Clinical trials: sponsored by 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 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
Human Immunodeficiency Virus (HIV)-1 Infection, HIV-1 Subtype A6 Infection
Long-Acting Cabotegravir and Rilpivirine in People Living With HIV-1 Subtype A6: A Real-World Retrospective Study
This study evaluates the real-world effectiveness and safety of a long-acting injectable HIV treatment consisting of cabotegravir and rilpivirine in people living with HIV-1.
- Conditions
- Human Immunodeficiency Virus (HIV)-1 Infection, HIV-1 Subtype A6 Infection, HIV-1 Subtype B Infection, Virologically Suppressed HIV-1 Infection Receiving Long-Acting Antiretroviral Therapy
- Trial name
- LACRIS (NCT07370649)
- Testing
- Cabotegravir Plus Rilpivirine Long-Acting Injectable
- Where
- 7 sites in Czechia, Germany and 1 more
- Volunteers
- 250 people
- Sponsor
- Pomeranian Medical University Szczecin
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
A Study of the Safety, Tolerability, and Pharmacokinetics of Dolutegravir in Neonates Exposed to HIV-1
The purpose of this study was to evaluate the safety, tolerability, and pharmacokinetics (PK) of dolutegravir (DTG) in infants born to mothers living with HIV-1.
- Trial name
- NCT05406583
- Testing
- Dolutegravir 0.5 mg/kg liquid suspension (starts at 0-5 days of life), Dolutegravir 5 mg Dispersible Tablets (single doses), Dolutegravir 5 mg Dispersible Tablets (chronic dose)
- Where
- 15 sites in United States, South Africa and 1 more
- Volunteers
- 96 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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-1 Infection
Cartography of Virologic Reservoir Related to Antiretroviral Concentrations in HIV-1 Chronic Patients Treated by a First Line Treatment Containing Dolutegravir and Associated Nucleoside / Nucleotide Reverse Transcriptase Inhibitors Backbone
The main objective of the study is to characterize the diffusion of dolutegravir and associated backbone (abacavir/lamivudine or tenofovir/emtricitabine) in HIV-1 chronic patients in the main putative reservoirs, namely inguinal…
- Trial name
- DOLUVOIR (NCT04133012)
- Testing
- Samplings
- Where
- 8 sites in France
- Volunteers
- 20 people
- Sponsor
- ANRS, Emerging Infectious Diseases
Human Immunodeficiency Virus, Lipohypertrophy
Evaluation of Raltegravir Plus Maraviroc Therapy in Controlled HIV Patients Presenting With Lipohypertrophy
Evaluation of antiretroviral therapy combining Raltegravir and Maraviroc in patients with virological success, presenting with clinical lipohypertrophy.
- Trial name
- ROCnRAL (NCT01420523)
- Testing
- Raltegravir-Maraviroc
- Where
- France
- Volunteers
- 48 people
- Sponsor
- ANRS, Emerging Infectious Diseases
HIV, Substance Use Disorder (SUD)
Long-acting Cabotegravir Injectable Pre-exposure Prophylaxis for People Who Inject Drugs
The goal of this study is to determine the feasibility and impact of delivering long-acting injectable cabotegravir HIV pre-exposure prophylaxis and suite of support services to adults who inject non-prescription drugs who are…
- Conditions
- HIV, Substance Use Disorder (SUD), Injection Drug Use
- Trial name
- ASCEND (NCT07199335)
- Testing
- APRETUDE (cabotegravir)
- Where
- 2 sites in United States
- Volunteers
- 100 people
- Sponsor
- Massachusetts General Hospital
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
HIV Infections With Multi Drug Resistant Virus
Safety and Pharmacokinetics Evaluation of Fostemsavir + (OBT) in HIV-1 Infected Children and Adolescents Who Are Failing Their cART and Have Dual- or Triple-class Antiretroviral Resistance
In the SHIELD study, the study sponsor seeks to assess safety, PK and antiviral activity for children and adolescents with dual or triple class resistance.
- Trial name
- NCT04648280
- Testing
- Fostemsavir
- Where
- 8 sites in United States, Brazil and 1 more
- Volunteers
- 60 people
- Sponsor
- PENTA Foundation
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
ALIGN: A Non-randomised Study Delivering Injectable Lenacapavir for HIV Prevention Within a Pre-exposure Prophylaxis (PrEP) Choice Context in Cape Town, South Africa.
The ALIGN study will evaluate the delivery of injectable Lenacapavir (LEN), a long-acting injectable formulation for HIV pre-exposure prophylaxis (PrEP), amongst adolescents and young people (aged 15-35 years) living within the…
- Trial name
- ALIGN (NCT07390409)
- Testing
- Lenacapavir Injection, Cabotegravir (CAB) LA, Tenofovi-Emtricitabine (TDF/FTC) tablet
- Where
- South Africa
- Volunteers
- 3,700 people, healthy volunteers welcome
- Sponsor
- Desmond Tutu HIV Foundation
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
More Options for Children and Adolescents (MOCHA): Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in HIV-Infected Children and Adolescents
The purpose of this study was to determine the dosage for oral cabotegravir (CAB) and long-acting cabotegravir (CAB LA) and long-acting rilpiverine (RPV LA) and evaluate the safety, acceptability, tolerability, and…
- Trial name
- MOCHA (NCT03497676)
- Testing
- Oral Cabotegravir (CAB), Oral Rilpivirine (RPV), Long-Acting Injectable Cabotegravir (CAB LA)
- Where
- 19 sites in United States, Botswana and 3 more
- Volunteers
- 168 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections, Opioid Use
Optimizing CAB-LA as PrEP for Women Who Inject Drugs
The goal of this study is to elicit information crucial for designing strategies to support engagement in cabotegravir, a long-acting injectable form of pre-exposure prophylaxis (PrEP) to reduce HIV risk among women who inject…
- Conditions
- HIV Infections, Opioid Use, Trauma, Psychological
- Trial name
- NCT05799339
- Where
- United States
- Volunteers
- 144 people
- Sponsor
- Alexis Roth