Clinical trials: HIV Testing
HIV in Adults
Taste Properties of Atazanavir and Cobicistat
The primary objective is to assess the taste properties of atazanavir (ATV) and cobicistat (COBI) alone and in combination as well as oral test formulations containing both ATV and COBI.
- Trial name
- NCT02307656
- Testing
- Atazanavir, Cobicistat, Active Pharmaceutical Ingredient
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
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
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
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
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
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
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.
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
HIV Positive
Evaluation of a Blood Test to Measure Immune Function in HIV Positive People Compared With HIV Negative People
The health of the immune system in HIV infected people is currently determined from a blood test measuring the number of cluster of differentiation 4 (CD4) T lymphocytes. These cells play a critical role in an immune response.
- Trial name
- QFM (NCT01904201)
- Where
- United States
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- QIAGEN Gaithersburg, Inc
HIV 1 Infection, HIV 2 Infection
A Study to Evaluate Performance, Usability, and Contrived Result Interpretation of TruPlex HIV/HepB/Syphilis Rapid Test
The objectives of this study are as follows: To evaluate the clinical performance of the TruPlex test using capillary blood, EDTA whole blood, EDTA plasma, and SST serum samples collected by trained operators in point-of-care…
- Conditions
- HIV 1 Infection, HIV 2 Infection, Syphilis Infection, Hepatitis B Infection
- Trial name
- NCT07563309
- Testing
- TruPlex HIV/HepB/Syphilis Rapid Test
- Where
- 3 sites in South Africa
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- bioLytical Laboratories
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.
Human Immunodeficiency Virus Infection, Hepatitis C
Comparison of Plasma & SMARTplasma for Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV) Antibody Testing
The purpose of this study is to compare the results for HIV and/or Hepatitis C Virus antibody testing when using routine plasma versus SMARTplasma from the same blood sample.
- Trial name
- NCT01447680
- Where
- 7 sites in United States
- Volunteers
- 1,600 people, healthy volunteers welcome
- Sponsor
- G & W Laboratories Inc.
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
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
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.