Clinical trials: HIV I Infection
HIV I Infection, Tuberculosis
Evaluating the Safety and Immunogenicity of MTBVAC
The purpose of this study is to evaluate the safety and immunogenicity of MTBVAC in adolescents and adults living with and without HIV in South Africa
- Trial name
- HVTN605A5421 (NCT05947890)
- Testing
- MTBVAC, BCG
- Where
- 16 sites in South Africa
- Volunteers
- 276 people, healthy volunteers welcome
- Sponsor
- HIV Vaccine Trials Network
HIV -1 Infection
Safety Study of MucoCept-CVN
MucoCept-CVN uses a Lactobacillus strain native to the human vagina that is modified into a live biotherapeutic product (LBP) that continuously expresses a potent anti-HIV drug.
- Trial name
- NCT07181486
- Testing
- Live Biotherapeutic Product L. jensenii 1153-1666
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Craig Cohen, MD, MPH
HIV-1-infection
Safety and Pharmacokinetics of the Combination Broadly Neutralizing Antibodies, 3BNC117-LS-J and 10-1074-LS-J, in Healthy American and African Adults
This is a Phase 1/2 study to evaluate the safety, tolerability, and pharmacokinetics of two broadly neutralizing monoclonal human antibodies (bNAbs), 3BNC117-LS-J, which targets the CD4 binding site on HIV-1 envelope protein, and…
- Trial name
- NCT04173819
- Testing
- 3BNC117-LS-J, 10-1074-LS-J, Combination 3BNC117-LS-J and 10-1074-LS-J
- Where
- 9 sites in United States, Kenya and 3 more
- Volunteers
- 225 people, healthy volunteers welcome
- Sponsor
- International AIDS Vaccine Initiative
HIV-1-infection
Modelling the Interaction Between Rationally-designed Synthetic Model Viral Protein Immunogens
The objective of this experimental medicine study is to determine the extent to which different prime-boost combinations influence serum neutralising antibody breadth and associated B and T cells responses.
- Trial name
- EAVI2020_01 (NCT03816137)
- Testing
- ConM SOSIP, EDC ConM SOSIP, ConS UFO
- Where
- United Kingdom
- Volunteers
- 117 people, healthy volunteers welcome
- Sponsor
- Imperial College London
HIV Infections
Safety and Effectiveness of PENNVAX-B Vaccine Alone, With Il-12, or IL-15 in Healthy Adults
The purpose of this study is to determine the safety, tolerability, and immune response to the DNA HIV vaccine, PENNVAX-B alone, in combination with IL-12, or with 2 different doses of IL-15.
- Trial name
- NCT00528489
- Testing
- PennVax B, IL-12, IL-15
- Where
- 8 sites in United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV-1, HIV Infections
Safety and Immunogenicity Study of Candidate HIV-1 Vaccine Given to Healthy Infants Born to HIV-1/2-uninfected Mothers
Objectives: Safety and immunogenicity of MVA.HIVA vaccine in 20-week-old healthy Gambian infants born to HIV-1/2-uninfected mothers.
- Trial name
- PedVacc001 (NCT00982579)
- Testing
- MVA.HIVA
- Where
- The Gambia
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Medical Research Council
HIV-1-infection
IAP-086-1: A Phase 1 Single Ascending Dose First-Time in Human Study
Purpose: To assess the safety and tolerability of a single dose of IAP086 in persons with HIV suppressed on stable ART Participants: 30 people from UNC within 18 to 70years of age.
- Trial name
- NCT07596888
- Testing
- IAP086 0.3 mcg/kg, IAP086 1 mcg/kg, IAP086 3 mcg/kg
- Where
- 2 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
HIV Infections
A Study to Evaluate Pharmacokinetic (PK) and Safety of GSK1265744 in Subjects With Hepatic Impairment and Control Healthy Volunteers
This will be a Phase 1, open-label, parallel group, two-part, single-dose adaptive study in adults with moderate and mild (if needed) hepatic impairment and matched, healthy control subjects with normal hepatic function.
- Trial name
- NCT02354950
- Testing
- GSK1265744 30mg
- Where
- 3 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Prevention of HIV Infection, HIV Antibodies
Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-HIVMAB080-00-AB (VRC01LS), With Broad HIV-1 Neutralizing Activity, Administered Intravenously or Subcutaneously to Healthy Adults
Background: Antibodies help the body fight infection. VRC01LS is an antibody directed against HIV virus. HIV attacks the immune system. In animals, VRC01LS inactivated many types of HIV viruses.
- Conditions
- Prevention of HIV Infection, HIV Antibodies, Monoclonal Antibody, Human, Neutralizing Antibody
- Trial name
- NCT02599896
- Testing
- VRC-HIVMAB080-00-AB (VRC01LS), VRC-HIVMAB060-00-AB (VRC01)
- Where
- United States
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
Interventional Study of Mucosal and Antimicrobial Responses to Repeated Vaginal Applications of Tenofovir Gel in HIV Uninfected Women
Topical microbicides, substances that kill microbes, are being studied to prevent sexual transmission of HIV and other disease-causing agents.
