Clinical trials: sponsored by ViiV Healthcare
HIV-1-infection
B/F/TAF to DTG/3TC Switch Study
OBJECTIVE: To assess the efficacy and safety of switch to dolutegravir and lamivudine (DTG/3TC) single tablet regimen from bictegravir, emtricitabine and tenofovir alafenamide (B/F/TAF) in persons living with HIV aged 60 years…
- Trial name
- NCT06444620
- Testing
- DTG/3TC
- Where
- 2 sites in Kenya
- Volunteers
- 197 people
- Sponsor
- University of Nairobi
HIV Infection
Reaching Persons With HIV Who Are Out of Care Through Expedited Access to Long-Acting Injectable Antiretroviral Therapy - The RELAI Study
Purpose: The purpose of this study is to evaluate the acceptability of field-based long acting cabotegravir/rilpivirine (LA-CAB/RPV) among people with HIV (PWH) who are out of care.
- Trial name
- NCT07895823
- Testing
- Field-based LA-CAB/RPV
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of North Carolina, Chapel Hill
HIV Infections
Efficacy, Safety and Tolerability Study of Long-acting Cabotegravir Plus Long-acting Rilpivirine (CAB LA + RPV LA) in Human-immunodeficiency Virus-1 (HIV-1) Infected Adults
This Antiretroviral Therapy as Long Acting Suppression every 2 Months (ATLAS-2M) study is designed to demonstrate the non-inferior antiviral activity and safety of CAB LA + RPV LA administered every 8 weeks (Q8W) compared to CAB…
- Trial name
- ATLAS-2M (NCT03299049)
- Testing
- Cabotegravir Tablets, Rilpivirine Tablets, Cabotegravir Injectable Suspension
- Where
- 119 sites in United States, Argentina and 11 more
- Volunteers
- 1,049 people
- Sponsor
- ViiV Healthcare
HIV Infections
A Study to Investigate Pharmacokinetics (PK), Safety, and Tolerability of VH4367310 in Healthy Adult Participants
This study evaluates the PK, safety, and tolerability of a single increasing dose of VH4367310, a cabotegravir (CAB) prodrug, when administered intramuscularly in healthy adult participants 18 to 55 years of age.
- Trial name
- NCT07818915
- Testing
- VH4367310
- Where
- 2 sites in United States
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV Infections
A Study to Assess the Safety and Pharmacokinetics of a Human Monoclonal Antibody (VH4527079) in Healthy Adults and Persons With HIV
This study evaluates the safety, tolerability, and pharmacokinetics (PK) of a single dose administration of VH4527079 by subcutaneous (SC) injection or by intravenous (IV) infusion in healthy adult participants and multiple dose…
- Trial name
- NCT06652958
- Testing
- VH4527079
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV, HIV Infections
A Study to Evaluate the Efficacy, Safety, and Tolerability of Using an Oral Once-daily 2 Drug Regimen Compared to an Oral Once-daily 3 Drug Regimen for the Treatment of Human Immunodeficiency Virus (HIV)-1 in Adults Who Have Not Previously Taken Antiretroviral Therapy
This study will compare safety, efficacy, participant reported outcomes and implementation outcomes of a fixed dose combination (FDC) of a two-drug regimen dolutegravir (DTG) plus lamivudine (3TC) and a three-drug regimen FDC of…
- Trial name
- VOGUE (NCT05979311)
- Testing
- Dolutegravir, Lamivudine, Bictegravir
- Where
- 64 sites in Argentina, Belgium and 15 more
- Volunteers
- 463 people
- Sponsor
- ViiV Healthcare
Hiv
Pharmacist-led Intervention for Injectable HIV Treatment for Women With Health-related Social Needs
This study addresses real-world use of long-acting injectable cabotegravir/rilpivirine (CAB/RPV LA) by evaluating implementation and clinical outcomes of a pharmacist-led collaborative drug therapy management model (CDTM+) that…
- Trial name
- NCT06411223
- Testing
- Collaborative drug therapy management model, Cabotegravir/Rilpivirine
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Yale University
HIV Infections
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a New Formulation of Cabotegravir Long-Acting Administered Intramuscularly in a 4-month Dosing Interval (Q4M)
This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a new formulation of Cabotegravir (CAB) dosed every 4-months (Q4M) for pre-exposure prophylaxis (PrEP) in participants at risk of HIV-1 acquisition.
- Trial name
- NCT06741397
- Testing
- CAB LA, New formulation of CAB LA
- Where
- 27 sites in United States, Puerto Rico
- Volunteers
- 229 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV-1 Infected Adults With Controlled Viremia
Long Acting Cabotegravir Plus Rilpivirine in People Living With HIV-1 Aged ≥ 60 Years for 24 Months.
People Living with HIV-1 (PLHIV) are an important group of patients attending their specialist's and continue growing thanks to efficacy antiretroviral treatment (ART), allowing them to stabilize the HIV-infection and to live a…
- Trial name
- LOVER60 (NCT06646562)
- Testing
- Cabotegravir LA + Rilpivirine LA
- Where
- 8 sites in Spain
- Volunteers
- 120 people
- Sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
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
A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1
This study will assess how effective, safe, and long-lasting a long-acting antiretroviral therapy (ART) using CAB LA + RPV LA is for people with HIV who still have detectable virus levels despite being on oral ART.
- Trial name
- CROWN (NCT06694805)
- Testing
- CAB LA + RPV LA, Oral ART
- Where
- 85 sites in United States, Argentina and 6 more
- Volunteers
- 326 people
- Sponsor
- ViiV Healthcare
HIV Infections
A Study to Investigate Cabotegravir Ultra Long-Acting (CAB ULA) Plus Rilpivirine Ultra Long-Acting (RPV ULA) in Adults and Adolescents With HIV Who Are Virologically Suppressed
This study compares the efficacy, safety and tolerability of CAB ULA and RPV ULA administered with CAB long acting (LA) and RPV LA administered in adults and adolescents with HIV who are virologically suppressed on…
- Trial name
- NCT07650916
- Testing
- CAB ULA, RPV ULA, CAB LA
- Where
- 108 sites in United States, Argentina and 8 more
- Volunteers
- 564 people
- Sponsor
- ViiV Healthcare
HIV Infections
A Study to Investigate the Use of VH3810109 With or Without Fostemsavir (FTR) to Reduce the Size and Activity of the Viral Reservoir in People Living With HIV
This study investigates the use of VH3810109 with or without FTR to reduce the size and activity of the HIV viral reservoir in two sub-populations of people living with HIV: treatment-naïve adults (Population 1) and…
- Trial name
- ENTRANCE (NCT07053384)
- Testing
- VH3810109, Fostemsavir (FTR), SOC INSTI-based ART
- Where
- 41 sites in United States, Belgium and 4 more
- Volunteers
- 107 people
- Sponsor
- ViiV Healthcare
HIV
SEARCH CAB LA Dynamic Choice HIV Prevention Study Extension
The overall purpose of this SEARCH CAB-LA (Cabotegravir Injectable Suspension) randomized extension study is to determine if adding the option of CAB-LA as a prevention choice using a person-centered dynamic choice HIV (human…
- Trial name
- NCT05549726
- Testing
- Cabotegravir Injectable Suspension, Dynamic Choice Delivery Model, Standard of Care
- Where
- 2 sites in Kenya, Uganda
- Volunteers
- 984 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
HIV-1-infection
2DR Versus 3DR in a Prospective Randomized Controlled Switch Trial
The aim of this study is to monitor virological and immunological markers in participants who are switching from a classic triple drug regimen (3DR) to dual therapy (2DR).
- Trial name
- 2DR (NCT04553081)
- Testing
- Dual versus triple therapy in treatment of HIV-1 infection.
- Where
- Belgium
- Volunteers
- 134 people
- Sponsor
- University Hospital, Ghent
HIV-1-infection
Dolutegravir/Lamivudine in Treatment-Naïve Pregnant Women
Protocol Number: FH-94 Study Objetives: Primary: To evaluate the virological response to Dolutegravir/Lamivudine in naive pregnant women with HIV who are starting antiretroviral therapy and vertical transmission in exposed…
- Trial name
- PREDUAL (NCT07616739)
- Testing
- Dolutegravir/Lamivudine 50 MG-300 MG Oral Tablet [DOVATO], TDF/XTC or TAF/FTC plus Dolutegravir (XTC stand for lamivudine OR emtricitabine)
- Where
- 10 sites in Argentina, Brazil
- Volunteers
- 210 people
- Sponsor
- Fundación Huésped
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
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 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
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