Clinical trials: HIV1 Infection
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
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
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-1 Infection
Safety and Pharmacokinetics of Oral Islatravir (MK-8591) Once Monthly in Participants at Low Risk of Human Immunodeficiency Virus 1 (HIV-1) Infection (MK-8591-016)
This study will evaluate the safety, tolerability and pharmacokinetics (PK) of 6 once-monthly doses of oral islatravir (60 mg and 120 mg) compared with placebo in adults at low risk of HIV-1 infection
- Trial name
- NCT04003103
- Testing
- Islatravir
- Where
- 9 sites in United States, Israel and 1 more
- Volunteers
- 242 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
HIV Infections
Safety and Efficacy Trial of a Dapivirine Vaginal Matrix Ring in Healthy HIV-Negative Women
This is a double-blind, randomised, placebo-controlled study to assess the safety and efficacy of a silicone elastomer vaginal matrix ring.
- Trial name
- NCT01539226
- Testing
- Dapivirine Vaginal Ring, 25 mg
- Where
- 7 sites in South Africa, Uganda
- Volunteers
- 1,959 people, healthy volunteers welcome
- Sponsor
- International Partnership for Microbicides, Inc.
HIV-1-infection
A Clinical Trial to Evaluate the Safety and Immunogenicity of Synthetic DNAs Encoding a Native-like HIV Env Trimer and Interleukin-12 (INO-6160), Alone or in a Prime-boost Regimen With 3M-052-AF + Alum Adjuvanted VRC HIV Env Trimer 4571 in Adult Participants Without HIV
This is a randomized open-label trial to examine the safety and immunogenicity of INO-6160 (synthetic DNAs encoding a native-like HIV Env Trimer and Interleukin-12), alone or in a prime-boost regimen with VRC HIV Env Trimer 4571…
- Trial name
- NCT05828095
- Testing
- INO-6160, 2 mg, Trimer-4571 / 100 mcg 3M-052-AF (5 mcg) + Alum (500 mcg)
- Where
- 3 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
Preventing Sexual Transmission of HIV With Anti-HIV Drugs
This study will determine whether anti-HIV drugs can prevent the sexual transmission of HIV among couples in which one partner is HIV infected and the other is not.
- Trial name
- NCT00074581
- Testing
- Atazanavir, Didanosine, Efavirenz
- Where
- 17 sites in United States, Botswana and 7 more
- Volunteers
- 3,526 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Human Immunodeficiency Virus Type 1 (HIV-1), HIV Infections
Drug Interactions Between Voriconazole and Atazanavir Coadministered as Atazanavir/Ritonavir in Healthy Participants
This study assesses the effects of voriconazole, 200 mg, administered twice daily (BID), on the steady-state pharmacokinetics of atazanavir administered as atazanavir/ritonavir, 300/100 mg once daily (QD), in healthy participants…
- Trial name
- NCT00833482
- Testing
- Voriconazole, Atazanavir, Ritonavir
- Where
- 2 sites in United States, Netherlands
- Volunteers
- 185 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
HIV Infections
Pivotal Phase 2b/3 ALVAC/Bivalent gp120/MF59 HIV Vaccine Prevention Safety and Efficacy Study in South Africa
This study will evaluate the preventive vaccine efficacy, safety, and tolerability of ALVAC-HIV (vCP2438) + Bivalent Subtype C gp120/MF59 in HIV-seronegative South African adults over 24 months and potentially up to 36 months…
- Trial name
- HVTN702 (NCT02968849)
- Testing
- ALVAC-HIV (vCP2438), Bivalent Subtype C gp120/MF59
- Where
- 14 sites in South Africa
- Volunteers
- 5,404 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
Evaluating the Safety and Efficacy of the VRC01 Antibody in Reducing Acquisition of HIV-1 Infection in Women
This study will evaluate the safety and efficacy of the human monoclonal antibody (mAb) VRC-HIVMAB060-00-AB (VRC01) in preventing HIV-1 infection in high-risk, HIV-uninfected women.
- Trial name
- NCT02568215
- Testing
- VRC01
- Where
- 21 sites in Botswana, Kenya and 5 more
- Volunteers
- 1,924 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
Safety and Pharmacokinetic Study of Dapivirine Gel (0.05%) Administered Rectally to HIV-1 Seronegative Adults
The purpose of this study is to evaluate the safety and pharmacokinetics (PK) of dapivirine gel (0.05%) administered rectally to HIV-1 seronegative adults.
- Trial name
- NCT03239483
- Testing
- Dapivirine gel
- Where
- 3 sites in United States, Thailand
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
Evaluating Safety and Immune Response to the HIV-1 CH505 Transmitted/Founder gp120 Adjuvanted With GLA-SE in Healthy, HIV-exposed Uninfected Infants
This study evaluated the safety and immune response in healthy HIV-exposed and uninfected infants to the protein vaccine, CH505TF gp120, adjuvanted with GLA-SE.
- Trial name
- HVTN 135 (NCT04607408)
- Testing
- CH505TF gp120, GLA-SE adjuvant
- Where
- South Africa
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- HIV Vaccine Trials Network
HIV Disease
Therapy to Elevate CD4 Counts in HIV-1 Disease
For more than 20 years, alpha-1-proteinase inhibitor therapy has been the standard treatment for patients who have inherited alpha-1-proteinase inhibitor deficiency.
- Trial name
- NCT01370018
- Testing
- alpha-1-Proteinase Inhibitor
- Where
- United States
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Institute for Human Genetics and Biochemistry
Pre-Exposure Prophylaxis of HIV-1 Infection
Study to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide (F/TAF) Fixed-Dose Combination Once Daily for Pre-Exposure Prophylaxis in Men and Transgender Women Who Have Sex With Men and Are At Risk of HIV-1 Infection
The primary objective of this study is to assess the rates of HIV-1 infection in Men (MSM) and transgender women (TGW) who have sex with men and who are administered daily emtricitabine/tenofovir alafenamide (F/TAF) or…
- Trial name
- DISCOVER (NCT02842086)
- Testing
- F/TAF, F/TDF
- Where
- 93 sites in United States, Austria and 9 more
- Volunteers
- 5,399 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Disease Transmission, Vertical, Vertical Human Immunodeficiency Virus Transmission
Trial of Three Neonatal Antiretroviral Regimens for Prevention of Intrapartum HIV Transmission
Giving anti-HIV medications to babies born of HIV positive mothers right after birth can lower the babies' risk of contracting HIV.
- Conditions
- Disease Transmission, Vertical, Vertical Human Immunodeficiency Virus Transmission, HIV Infections
- Trial name
- NCT00099359
- Testing
- Zidovudine, Nevirapine (NVP), Epivir (3TC)
- Where
- 17 sites in United States, Argentina and 3 more
- Volunteers
- 1,735 people, healthy volunteers welcome
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Bacterial Vaginosis, Vaginal Discharge
Study of How Bacterial Vaginosis and Its Treatment Affects Cervical and Vaginal Tissue
This is a research study to determine whether bacterial vaginosis (BV) changes the cervico-vaginal tissue (skin covering the cervix and vagina) and makes women at higher risk for getting HIV (Human Immunodeficiency Virus).
- Trial name
- CONRADBV (NCT01347632)
- Testing
- Metronidazole
- Where
- United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- CONRAD
HIV-1-infection on Healthy Volunteers
The Effect of Dolutegravir on Whole-body Insulin Sensitivity, Lipid and Endocrine Profile in Healthy Volunteers
This study will investigate changes in insulin resistance, lipid metabolism and endocrine profile in HIV-negative subjects exposed to dolutegravir (an antiretroviral drug used in HIV treatment) in order to investigate the role…
- Trial name
- DTG Clamp (NCT04771754)
- Testing
- Dolutegravir
- Where
- United Kingdom
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Chelsea and Westminster NHS Foundation Trust
HIV-1 Infection
A Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of Doravirine (MK-1439) (MK-1439-019)
This study aimed to investigate the influence of hepatic insufficiency on the pharmacokinetics (PK) of doravirine (MK-1439). In Part 1, PK of doravirine in participants with moderate hepatic insufficiency was compared with that…
- Trial name
- NCT02089659
- Testing
- Doravirine
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
HIV Infections
HIV Non Occupational Post-Exposure Prophylaxis (PEP)
This study will evaluate how safe and tolerable a combination of taking three-drugs will be for the purpose of preventing HIV transmission after a high-risk sexual contact exposure in HIV uninfected adults.
- Trial name
- NCT00594646
- Testing
- TRUVADA + Raltegravir
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Fenway Community Health
HIV Infections
Evaluating the Safety and Immunogenicity of an HIV-1 gp41 MPER-656 Liposome Vaccine in Healthy, HIV-uninfected Adult Participants
The purpose of this study is to evaluate the safety and immunogenicity of an HIV-1 gp41 MPER-656 liposome vaccine in healthy, HIV-uninfected adults.
- Trial name
- NCT03934541
- Testing
- MPER-656 Liposome Vaccine
- Where
- 6 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)