of Patient Management in HIV-1 Infected Patients Found to Have the Genetic Marker HLA-B*5701
This is a retrospective observational study which follows on from CNA106030 (a study evaluating whether prospective genetic screening for HLA-B*5701 can reduce the incidence of hypersensitivity reactions to abacavir).
- Trial name
- NCT00435838
- Testing
- No Intervention -- Observational study
- Where
- 25 sites in Austria, Belgium and 5 more
- Volunteers
- 35 people
- Sponsor
- GlaxoSmithKline