Clinical trials: sponsored by ViiV Healthcare
HIV Infections
Long-term Follow-up of Long-acting Cabotegravir (CAB LA) for PrEP (Pre-exposure Prophylaxis) in Participants at Risk of Acquiring HIV (Human Immunodeficiency Virus)
The purpose of this study is long-term evaluation of long-acting injectable cabotegravir (CAB LA) for HIV pre-exposure prophylaxis (PrEP) in eligible participants who have completed DAIDS (Division of AIDS) sponsored studies HPTN…
- Trial name
- PALISADE (NCT06134362)
- Testing
- CAB LA
- Where
- 33 sites in Argentina, Botswana and 10 more
- Volunteers
- 2,998 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV Infections
First Time in Human Study of Long Acting VH4524184 Formulations
The purpose of this study is to identify 1 or more doses of parenterally administered VH4524184 that are safe, well tolerated and yield a PK drug exposure profile necessary to deliver a long-acting antiretroviral therapy for the…
- Trial name
- NCT06310551
- Testing
- Oral VH4524184, VH4524184 Formulation A SC, rHuPH20
- Where
- 5 sites in United States
- Volunteers
- 348 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, CAB >=400 mg/mL, CAB Formulation I
- Where
- 3 sites in United States
- Volunteers
- 214 people, healthy volunteers welcome
- 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
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 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
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, 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
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
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 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 Infection, Sexually Transmitted Infection
Duo: A Phase IIIb Individual-Level Randomized Controlled Trial of an Integrated Strategy
Individual-Level Randomized Controlled Trial of an Integrated Strategy of HIV pre-exposure prophylaxis (PrEP) and sexually transmitted infection (STI) post-exposure prophylaxis (PEP) for Young Men
- Trial name
- NCT07658976
- Testing
- HIV PrEP - choice of F/TDF, F/TAF, or CAB-LA, STI PEP - Doxycycline as Doxy-PEP, 3P mHealth package
- Where
- 5 sites in United States, Argentina and 2 more
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- HIV Prevention Trials Network
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 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
Injectable Cabotegravir Compared to TDF/FTC For PrEP in HIV-Uninfected Men and Transgender Women Who Have Sex With Men
This study will evaluate the safety and efficacy of the injectable drug cabotegravir (CAB LA), for pre-exposure prophylaxis (PrEP) in HIV-uninfected cisgender men and transgender women who have sex with men (MSM and TGW).
- Trial name
- NCT02720094
- Testing
- Cabotegravir Oral Tablet, TDF/FTC tablets, CAB LA
- Where
- 43 sites in United States, Argentina and 5 more
- Volunteers
- 4,570 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infection, HIV
#AWARE.HIV Europe: Supporting Healthcare Professionals to Find Undiagnosed HIV in European Hospitals: An Effectiveness-implementation Trial.
The #aware.hiv Europe study is a real-world, multicenter, stepped-wedge cluster randomized, effectiveness-implementation trial designed to evaluate whether the introduction of dedicated HIV teams in hospitals can improve HIV…
- Conditions
- HIV Infection, HIV, Stigma, Education
- Trial name
- #aware hiv (NCT06900829)
- Testing
- HIV team implementation
- Where
- 28 sites in Belgium, France and 8 more
- Volunteers
- 5,200 people, healthy volunteers welcome
- Sponsor
- Casper Rokx
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