- Trial name
- NCT00594373
- Testing
- Tenofovir gel
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Infection, Human Immunodeficiency Virus
Relative Bio-availability Study of Dolutegravir and Lamivudine Fixed Dose Combinations
Dolutegravir (DTG) and lamivudine (3TC) are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.
- Trial name
- NCT02738931
- Testing
- Dolutegravir 50 mg tablet, Lamivudine 300 mg tablet, Dolutegravir/Lamivudine 50 mg/300 mg Tablet (Product Code AA)
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV-1-infection, Hepatitis C, Chronic
Switch to Genvoya Followed by HCV Therapy With Epclusa Followed by Simplification of HIV Therapy With Biktarvy in Patients With HIV-HCV Co-Infected Subjects on Opioid Substitution Therapy
The study hypothesis is to determine the feasibility of switching HIV-HCV co-infected patients receiving methadone or buprenorphine/naloxone as opioid substitution therapy with suppressed HIV RNA viral load on current…
- Conditions
- HIV-1-infection, Hepatitis C, Chronic, Methadone Dependence, Opioid Dependence
- Trial name
- NCT03549312
- Testing
- Genvoya, Epclusa, Biktarvy
- Where
- Canada
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Saskatchewan Health Authority - Regina Area
Infection, Human Immunodeficiency Virus
Effect of Dolutegravir on Metformin Pharmacokinetics in Healthy Adult Subjects
This study will be a phase 1, open label, parallel group, three period crossover study to evaluate the effect of dolutegravir (DTG) on the steady state pharmacokinetics of metformin and on the safety and tolerability of…
- Trial name
- NCT02064374
- Testing
- Metformin 500 mg q12h, Dolutegravir 50 mg q24h, Dolutegravir 50 mg q12h
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV/AIDS
Safety and Immunogenicity Study of a DNA Vaccine Combined With Protein Vaccine Against HIV/AIDS
The primary objective of the proposed phase I trial is to evaluate the safety and tolerability of DNA-HIV-PT123 and AIDSVAX®B/E combination regimen.
- Trial name
- EV06 (NCT02376582)
- Testing
- DNA, AIDSVAX B/E
- Where
- 2 sites in Uganda
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- EuroVacc Foundation
HIV Infections
Safety and Immunogenicity Study of 2 Investigational Preventive HIV Vaccines
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of an adjuvanted GSK investigational HIV vaccine and Ad35-GRIN in 4 different regimens at months 1, 2, 3, and 4.
- Trial name
- NCT01264445
- Testing
- Adjuvanted GSK investigational HIV vaccine formulation 1, Adjuvanted GSK investigational HIV vaccine formulation 2, Ad35 investigational HIV vaccine
- Where
- 4 sites in Kenya, Uganda and 1 more
- Volunteers
- 147 people, healthy volunteers welcome
- Sponsor
- International AIDS Vaccine Initiative
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
Healthy
Vaccine Treatment for HIV-Infection
This study will determine the safety and side effects of an experimental adenoviral vector vaccine given to patients who previously received a different HIV vaccine (VRC-HIVDNA016-00-VP) in a prior NIAID study.
- Trial name
- NCT00108654
- Testing
- VRC-HIVADV014-00-VP
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of HIV-1 MN rsgp120 and Bivalent AIDSVAX B/E (HIV-1 MN rgp120/A244 rgp120) in Combination With QS-21 With or Without Alum in Healthy HIV-1 Uninfected Adults
To assess the safety and immune response to two experimental vaccines when formulated with QS-21 or QS-21 plus alum. To determine whether the new preparation of QS-21 in polysorbate 80 is less reactogenic than the QS-21…
- Trial name
- NCT00001096
- Testing
- MN rgp120/HIV-1 and A244 rgp120/HIV-1, QS-21, rgp120/HIV-1MN
- Where
- 4 sites in United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV/AIDS, Medication Adherence
Adherence Through Home Education and Nursing Assessment, Indonesia
Adherence to antiretroviral therapy (ART) drops sharply after prison release. Effective medication adherence training immediately before and after prison release may improve health outcomes and limit transmission of Human…
- Conditions
- HIV/AIDS, Medication Adherence, Substance Use
- Trial name
- ATHENA-I (NCT03397576)
- Testing
- ATHENA
- Where
- Indonesia
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- University of Illinois Chicago
Infection, Human Immunodeficiency Virus
Dolutegravir Renal Impairment Study
Dolutegravir (DTG, GSK1349572) is an integrase inhibitor being developed for the treatment of human immunodeficiency virus (HIV)-1 infection by GlaxoSmithKline (GSK) on behalf of Shionogi-ViiV Healthcare LLC.
- Trial name
- NCT01353716
- Testing
- Dolutegravir 50 mg
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare