Clinical trials: sponsored by ViiV Healthcare
HIV Infections
The LATITUDE Study: Long-Acting Therapy to Improve Treatment SUccess in Daily LifE
The purpose of this study was to compare the efficacy, safety, and durability of two different strategies to treat participants with a history of sub-optimal adherence and control of their HIV infection: long-acting (LA)…
- Trial name
- NCT03635788
- Testing
- Standard of Care (SOC) Oral ART, Oral RPV, Oral CAB
- Where
- 33 sites in United States, Puerto Rico
- Volunteers
- 456 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV, Seroconversion, HIV
Accurate Staging of Immuno-virological Dynamics During Acute HIV Infection
In this prospective longitudinal study we aim to assess how immunologic and viral aspects of the human immunodeficiency virus (HIV) viral reservoir, established during early HIV infection and responsible for viral rebound at…
- Trial name
- ACS (NCT03449706)
- Testing
- Early combination anti-retroviral treatment
- Where
- Belgium
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- University Hospital, Ghent
HIV Infections
A Study to Investigate Safety, Tolerability and Pharmacokinetics of VH5356136 in Adult Participants Without HIV
The study aims to evaluate the safety, tolerability and pharmacokinetic (PK) properties of a single dose of VH5356136 in adult participants without human immunodeficiency virus (HIV).
- Trial name
- NCT07822477
- Testing
- VH5356136 Formulation 1, VH5356136 Formulation 2
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Tuberculosis, HIV
Dolutegravir/Lamivudine Dual Therapy for ART-naïve People With HIV and TB Receiving Rifampin-based TB Treatment
This will be a Phase IIIb Clinical Trial, an international multicenter, randomized, three-arm, non-comparative trial of efficacy, safety, and tolerability of the dual therapy regimen dolutegravir plus lamivudine either twice…
- Trial name
- DOVETAIL (NCT06497465)
- Testing
- Dolutegravir 50mg Tab, Dolutegravir/Lamivudine 50 MG-300mg Oral Tablet [DOVATO], Dolutegravir plus Tenofovir disoproxil fumarate (TDF)/ lamivudine (3TC)
- Where
- 5 sites in Brazil
- Volunteers
- 150 people
- Sponsor
- Johns Hopkins University
HIV Infections
A Phase 2b Study Evaluating VH4011499 Capsid Inhibitor Long-Acting Injectable Plus Cabotegravir in Treatment Naïve Adults (CINERGY)
The purpose of this Phase 2b study is to evaluate the efficacy and therapeutic window of chronically dosed VH4011499 paired with an integrase strand transfer inhibitor (INSTI).
- Trial name
- CINERGY (NCT07816250)
- Testing
- VH4011499, CAB, DTG/3TC
- Volunteers
- 200 people
- Sponsor
- ViiV Healthcare
HIV Infections
Lamivudine/Dolutegravir in Virologically Suppressed Subjects With Expected or Confirmed Resistance to Lamivudine
Dolutegravir (DTG) plus lamivudine (3TC) is a dual regimen combination recommended for both naïve and suppressed persons with HIV-1 infection1.
- Trial name
- VOLVER (NCT04880785)
- Testing
- Dolutegravir 50 MG / Lamivudine 300 MG Oral Tablet [Dovato]
- Where
- 17 sites in Spain
- Volunteers
- 167 people
- Sponsor
- Fundacion SEIMC-GESIDA
HIV, Tuberculosis
Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum
The purpose of this study was to evaluate the pharmacokinetic (PK) properties of antiretroviral (ARV) and anti-tuberculosis (TB) drugs administered during pregnancy and postpartum.
- Trial name
- NCT04518228
- Testing
- Bictegravir (BIC), Tenofovir alafenamide (TAF), Long-acting injectable formulation of cabotegravir (CAB LA)
- Where
- 23 sites in United States, Brazil and 6 more
- Volunteers
- 205 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
Attachment Inhibitor Comparison in Heavily Treatment Experienced Patients
The purpose of this study is to determine whether the BMS Attachment Inhibitor (BMS-663068) is effective in the treatment of heavily treatment experienced HIV-1 patients with multi-drug resistance.
- Trial name
- NCT02362503
- Testing
- BMS-663068
- Where
- 139 sites in United States, Argentina and 23 more
- Volunteers
- 371 people
- Sponsor
- ViiV Healthcare
Tuberculosis
A Trial of Stratified Patient-Centered Treatment Regimens for Active TB (SPECTRA-TB)
The A5414 study will evaluate whether treatment for drug-susceptible pulmonary tuberculosis (TB) can be tailored according to a participant's risk of an unfavorable outcome.
- Trial name
- NCT07595042
- Testing
- Isoniazid, Rifampin, Pyrazinamide
- Where
- 29 sites in Argentina, Australia and 14 more
- Volunteers
- 900 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
A Continued Access Study for Participants Transitioning From ViiV Healthcare-sponsored or ViiV Healthcare-collaborative Parent Studies for HIV Treatment
The purpose of this study is to provide continued access to the study treatment for participants from previous ViiV Healthcare studies who are still benefiting from it and do not have local access after completing the parent…
- Trial name
- PATH (NCT07393659)
- Testing
- Fostemsavir, Dolutegravir (DTG)/ Lamivudine (3TC)
- Where
- 4 sites in South Africa
- Volunteers
- 181 people
- Sponsor
- ViiV Healthcare
HIV-1-infection
Population Effectiveness of Dolutegravir Implementation in Sub-Saharan Africa
This is a prospective observational cohort study enrolling participants in South Africa and Uganda who are prescribed an HIV treatment regimen containing lamivudine, tenofovir, and dolutegravir, which is known as TLD.
