Clinical trials: HIV1 Infection
- Condition HIV1 Infection
- Funder type Industry (pharma, biotech, devices)
- Accepts healthy volunteers yes
HIV Infections
A Safety and Acceptability Study of a Vaginal Ring Microbicide Delivery Method
The proposed study is a multi-centre, open-label crossover study to assess the safety and acceptability of a silicone elastomer vaginal ring (containing no drug) when inserted for a 12 week period in 200 healthy, sexually active…
- Trial name
- NCT00469170
- Testing
- intravaginal ring
- Where
- 4 sites in South Africa, Tanzania
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- International Partnership for Microbicides, Inc.
HIV-1-infection
Reversing the Epidemic in Africa With Choices in HIV Prevention (REACH)
Participants will be randomized (1:1) to one of two sequences of a vaginal ring (VR) containing 25mg of dapivirine to be inserted monthly for 24 weeks and 200 mg FTC/300 mg TDF oral tablets taken daily for 24 weeks.
- Trial name
- NCT03074786
- Testing
- Dapivirine, Truvada
- Where
- South Africa
- Volunteers
- healthy volunteers welcome
- Sponsor
- International Partnership for Microbicides, Inc.
HIV Infections
A Phase I Pharmacokinetics and Safety Study of Two Dapivirine Intravaginal Gels
IPM 012 is a double-blind, randomized, placebo-controlled phase I study conducted at one research center in Belgium among 36 healthy, HIV-negative women of 18-40 years of age, randomized in a 1:1:1 ratio to assess plasma, vaginal…
- Trial name
- NCT00613249
- Testing
- Dapivirine Gel 4750, 0.05%, 2.5g, Dapivirine Gel 4789, 0.05%, 2.5g
- Where
- Belgium
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- International Partnership for Microbicides, Inc.
HIV/AIDS
Safety and Pharmacokinetic Study of Oral Maraviroc and Maraviroc 1% Gel in HIV-1 Seronegative Adults
The purpose of the study is to evaluate the safety, acceptability, and PK/PD profile of maraviroc gel following rectal and vaginal administration. The study also includes oral exposure to maraviroc.
- Trial name
- NCT02346084
- Testing
- Maraviroc 300 mg tablet (PO) and Maraviroc 1% gel (PR and PV)
- Where
- United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- International Partnership for Microbicides, Inc.
HIV Infections
Clinical Study of TUTI-16 in HIV-1 Infected and Uninfected Subjects
This protocol represents the second in human study of TUTI-16, and is being conducted to continue to gather safety and human immunogenicity (anti-HIV-1 Tat titers) data of subcutaneously administered TUTI-16.
- Trial name
- THYMON-10001 (NCT01144026)
- Testing
- TUTI-16 (0.2mg), TUTI-16 (1.0 mg)
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Thymon, LLC
HIV Infections
Assessing the Safety of Dapivirine Gel and Film Formulations
This is a study to determine the safety of dapivirine gel and dapvirine film for healthy, HIV-uninfected women aged 18-45 years using the product for 7 daily doses.
- Trial name
- NCT01548560
- Testing
- Dapivirine Vaginal Film, Dapivirine Vaginal Gel
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- International Partnership for Microbicides, Inc.
HIV-1, HIV Infections
A Worldwide, Phase I, Dose-Escalating Study of a 3-Dose Regimen of the MRKAd5 (Clade B) Vaccine in Healthy Adults (V520-018)
This three stage study will evaluate the safety and tolerability of MRKAd5 HIV-1 Gag Vaccine. In Stage I subjects will be randomized to receive the vaccine at 1x10^9 viral particles/dose (vp/d) or placebo.
- Trial name
- NCT00849732
- Testing
- V520, Comparator: V520 (1x10^9 vp/d), Comparator: V520 (1x10^10 vp/d)
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
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
Human Immunodeficiency Virus Type 1
A Study to Evaluate the Pharmacokinetic Effects of Different Storage Conditions for a Long-Acting Nanosuspension of Rilpivirine on Pharmacokinetics
The purpose of this study is to compare the single-dose pharmacokinetics of rilpivirine (RPV) after intramuscular (IM) injection of rilpivirine long-acting parenteral formulation (RPV-LA) and 'aged' RPV-LA, in healthy adult…
- Trial name
- NCT02547870
- Testing
- Rilpivirine (RPV), Rilpivirine Long-Acting Parenteral Formulation (RPV-LA), Aged RPV-LA
- Where
- Belgium
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Janssen Infectious Diseases BVBA
Human Immunodeficiency Virus (HIV), HIV Pre-Exposure Prophylaxis
A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)
Researchers are looking for new medicines to prevent HIV-1 (Human Immunodeficiency Virus Type 1) infection. The goals of this study are to learn: If taking MK-8527 once a month works to prevent HIV-1 infection better than a…
- Trial name
- NCT07071623
- Testing
- MK-8527, Emtricitabine/tenofovir disoproxil (FTC/TDF)
- Where
- 30 sites in Kenya, South Africa and 1 more
- Volunteers
- 4,580 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
HIV Infections
A Study to Assess the Pharmacokinetics of Dapivirine (TMC120) Vaginal Microbicide Gel
Approximately 18 women will be enrolled in this single-center, double-blind, randomized Phase I study to assess vaginal tissue and fluid levels, plasma levels and pharmacokinetics of dapivirine (TMC120) gel, which will be applied…
- Trial name
- NCT00304642
- Testing
- dapivirine (TMC120) vaginal gel
- Where
- South Africa
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- International Partnership for Microbicides, Inc.
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.
HIV Infections
First-Time-in-Human (FTIH) Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of VH4011499 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 VH4011499 in healthy adults.
- Trial name
- NCT05393271
- Testing
- VH4011499, Midazolam
- Where
- 2 sites in United States
- Volunteers
- 73 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV-1-infection
Study of the Safety of Trogarzo™ Administered as an Undiluted "IV Push" or an Intramuscular Injection
This study is designed to assess the safety and pharmacokinetic profile of 800 mg Trogarzo once every two weeks administered via "IV Push" or intramuscular injection.
- Trial name
- NCT03913195
- Testing
- ibalizumab-uiyk
- Where
- 4 sites in United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- TaiMed Biologics Inc.
HIV Infections
Study of the Absorption, Metabolism, and Route of Elimination of a Novel Class of Anti-HIV 1 Drugs (BMS-955176) in Humans.
The purpose of this study is to assess the pharmacokinetics (PK), metabolism, routes and extent of elimination, safety and tolerability of a single oral dose of [14C] BMS-955176 in healthy male subjects.
- Trial name
- NCT02206711
- Testing
- BMS-955176
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV-1-infection, Hepatic Impairment
Study to Evaluate the Safety and PK of Elpida® in Healthy Subjects and Patients With Hepatic Impairment and to Assess the Impact of Food Intake and Drug-Drug Interactions With Other Antiviral Drugs
This is open label, phase 1 clinical study to evaluate the safety, tolerability and pharmacokinetics of Elpida® in healthy subjects and patients with hepatic impairment (Child - Pugh Class А and B), as well as to assess the…
- Trial name
- NCT03706898
- Testing
- Elpida®, Dolutegravir, Sofosbuvir
- Where
- Russia
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Viriom
Infection, Human Immunodeficiency Virus
A Randomized Study to Assess the Relative Bioavailability of New Formulations of GSK1265744 Long Acting Parental (LAP) in Healthy Adult Subjects
This is a single-center, randomized, open-label, 3 parallel treatment study in healthy adult subjects to assess the relative bioavailability of new formulations of GSK1265744 LAP 400 mg intra muscular compared to the current…
- Trial name
- NCT01754116
- Testing
- GSK1265744 30 mg oral, Midazolam 3 mg oral + GSK1265744 30mg oral, GSK1265744 400 mg (200 nm)
- Where
- United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Human Immunodeficiency Virus Infections
Study of Lopinavir/Ritonavir Tablets Versus Soft Gel Capsules and Once Daily Versus Twice Daily Administration, When Coadministered With Nucleoside Reverse Transcriptase Inhibitors in Antiretroviral Naive Human Immunodeficiency Virus Type 1 Infected Subjects
The purpose of this study was to compare the safety and tolerability of the to-be-marketed lopinavir/ritonavir (LPV/r) tablet formulation with the marketed soft gel capsule (SGC) formulation and to compare the safety…
- Trial name
- NCT00262522
- Testing
- lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)
- Where
- 129 sites in United States, Australia and 17 more
- Volunteers
- 664 people, healthy volunteers welcome
- Sponsor
- Abbott
HIV-1-infection
A Phase 1, Randomized Pharmacokinetics and Safety Study of Extended Duration Dapivirine Vaginal Rings
Participants will be randomized to one of three study vaginal rings (VRs) in a 1:1:1 ratio, 25 mg, 100 mg or 200 mg VRs.
- Trial name
- NCT03234400
- Testing
- Dapivirine Vaginal Ring, 25 mg, Dapivirine Vaginal Ring, 100 mg, Dapivirine Vaginal Ring, 200 mg
- Where
- 2 sites in United States
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- International Partnership for Microbicides, Inc.
Infection, Human Immunodeficiency Virus, HIV Infections
GSK3640254 First Time in Human (FTIH) Study in Healthy Volunteers
Human immuno deficiency virus 1 (HIV-1) infections continues to be a serious health threat throughout the world and development of medicines with new mechanism of action have an important role to play.
- Trial name
- NCT03231943
- Testing
- GSK3640254
- Where
- United Kingdom
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare