Clinical trials: sponsored by ViiV Healthcare
HIV Infections
A Study Evaluating Implementation Strategies for the Delivery of APRETUDE for Black cis-and Transgender Women in United States EHE Territories
The purpose of the study is to evaluate the appropriateness, adoption, feasibility, fidelity, and acceptability of implementation strategies and Cabotegravir (CAB) pre-exposure prophylaxis (PrEP).
- Trial name
- EBONI (NCT05514509)
- Testing
- APRETUDE, Cabotegravir tablet
- Where
- 22 sites in United States
- Volunteers
- 295 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV Infections
Study to Evaluate Pharmacokinetic (PK), Safety and Tolerability of Cabotegravir (CAB) 400 Milligrams Per Milliliter (mg/mL) Formulation in Healthy Adult Participants
This is an active control, randomized study to investigate the safety, tolerability and PK of repeat dose administration of long-acting CAB 400 mg/mL formulation intramuscular (IM) (gluteus medius and vastus lateralis) and…
- Trial name
- NCT04484337
- Testing
- Cabotegravir sodium (Oral Lead In), Cabotegravir 400 mg/mL, Cabotegravir 200 mg/mL
- Where
- 5 sites in United States, New Zealand
- Volunteers
- 138 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV Infections
A Study Evaluating Implementation Strategies for the Delivery of Cabotegravir in Low and High-Volume PrEP Site in the United States
This is a two-arm study evaluating the impact of two implementation strategy conditions, dynamic implementation and routine implementation on the feasibility of delivering of Cabotegravir PrEP in low and high-volume PrEP sites in…
- Trial name
- PILLAR (NCT05374525)
- Testing
- APRETUDE, Cabotegravir OLI
- Where
- 17 sites in United States
- Volunteers
- 287 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
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 Infections
GSK3739937 First-Time-In-Human (FTIH) Study in Healthy Volunteers
This study is a Phase 1, double-blind (sponsor-unblinded), randomized, placebo-controlled, single- and repeat-dose escalation study including a weekly oral dose (MAD) cohort and a relative bioavailability (RBA) and food effect…
- Trial name
- NCT04493684
- Testing
- GSK3739937 (PIB), GSK3739937 (Tablet)
- Where
- United States
- Volunteers
- 91 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
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 Infections
A Study to Investigate the Safety and Pharmacokinetics of a Single Dose of VH3810109 (Also Known as GSK3810109), Administered Either Subcutaneously (SC) With rHuPH20 or Intravenously (IV), in Healthy Adult Participants
An open-label, two part study to assess the safety, tolerability, and PK of VH3810109 in healthy adult participants. Participants will receive a single SC or IV dose of VH3810109 co-administered with rHuPH20 and will be followed…
- Trial name
- SPAN (NCT05291520)
- Testing
- VH3810109, rHuPH20
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV Infections
Drug-drug Interaction (DDI) Study of GSK3640254 With Darunavir/Ritonavir (DRV/RTV) and Etravirine (ETR)
This is an open-label, single-sequence, multiple-dose, 3 cohort study to investigate the effects of DRV/RTV and/or ETR on the pharmacokinetics (PK) of GSK3640254 and the effects of GSK3640254 on the PK of DRV/RTV and/or ETR.
- Trial name
- NCT04630002
- Testing
- GSK3640254, Darunavir/Ritonavir (DRV/RTV), Etravirine (ETR)
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV Infections
Pharmacokinetic Study of Cabotegravir and Rilpivirine Long-acting Intramuscular Injections in Healthy Adult Participants
This is a phase 1, open label study in healthy participants to assess the pharmacokinetics of cabotegravir and rilpivirine in plasma following the administration of a single 600 milligram (mg) and a 900 mg intramuscular (IM)…
- Trial name
- NCT04371380
- Testing
- Cabotegravir Tablets, Rilpivirine Tablets, Cabotegravir extended release suspension for injection (long-acting)
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV Infections
A Relative Bioavailability and Food-Effect Study of the Fixed Dose Combination of GSK3640254 and Dolutegravir (DTG) in Healthy Participants
This is a two part study to compare the relative bioavailability (BA) of 2 fixed dose combinations (FDCs) of GSK3640254/DTG with GSK3640254 and DTG administered together as single agents (Part 1) and to assess the effect of food…
- Trial name
- NCT04857892
- Testing
- GSK3640254, DTG, GSK3640254/DTG
- Where
- United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV Infections
Evaluation of Pharmacokinetic Interaction Between GSK3640254 and Caffeine, Metoprolol, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin in Healthy Adults
This is an open-label, single sequence study that is being conducted to investigate the potential drug-drug interaction (DDI) when GSK3640254 is co-administered with a cocktail of cytochrome P450 (CYP) enzymes and transporter…
- Trial name
- NCT04425902
- Testing
- GSK3640254 200 mg, Caffeine 200 mg, Metoprolol 100 mg
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV Infections
Effect of Therapeutic and Supratherapeutic Oral Doses of GSK3640254 on Cardiac Conduction Compared to Placebo and a Single Oral Dose of Moxifloxacin
This study will aim to evaluate the effect of therapeutic and supratherapeutic oral doses of GSK3640254 on cardiac conduction compared to placebo and a single oral dose of Moxifloxacin in healthy adult participants.
- Trial name
- NCT04563845
- Testing
- GSK3640254, Moxifloxacin
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV Infections
A Food-effect Study of the Pediatric Dispersible Tablet Formulations of TRIUMEQ® and DOVATO® in Healthy Adult Participants
This study will assess the effect of food on the pharmacokinetics (PK) of pediatric formulations of TRIUMEQ (dolutegravir [DTG] 5 milligrams [mg]/abacavir [ABC] 60 mg/lamivudine [3TC] 30 mg) dispersible tablets and DOVATO (DTG 5…
- Trial name
- NCT04827134
- Testing
- TRIUMEQ, DOVATO
- Where
- United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV Infections
Pharmacokinetics and Metabolism of 14 Carbon [14C]-GSK3640254
This is an open-label, single-center, single group, non-randomized, two-period, single sequence, mass balance study which will enroll 6 healthy male participants.
- Trial name
- NCT04507321
- Testing
- GSK3640254 Oral tablet, [14C]-GSK3640254 intravenous infusion, [14C]-GSK3640254 powder
- Where
- United Kingdom
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV Infections
Evaluation of the Safety, Tolerability and Pharmacokinetics (PK) of GSK3732394 First-Time-in-Human (FTIH) Study
This is a phase 1, 2-part, double-blind (sponsor-unblinded), randomized, placebo-controlled, FTIH study, that includes both single-ascending and multiple-ascending dose phase to assess the safety, tolerability, and…
- Trial name
- NCT03984812
- Testing
- GSK3732394
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
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
HIV Infections
A Safety, Tolerability, Acceptability, and Pharmacokinetic (PK) Study of Cabotegravir (CAB) in Healthy Human Immunodeficiency Virus (HIV)-Uninfected Chinese Men
The pre-exposure prophylaxis (PrEP) is an important component in the overall strategy for prevention of HIV infection. Cabotegravir (CAB) is an integrase strand transfer inhibitor currently in development for treatment and…
- Trial name
- NCT03422172
- Testing
- Oral CAB, CAB LA
- Where
- 3 sites in China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV Infections
A Relative Bioavailability and Food-Effect Study of GSK3640254 Tablet and Capsule Formulations in Healthy Participants
This is an open-label, 2 part, single-dose and crossover study conducted to assess the relative bioavailability of a tablet compared to a capsule of GSK3640254 and to assess the effect of food on the GSK3640254 tablet in healthy…
- Trial name
- NCT04263142
- Testing
- GSK3640254 Tablet, GSK3640254 Capsule
- Where
- United States
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Infection, Human Immunodeficiency Virus, HIV Infections
Effect of Rifabutin on the Pharmacokinetics of Oral Cabotegravir in Healthy Subjects
This is a Phase I, single-center, open-label, fixed-sequence, 2-period crossover study in healthy adults to evaluate the effect of oral rifabutin (RBT) 300 milligram (mg) on the pharmacokinetics of oral cabotegravir (CAB) 30…
- Trial name
- NCT03149848
- Testing
- Cabotegravir, Rifabutin
- Where
- United Kingdom
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV Infections
Effect of GSK3640254 on the Pharmacokinetics of a Combination Oral Contraceptive
This is an open-label, single-sequence, 1-way drug-drug interaction study to investigate the effect of GSK3640254 on the pharmacokinetics of a combination oral contraceptive containing ethinyl estradiol (EE) and levonorgestrel…
- Trial name
- NCT03984825
- Testing
- GSK3640254, Portia
- Where
- United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare