Clinical trials: sponsored by ViiV Healthcare
HIV, HIV Infections
A Study to Evaluate Efficacy, Safety and Tolerability in Antiretroviral Therapy (ART)-Experienced Participants of at Least 50 Years of Age Living With Human Immunodeficiency Virus (HIV) With Virologic Suppression Who Switch to DTG/3TC FDC From BIC/FTC/TAF
The study aims at evaluating the maintenance of virologic suppression of dolutegravir/lamivudine (DTG/3TC) fixed dose combination (FDC) at Week 48 post-switch from bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) in…
- Trial name
- EYEWITNESS (NCT05911360)
- Testing
- DTG/3TC
- Where
- 56 sites in United States, Austria and 10 more
- Volunteers
- 205 people
- Sponsor
- ViiV Healthcare
Infection, Human Immunodeficiency Virus, HIV Infections
Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current Antiretroviral Regimen in Virologically Suppressed HIV-1-infected Adults
The Antiretroviral Therapy as Long Acting Suppression (ATLAS) study is being conducted to establish if human immunodeficiency virus type-1 (HIV-1) infected adult subjects with current viral suppression on a regimen with 2…
- Trial name
- NCT02951052
- Testing
- Cabotegravir (CAB) tablet, Rilpivirine (RPV) tablet, Cabotegravir - Injectable Suspension (CAB LA)
- Where
- 113 sites in United States, Argentina and 11 more
- Volunteers
- 618 people
- Sponsor
- ViiV Healthcare
HIV Infections
Mass Balance and Absolute Oral Bioavailability of [14C]VH4524184
The purpose of the study is to assess the bioavailability, mass balance, pharmacokinetics, metabolism and excretion of radiolabeled (14C) VH4524184.
- Trial name
- NCT07636928
- Testing
- VH4524184, [14C]VH4524184 microdose, [14C]VH4524184
- Where
- Netherlands
- Volunteers
- 9 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 to Evaluate the Efficacy, Safety, Participant Choice and Preference of an Oral Once-daily Regimen or a Long-acting Injectable Regimen Every Two Months for Treatment of Human Immunodeficiency Virus (HIV-1) in Adults Who Have Not Previously Taken Antiretroviral Therapy
This is a multicentre study carried out in participants living with human immunodeficiency virus type 1 (HIV-1) who have not previously been treated with any antiretroviral therapies.
- Trial name
- VOLITION (NCT05917509)
- Testing
- DTG/3TC, Cabotegravir (CAB) LA, Rilpivirine (RPV) LA
- Where
- 47 sites in United States, Argentina and 7 more
- Volunteers
- 171 people
- Sponsor
- ViiV Healthcare
HIV Infections
A Study to Investigate Cabotegravir for Neonates Exposed to HIV-1
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) of cabotegravir in neonates exposed to human immunodeficiency virus (HIV)-1.
- Trial name
- CABNATE (NCT07275606)
- Testing
- Oral CAB, IM CAB LA
- Where
- South Africa
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV Infections
A Study to Evaluate VH4524184 Tablet Absorption, Effects of Food, and Interactions With Other Drugs in Healthy Adults
The aim of the study is to gather information on how the drug behaves in healthy adults, how it is absorbed, and how it interacts when taken with other medicines.
- Trial name
- NCT07066722
- Testing
- VH4524184, Itraconazole, Rifabutin
- Where
- 2 sites in United States
- Volunteers
- 126 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV Infections
A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Two Different Formulations of Long-acting Cabotegravir in Healthy Adult Participants
The primary purpose of the study is to investigate the safety, tolerability, and pharmacokinetic (PK) profiles of two different cabotegravir formulations in healthy adult participants.
- Trial name
- NCT06033547
- Testing
- Cabotegravir Formulation F, Cabotegravir Formulation G
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV Infections
Dolutegravir Study in HIV-1 Participants Completing IMPAACT Studies P1093 and P2019
Dolutegravir is a potent integrase strand transfer inhibitor. Abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) is a fixed dose combination regimen containing two nucleoside reverse transcriptase inhibitors and dolutegravir.
