Clinical trials: HIV-1 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
Human Immunodeficiency Virus Type 1 (HIV-1)
Bioequivalence Study of Individual Atazanavir and Cobicistat Compared With Atazanavir in Fixed-dose Combination With Cobicistat
The purpose of the study is to compare the pharmacokinetics and bioequivalence of atazanavir in a fixed-dose combination with cobicistat with that of atazanavir coadministered with cobicistat as single agents.
- Trial name
- Atazanavir (NCT01837719)
- Testing
- Atazanavir, Cobicistat, Atazanavir/Cobicistat FDC
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
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
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, Malaria
Drug Interaction Study Between Atovaquone and Antiretroviral Agents in HIV-1 Infected Patients
Malarone® (atovaquone/proguanil) is frequently used in malaria prophylaxis. Unfortunately, there are indications that certain anti-HIV agents may decrease atovaquone plasma levels by induction of atovaquone metabolism.
- Trial name
- NCT00421473
- Testing
- Atovaquone / Proguanil
- Where
- 5 sites in Netherlands
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
HIV Infections
A Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Protein BG505 SOSIP.GT1.1 Gp140 Vaccine, Adjuvanted in Healthy, HIV-uninfected Adults
This is a phase 1 clinical trial to evaluate the safety, tolerability, and immunogenicity of HIV-1 envelope protein BG505 SOSIP.GT1.1 gp140 trimer Vaccine, Adjuvanted, in up to 48 healthy HIV-uninfected adult volunteers.
- Trial name
- NCT04224701
- Testing
- BG505 SOSIP GT1.1 gp140 Vaccine, Adjuvanted
- Where
- 3 sites in United States, Netherlands
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- International AIDS Vaccine Initiative
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)
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
HIV Infections
HVTN Protocol 204 - A Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of a Multiclade HIV-1 DNA Plasmid Vaccine, VRC-HIVDNA016-00-VP, Followed by a Multiclade Recombinant Adenoviral Vector HIV-1 Vaccine Boost, VRCHIVADV014-00-VP, in HIV-1 Uninfected Adult Participants
The purpose of the study is to determine the safety of and immune response to a DNA HIV vaccine followed by an adenoviral vector HIV vaccine in HIV uninfected adults.
- Trial name
- NCT00125970
- Testing
- VRC-HIVDNA016-00-VP, VRC-HIVADV014-00-VP
- Where
- 12 sites in United States, Brazil and 3 more
- Volunteers
- 480 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
Evaluating the Safety and Immune Response to Three HIV Vaccine Schedules in Healthy, HIV-Uninfected Adults
NOTE: This study has stopped enrolling new participants, and all study vaccinations for currently enrolled participants have been stopped.
- Trial name
- NCT01783977
- Testing
- DNA-HIV-PT123 vaccine, NYVAC-HIV-PT1 vaccine, NYVAC-HIV-PT4 vaccine
- Where
- 8 sites in United States, Switzerland
- Volunteers
- 143 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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
Evaluating the Safety of and Immune Response to HIV-MAG DNA Vaccine With or Without Plasmid IL-12 Adjuvant Delivered Intramuscularly Via Electroporation Followed by VSV-gag HIV Vaccine Boost in Healthy, HIV-Uninfected Adults
Some vaccines may work better when given together with another substance known as an adjuvant or when given with an experimental procedure called electroporation (EP).
- Trial name
- NCT01578889
- Testing
- HIV-MAG vaccine, IL-12 pDNA adjuvant, VSV HIV gag vaccine
- Where
- 5 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
Safety of and Immune Response to Prime/Boost Vaccine Regimens in Healthy, HIV-1 Uninfected, Ad5 Seronegative Adults
Investigators will examine the safety of and immune responses to two vaccines expressing synthetic HIV proteins: NYVAC-B (a poxvirus), and rAd5 (an adenovirus).
- Trial name
- NCT00961883
- Testing
- NYVAC-B, rAd5
- Where
- 2 sites in Switzerland
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- HIV Vaccine Trials Network
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 Infections
First-Time-in-Human (FTIH) Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of VH4004280 in Healthy Participants
This FTIH study aims to evaluate the safety, tolerability and PK of the novel investigational Human immunodeficiency virus (HIV)-1 capsid inhibitor VH4004280 in healthy adults.
- Trial name
- NCT05163522
- Testing
- VH4004280, Midazolam
- Where
- United States
- Volunteers
- 73 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare