Clinical trials: sponsored by ViiV Healthcare
HIV Infections
VH4524184 Proof-of-Concept in Treatment-Naïve Adults Living With HIV-1
The purpose of this study is to evaluate the safety, tolerability, ability of VH4524184 when given alone to reduce the amount of HIV (viral load) in people with HIV-1 infection who have never received antiretroviral therapy…
- Trial name
- NCT06214052
- Testing
- VH4524184, Antiretroviral therapy
- Where
- 17 sites in United States, Argentina and 3 more
- Volunteers
- 22 people
- Sponsor
- ViiV Healthcare
HIV Infections
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Cabotegravir Ultra Long-acting (CAB ULA) Following Switch From Cabotegravir Long-acting (CAB LA) in Healthy Adults
This study will assess the pharmacokinetics (PK), safety, and tolerability of CAB ULA administered every 4 months (Q4M) following administration of CAB LA every 2 months (Q2M), in healthy adult volunteers.
- Trial name
- NCT06786520
- Testing
- CAB LA, CAB ULA
- Where
- 3 sites in United States
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV Infections
Fostemsavir Compassionate Use Named Patient Program for the Treatment of Human Immunodeficiency Virus 1 (HIV-1)
Compassionate use access to fostemsavir (GSK3684934, formerly BMS-663068) for the treatment of HIV infection in individuals with multidrug resistant HIV-1 infection who are experiencing virologic failure and are unable to…
- Trial name
- NCT04233047
- Testing
- Fostemsavir
- Sponsor
- ViiV Healthcare
HIV Infections
VH3739937 Phase 1 Multiple Ascending Dose (MAD) Study in Healthy Volunteers Including Relative Bioavailability (RBA), Optional Food Effect (FE), and Drug-drug Interaction (DDI)
This study will assess safety, tolerability and pharmacokinetic (PK) of VH3739937 in healthy participants.
- Trial name
- NCT06533280
- Testing
- Part A, C and D: VH3739937 500 mg, Part A: VH3739937 100 mg, Part B: Treatment A
- Where
- United States
- Volunteers
- 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
Study Using CABENUVA™ for the Treatment of Human Immunodeficiency Virus (HIV)-1, Administered in Infusion Centers (IC) or Alternate Sites of Administration (ASA) in the United States (U.S.)
GLACIER (Giving Long Acting CABENUVA in an Infusion center/ASA) is an interventional study examining the administration of CABENUVA (Cabotegravir long acting [LA] plus Rilpivirine LA) intramuscular (IM) in infusion centers/ASAs…
- Trial name
- GLACIER (NCT04982445)
- Testing
- CABENUVA
- Where
- 15 sites in United States
- Volunteers
- 44 people
- Sponsor
- ViiV Healthcare
HIV Infections
A Study to Investigate the Effect of Food on the Bioavailability of a Capsid Inhibitor (CAI) in Male and Female Healthy Participants
The purpose of this study is to evaluate effect of food (in fasted and fed conditions) on the bioavailability of CAI VH4011499.
- Trial name
- NCT06368986
- Testing
- VH4011499 Dose A, VH4011499 Dose B
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV Infections
'COMBINE-2': Real-world Evidence for Effectiveness of Two Drug Regimen, Antiretroviral Therapy With Integrase Inhibitors Plus a Reverse Transcriptase Inhibitor
Dolutegravir (DTG) is a well-tolerated 2nd generation integrase strand transfer inhibitor (INSTI); rilpivirine (RPV) is a well-tolerated non- nucleoside reverse transcriptase inhibitors (NNRTI) and lamivudine (3TC) is a…
- Trial name
- NCT04019873
- Testing
- Dolutegravir (DTG), Lamivudine (3TC), Rilpivirine (RPV)
- Where
- Spain
- Volunteers
- 774 people
- Sponsor
- ViiV Healthcare
HIV Infections
A Study to Investigate the Potential Drug-Drug Interaction Between VH4524184 and Oral Contraceptive (Loestrin) in Healthy Adult Female Participants
This study aims to assess any impact of VH4524184 on the pharmacokinetic (PK) profile of an ethinyl estradiol (EE) and norethindrone acetate (NEA) containing oral contraceptive (OC) administered to healthy adult female…
- Trial name
- NCT06310616
- Testing
- VH4524184, Loestrin
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Human Immunodeficiency Virus Type 1 (HIV-1)
Study to Assess the Effects of Cabotegravir (CAB) and Rilpivirine (RPV) Long-Acting (LA) Injections Following Sub-cutaneous (SC) Administration Compared With Intramuscular (IM) Administration in Adult Participants Living With Human Immunodeficiency Virus (HIV-1) Infection in the FLAIR Study
This study will assess the pharmacokinetics, safety, tolerability, maintenance of virological suppression and patient reported outcomes for participants receiving CAB and RPV LA injections following SC administration in the…
- Trial name
- NCT05896748
- Testing
- Cabotegravir - Injectable Suspension (CAB LA), Rilpivirine - Injectable Suspension (RPV LA)
- Where
- 30 sites in United States, Canada and 4 more
- Volunteers
- 94 people
- Sponsor
- ViiV Healthcare
HIV Infections
Dolutegravir/Rilpivirine, Antiretroviral Efficacy Study Using Real-world Data in Subjects With Human Immunodeficiency Virus (HIV)-1
This was a prospective, non-interventional, single-arm, multi-center study aimed at gathering real-world data on JULUCA use in routine clinical care in Germany, to supplement clinical trial data to further improve/optimize care…
- Trial name
- JUNGLE (NCT03518060)
- Testing
- JULUCA
- Where
- 23 sites in Germany
- Volunteers
- 209 people
- Sponsor
- ViiV Healthcare
HIV Infections
A Study to Evaluate the Antiviral Effect, Safety and Tolerability of GSK3810109A in Viremic Human Immunodeficiency Virus (HIV)-1 Infected Adults
This study is to evaluate antiviral activity, efficacy, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of GSK3810109A in HIV-1 infected treatment naive adults.
- Trial name
- NCT04871113
- Testing
- GSK3810109A, Dolutegravir+lamivudine SOC regimen
- Where
- 24 sites in United States, Argentina and 4 more
- Volunteers
- 62 people
- Sponsor
- ViiV Healthcare
HIV Infections
Pharmacokinetics, Safety, Tolerability of Dolutegravir/Rilpivirine in Pediatrics
The purpose of this study is to provide data on the pharmacokinetic (PK), safety, tolerability, efficacy and acceptability of this fixed dose combination (FDC) single tablet 2-drug regimen for virologically suppressed (HIV-1 RNA…
- Trial name
- NCT05674656
- Testing
- Dolutegravir/Rilpivirine FDC
- Where
- 8 sites in United States
- Volunteers
- 20 people
- 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
Regimen Switch to Dolutegravir + Rilpivirine From Current Antiretroviral Regimen in Human Immunodeficiency Virus Type 1 Infected and Virologically Suppressed Adults (SWORD-1)
The aim of this study was to determine if virologically suppressed human immunodeficiency virus type 1 (HIV-1) infected adults on an antiretroviral regimen (including 2 nucleoside reverse transcriptase inhibitors [NRTIs] plus a…
- Trial name
- NCT02429791
- Testing
- DTG 50 mg, RPV 25 mg, CAR
- Where
- 65 sites in United States, Argentina and 11 more
- Volunteers
- 510 people
- Sponsor
- ViiV Healthcare
HIV Infections
Regimen Switch to Dolutegravir + Rilpivirine From Current Antiretroviral Regimen in Human Immunodeficiency Virus Type 1 Infected and Virologically Suppressed Adults (SWORD-2)
The aim of this study was to determine if virologically suppressed, human immunodeficiency virus type 1 (HIV-1) infected adults on an antiretroviral regimen (including 2 nucleoside reverse transcriptase inhibitors [NRTIs] plus a…
- Trial name
- NCT02422797
- Testing
- DTG 50 mg, RPV 25 mg, CAR
- Where
- 61 sites in United States, Argentina and 9 more
- Volunteers
- 518 people
- 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
A Study to Investigate the Relative Bioavailability and Food Effect of an Oral Capsid Inhibitor Tablet Formulation Compared With Other Oral Tablet Formulations in Male and Female Healthy Participants
This is a 3 part study of an investigational capsid inhibitor, VH4004280, in healthy adult participants. The purpose is to evaluate the effect of tablet formulation as well as food on bioavailability.
- Trial name
- NCT06168318
- Testing
- VH4004280 Formulation A, VH4004280 Formulation B, VH4004280 Formulation C
- Where
- United Kingdom
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV Infections
A Dose-Range Finding Clinical Trial Study in Human Immunodeficiency Virus (HIV-1) Infected Treatment-Naive Adults
This is a phase 2b, randomized, multicenter, parallel group, partially blind (to GSK3640254 doses [100, 150 and 200 milligrams {mg}]), active controlled clinical trial.
- Trial name
- DOMINO (NCT04493216)
- Testing
- GSK3640254, ABC/3TC, FTC/TAF
- Where
- 65 sites in United States, Argentina and 9 more
- Volunteers
- 161 people
- Sponsor
- ViiV Healthcare
Infection, Human Immunodeficiency Virus, HIV Infections
A Phase IIb Study to Evaluate a Long-Acting Intramuscular Regimen for Maintenance of Virologic Suppression (Following Induction With an Oral Regimen of GSK1265744 and Abacavir/Lamivudine) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected, Antiretroviral Therapy-Naive Adult Subjects
This study is a Phase IIb, randomized, multicentre, parallel group, open-label, study having an overall objective to evaluate the antiviral activity, tolerability, and safety of two intramuscular (IM) dosing regimens of GSK744 LA…
- Trial name
- NCT02120352
- Testing
- CAB Oral Tablets, CAB LA, ABC/3TC Oral tablets
- Where
- 50 sites in United States, Canada and 3 more
- Volunteers
- 309 people
- Sponsor
- ViiV Healthcare