Clinical trials: HIV -1 Infection
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
A Clinical Trial to Evaluate the Safety and Immunogenicity of CH505M5 N197D mRNA-gp160 Followed by CH505 TF mRNA-gp160 in Adults in Overall Good Health Without HIV
This is a multicenter, open-label, non-randomized, dose escalation, first-in-human (FIH) trial to evaluate the safety and immunogenicity of CH505M5 N197D mRNA-gp160 and CH505 TF mRNA-gp160.
- Trial name
- NCT06557785
- Testing
- CH505M5 N197D mRNA-gp160, CH505 TF mRNA-gp160
- Where
- 7 sites in United States, Thailand
- Volunteers
- 53 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
HIV Infection
Study to Evaluate the Safety of Griffithsin in a Carrageenan Gel in Healthy Women
This is a two-part study. The first part is a single-dose open label design. The second part employs a multiple dose, randomized, placebo controlled study design.
- Trial name
- NCT02875119
- Testing
- Griffithsin Gel
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Population Council
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)
Infection, Human Immunodeficiency Virus
Phase 1, Open Label, Two Arm, Fixed Sequence Study to Evaluate the Effect of Rifampin and Rifabutin on GSK1349572 Pharmacokinetics in Healthy Male and Female Volunteers
This study will be a phase I, open label, two arm, fixed sequence crossover study to investigate the effect of rifampin and rifabutin on the steady state pharmacokinetics (PK) of GSK1349572 and the safety and tolerability of…
- Trial name
- NCT01231542
- Testing
- GSK1349572, Rifampin, Rifabutin
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV Infections
Safety and Pharmacokinetics of Dapivirine/Maraviroc Vaginal Ring
The purpose of this study is to assess the pharmacokinetics of the combination dapivirine and maraviroc vaginal ring and determine whether it is safe when used continuously for 28 days by healthy women in the United States.
- Trial name
- NCT01363037
- Testing
- Dapivirine Vaginal Ring, Maraviroc Vaginal Ring, Dapivirine-Maraviroc Vaginal Ring
- Where
- 3 sites in United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- International Partnership for Microbicides, Inc.
Tuberculosis
Safety and Immunogenicity Study of BCG, H4:IC31, and H56:IC31 Revaccination in Healthy Adolescents
The aims of the phase 1b trial described here are to facilitate identification of assays and immune responses that could then be evaluated as correlates of risk and correlates of protection in efficacy studies and ultimately to…
- Trial name
- NCT02378207
- Testing
- H4:IC31, H56:IC31, BCG
- Where
- South Africa
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Aeras
HIV Infections
Evaluating the Safety of and Immune Response to the VSV-Indiana HIV Vaccine in Healthy, HIV-Uninfected Adults
The purpose of this study is to evaluate the safety and immune response to an HIV vaccine in HIV-uninfected adults. Study researchers will also determine the maximum dose of the vaccine that participants can safely receive.
- Trial name
- NCT01438606
- Testing
- VSV-Indiana HIV gag vaccine
- Where
- 4 sites in United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV-1-Associated Cognitive Motor Complex
The Prevalence of Neurocognitive Disorder in a Primary Care-based HIV Cohort Compared to a HIV-negative Control Cohort -
To determine the prevalence of HIV associated Neurological Disorder (HAND) in a population of HIV positive patients within a primary care setting compared with the HIV negative population.
- Trial name
- CNS HAND (NCT01434563)
- Volunteers
- 326 people, healthy volunteers welcome
- Sponsor
- Holdsworth House Medical Practice
Healthy
A Study to Evaluate Safety, Acceptability, Pharmacokinetics, and ex Vivo Pharmacodynamics of TMC278 Long Acting Formulation in HIV-1 Seronegative Participants
The purpose of this study is to evaluate the safety, acceptability, pharmacokinetics (what the body does to the medication), and ex vivo (tested outside the body) pharmacodynamics (what the medication does to the body) of TMC278…
- Trial name
- NCT01656018
- Testing
- TMC278, Long acting (LA)
- Where
- United States
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
HIV Infections
Safety of and Immune Response to an HIV-1 Vaccine (ALVAC-HIV vCP1521) in Infants Born to HIV Infected Mothers
The purpose of this study is to test the safety of and immune response to an HIV-1 vaccine, ALVAC-HIV vCP1521, given to infants born to HIV-1 infected mothers in Uganda.
- Trial name
- NCT00098163
- Testing
- ALVAC-HIV vCP1521, ALVAC HIV-1 vCP1521
- Where
- Uganda
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
Safety and Immunogenicity Study of Ad26-ENVA and Ad35-ENV HIV Vaccines in Healthy HIV-uninfected Adults
The purpose of this study is to evaluate the safety and tolerability of Ad26.ENVA.01 and Ad35-ENV in low-risk for HIV-uninfected healthy adults administered in heterologous and homologous prime-boost regimens at different time…
- Trial name
- NCT01215149
- Testing
- Ad35-ENV vaccine, Ad26.ENVA.01 vaccine
- Where
- 6 sites in United States, Kenya and 2 more
- Volunteers
- 218 people, healthy volunteers welcome
- Sponsor
- International AIDS Vaccine Initiative
HIV Infection
CASI-Plus mHealth for Ukraine's APS Program (Aim 1)
The CASI-Plus mHealth intervention seeks to improve partner elicitation and testing as part of assisted partner services (APS) in Ukraine, through a mHealth client engagement tool using computer-assisted self-interview (CASI).
- Trial name
- NCT06971120
- Where
- 2 sites in Ukraine
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- University of Washington