- Trial name
- NCT03016533
- Testing
- Dolutegravir film-coated tablets, Dolutegravir film-coated dispersible tablets, ABC/DTG/3TC immediate release tablets
- Where
- 17 sites in United States, Botswana and 5 more
- Volunteers
- 100 people
- Sponsor
- ViiV Healthcare
HIV Infections
A Study to Investigate Safety, Tolerability, and Pharmacokinetics (PK) of VH4524184 and the Potential for Changes in Cytochrome P450 3A (CYP3A) Activity
This study is designed to investigate the safety, tolerability and PK of VH4524184 (GSK4524184) and the potential of VH4524184 to inhibit or induce CYP3A activity in healthy participants.
- Trial name
- NCT05631704
- Testing
- VH4524184, Midazolam
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV Infections
A Study to Investigate Pharmacokinetics, Safety and Tolerability of Long-Acting Cabotegravir Plus Recombinant Human Hyaluronidase PH20 in Healthy Adult Participants
This is an open-label, dose-escalation study to investigate the safety, tolerability and pharmacokinetics (PK) of single subcutaneous (SC) administration of long acting (LA) Cabotegravir (CAB) 200 milligrams per milliliter…
- Trial name
- NCT05418868
- Testing
- Cabotegravir 200 mg/mL, Cabotegravir >=400 mg/mL, Cabotegravir Formulation I
- Where
- 3 sites in United States
- Volunteers
- 214 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
Safety and Efficacy of Dolutegravir/Lamivudine (DTG/3TC) in Therapy-naive Human Immunodeficiency Virus-1 (HIV-1) Infected Adolescents
First-line antiretroviral regimens are highly efficacious and generally well tolerated. However, as these regimens need to be taken life-long, there is growing concern about long-term toxicities associated with these regimens.
- Trial name
- NCT03682848
- Testing
- DTG + 3TC FDC
- Where
- 8 sites in Kenya, South Africa and 1 more
- Volunteers
- 32 people
- Sponsor
- ViiV Healthcare
HIV Infections
A Study to Investigate if Long Acting Cabotegravir (CAB) and Lenacapavir (LEN) Injections Are Tolerable and Acceptable When Administered to Healthy Adults Without HIV
This study will evaluate the tolerability and acceptability of injection site reactions (ISRs) of two long-acting (LA) injectables.
- Trial name
- NCT06970223
- Testing
- Cabotegravir long-acting, Lenacapavir long-acting
- Where
- United States
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV Infections
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of VH4011499 Compared to Placebo in Adults Without HIV
The purpose of this study is to investigate safety, pharmacokinetics and tolerability following single ascending dose (SAD) and multiple ascending doses (MAD) of VH4011499 administered subcutaneously (SC) and intramuscularly (IM)…
- Trial name
- NCT06724640
- Testing
- VH4011499 low dose Injection, VH4011499 high dose Injection
- Where
- 2 sites in United States
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV Infections
A Study to Investigate the Antiviral Effect, Safety, Tolerability and Pharmacokinetics of VH3739937 in in Treatment-Naive Adults Living With HIV-1
The primary purpose of this study is to assess the antiviral activity of VH3739937 in Human Immunodeficiency Virus Type-1 (HIV-1) infected treatment naive (TN) participants during monotherapy.
- Trial name
- NCT06061081
- Testing
- VH3739937
- Where
- 18 sites in United States, Argentina and 4 more
- Volunteers
- 21 people
- Sponsor
- ViiV Healthcare
HIV Infections
Proof of Concept Treatment Study of Orally Administered VH4004280 or VH4011499 in HIV-1 Infected Adults
The primary purpose of the study is to evaluate the antiviral activity of orally administered VH4004280 and VH4011499 monotherapy over 10 days in human immunodeficiency virus (HIV-1) infected Treatment-Naïve (TN) participants.
- Trial name
- CINNAMON (NCT06039579)
- Testing
- VH4004280, VH4011499, Antiretroviral therapy
- Where
- 20 sites in United States, Argentina and 7 more
- Volunteers
- 44 people
- Sponsor
- ViiV Healthcare
HIV Infections
Description of Real World Antiviral Effectiveness and Sustainability of the 2-Drug Regimen Dolutegravir + Lamivudine in Untreated and Pre-treated Patients in Routine Clinical Care in Germany
This is a prospective, non-interventional, multi-center study, in participants with clinical indication of Human Immunodeficiency Virus (HIV)-1 infection.
- Trial name
- URBAN (NCT03754803)
- Testing
- HIV symptom distress module (SDM) questionnaire, HIV treatment satisfaction questionnaire (TSQ)
- Where
- 18 sites in Germany
- Volunteers
- 376 people
- 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