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
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 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
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
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
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, 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)
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
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 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
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
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 Infection
ODYSSEY (PENTA 20)
A new anti-HIV medicine (Dolutegravir) combined with 2 currently used anti-HIV medicines is non-inferior to the standard combination of medicines used in terms of efficacy and better in terms of toxicity.
- Trial name
- NCT02259127
- Testing
- Dolutegravir, Standard of Care
- Where
- 28 sites in Germany, Portugal and 6 more
- Volunteers
- 792 people
- Sponsor
- PENTA Foundation
HIV-1-infection, Multi-Antiviral Resistance
Italian Registry of HIV-1 Infected Patients With Drug-RESistant Virus to Reverse Transcriptase Inhibitors, InteGrasE and Viral Protease.
The PRESTIGIO Registry is an Observational, prospective, multicentre study that includes patients, regularly followed by Italian Infectious Disease Centres, with HIV-1 infection and documented resistance to the 4 classes of…
- Trial name
- PRESTIGIO (NCT04098315)
- Testing
- REGISTER CREATION
- Where
- Italy
- Volunteers
- 300 people
- Sponsor
- Castagna Antonella
HIV Infections, Hepatitis B
Antiretroviral Pregnancy Registry (APR): Multi-sponsor Registry to Detect Any Major Teratogenic Effect Involving Any of the Registry Drugs When Administered to Pregnant People.
The purpose of the Antiretroviral Pregnancy Registry (Registry) is to detect any major teratogenic effect involving any of the Registry drugs when administered to pregnant people.
- Trial name
- APR (NCT00404989)
- Where
- United States
- Volunteers
- 24,258 people
- Sponsor
- Syneos Health