- Trial name
- DISCO (NCT04066036)
- Testing
- This is an observational study only.
- Where
- 2 sites in South Africa, Uganda
- Volunteers
- 999 people
- Sponsor
- Massachusetts General Hospital
HIV Infections
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Suspension Injection of Investigational Capsid Inhibitors Compared to Placebo in Healthy Adults
The primary purpose of the study is to investigate safety and tolerability following single and multiple ascending subcutaneous (SC) and intramuscular (IM) doses of capsid inhibitors in healthy participants.
- Trial name
- NCT06012136
- Testing
- VH4004280, VH4011499
- Where
- 2 sites in United States
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Pre-Exposure Prophylaxis (PrEP), Breast Feeding
Tshireletso: Safety, Efficacy and Feasibility of Cabotegravir-LA PrEP in a Breastfeeding Population in Botswana
The goal of this this hybrid safety/implementation study is to evaluate whether using long-acting cabotegravir (CAB-LA) for HIV prevention (PrEP) is acceptable, feasible and safe in post-partum people who are breastfeeding.
- Trial name
- Tshireletso (NCT05986084)
- Testing
- Cabotegravir Injection [Apretude]
- Where
- 2 sites in United States, Botswana
- Volunteers
- 500 people
- Sponsor
- Beth Israel Deaconess Medical Center
HIV Infections
Study to Evaluate the Efficacy, Safety, and Tolerability of Long-acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor in HIV-1 Infected Therapy Naive Participants
The First Long-Acting Injectable Regimen (FLAIR) study is being conducted to establish if human immunodeficiency virus type-1 (HIV-1) infected adult participants whose virus is virologically suppressed on an integrase inhibitor…
- Trial name
- NCT02938520
- Testing
- Cabotegravir (CAB) tablet, Rilpivirine (RPV) tablet, Cabotegravir - Injectable Suspension (CAB LA)
- Where
- 108 sites in United States, Canada and 9 more
- Volunteers
- 631 people
- Sponsor
- ViiV Healthcare
HIV
IMplementation of CAB+RPV LA for People With HIV in Non-Metropolitan Areas
The goal of this implementation science study is to learn about the experience of receiving and providing cabotegravir + rilpivirine long-acting (CAB+RPV LA) injections as treatment for human immunodeficiency virus (HIV) for…
- Trial name
- IM-CAPABLE (NCT06451341)
- Testing
- Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), Feasibility of Intervention Measure (FIM)
- Where
- 4 sites in United States
- Volunteers
- 75 people
- Sponsor
- University of Nebraska
HIV Infections
A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study)
This clinical study is testing a new medication, VH4524184, to see if it can effectively treat HIV-1 in adults who have never received treatment for their infection.
- Trial name
- NCT07202546
- Testing
- VH4524184, Emtricitabine (FTC) and tenofovir alafenamide (TAF) Fixed Dose Combination (FDC) tablets, Dolutegravir / Lamivudine (DTG/3TC)
- Where
- 123 sites in United States, Argentina and 12 more
- Volunteers
- 186 people
- Sponsor
- ViiV Healthcare
HIV-associated Tuberculosis
Pharmacokinetics and Safety of Double-dose Dolutegravir When Used With Rifapentine for HIV-associated Tuberculosis
A5406 hypothesized that dolutegravir (DTG) 50 mg taken twice daily provides adequate exposures to maintain viral suppression when dosed with rifapentine (RPT) 1200 mg for HIV-associated tuberculosis (TB).
- Trial name
- NCT05630872
- Testing
- Dolutegravir (DTG) 50 mg orally BID (~12 hours apart) plus TDF/3TC, DTG 50 mg orally QD plus TDF/3TC, 2HPZM
- Where
- 4 sites in South Africa, Thailand
- Volunteers
- 30 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV
Immediate Initiation of Antiretroviral Therapy During "Hyperacute" HIV Infection
The purpose of this study is to identify and provide immediate antiretroviral therapy to a cohort of HIV-infected individuals with very early HIV infection (estimated date of infection within the last 90 days).
- Trial name
- DGVTAF (NCT02656511)
- Testing
- Dolutegravir, Emtricitabine/Tenofovir
- Where
- United States
- Volunteers
- 74 people
- Sponsor
- University of California, San Francisco
HIV Infections
A Study to Investigate the Safety and PK of VH4770359 in Healthy Participants
VH4770359 (also known as GSK4770359) is an antiretroviral compound. This first-in-human study aims to evaluate the safety, tolerability, and pharmacokinetics (PK) of orally administered VH4770359 in healthy participants.
- Trial name
- NCT07525544
- Testing
- VH4770359, Midazolam
- Where
- United States
- Volunteers
- 214 people, healthy volunteers welcome
- Sponsor
- 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