Clinical trials: sponsored by ViiV Healthcare
- Lead sponsor (exact) ViiV Healthcare
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
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 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 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
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
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 Infections
Pharmacokinetics, Safety, Tolerability of Dolutegravir/Rilpivirine in Pediatrics
The purpose of this study is to provide data on the pharmacokinetic (PK), safety, tolerability, efficacy and acceptability of this fixed dose combination (FDC) single tablet 2-drug regimen for virologically suppressed (HIV-1 RNA…
- Trial name
- NCT05674656
- Testing
- Dolutegravir/Rilpivirine FDC
- Where
- 8 sites in United States
- Volunteers
- 20 people
- Sponsor
- ViiV Healthcare
Infection, Human Immunodeficiency Virus, HIV Infections
Study Of An Investigational Regimen Including FDA Approved HIV Drugs In HIV-Infected Pediatric Subjects
This is a 48-week study to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of an investigational regimen including FDA approved HIV drugs in HIV-infected pediatric subjects, ages 4 weeks to < 2 years…
- Trial name
- NCT00071760
- Testing
- GW433908, ritonavir
- Where
- 15 sites in United States, Argentina and 5 more
- Volunteers
- 59 people
- Sponsor
- ViiV Healthcare
Infection, Human Immunodeficiency Virus, HIV Infections
Dolutegravir Expanded Access Study
ING114916 is an open-label, multi-center, expanded access (EAP) study
- Trial name
- DEAP (NCT01536873)
- Testing
- Dolutegravir
- Where
- 74 sites in United States, Austria and 7 more
- Volunteers
- 200 people
- Sponsor
- ViiV Healthcare
Human Immunodeficiency Virus
An Open Label Pharmacokinetic, Safety And Efficacy Study Of Maraviroc In Combination With Background Therapy For The Treatment Of HIV-1 Infected, CCR5 -Tropic Children
The primary purpose of this study is to determine the pharmacokinetic properties (what the body does to maraviroc) and to determine a suitable dosing schedule of maraviroc in HIV-1 infected children and adolescents.
- Trial name
- NCT00791700
- Testing
- Maraviroc
- Where
- 41 sites in United States, Brazil and 7 more
- Volunteers
- 103 people
- Sponsor
- ViiV Healthcare
CHRONIC HEPATITIS B
A Trial To Study The Effect Of Lamivudine In Adult Patients Who Suffer From Chronic Hepatitis B Alone
The efficacy of lamivudine in Hepatitis Be Antigen (HBeAg) positive Asian patients of chronic hepatitis has been well established.The evidence in HBeAg negative patients is limited.
- Trial name
- NCT00354653
- Testing
- LAMIVUDINE
- Where
- Iran
- Volunteers
- 100 people
- Sponsor
- ViiV Healthcare
Infection, Human Immunodeficiency Virus I
PRJ2203: Dolutegravir Post Authorization Safety Study (PASS)
Dolutegravir (DTG) is recommended for both treatment-naïve and treatment-experienced, HIV infected adults and paediatric subjects aged 12 years and older and weighing at least 40 kg.
- Trial name
- NCT03327740
- Testing
- DTG based ARV regimen with ABC, DTG based ARV regimen without ABC, RAL or EGV based ARV regimens with ABC
- Volunteers
- 1 people
- Sponsor
- ViiV Healthcare
CCR5-tropic HIV-1 Infection
Safety And Efficacy Of Maraviroc In Patients For HIV Patients (Regulatory Post Marketing Commitment Plan)
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors…
- Trial name
- NCT00864474
- Testing
- CELSENTRI® Tablets
- Volunteers
- 68 people
- Sponsor
- ViiV Healthcare
HIV Infections
Drug Exposure Registry for GSK2248761, an Investigational NNRTI
The World Health Organization has estimated that as many as 10% of the population worldwide may at some point experience at least one seizure. The percentage with active epilepsy is from 0.4% to 1%.
- Trial name
- NCT01458132
- Volunteers
- 19 people
- Sponsor
- ViiV Healthcare
HIV Infections
Multicenter Pilot Study To Define The Marker As An Alternate For Tropism Assay
The purpose of this pilot study is to determine whether there is a correlation between viral load reduction (at Day 4, 7 or 14) following a short course (14 days) of Maraviroc added to a failing regimen, and the R5 result of the…
- Trial name
- NCT00496782
- Testing
- maraviroc, Trofile Assay and HIV RNA quantification assay
- Where
- 10 sites in United States, Canada
- Volunteers
- 16 people
- Sponsor
- ViiV Healthcare
Infection, Human Immunodeficiency Virus I
ZIAGEN® Post-marketing Surveillance
An open label, multi-centre, non-interventional post-marketing surveillance (PMS) to monitor the safety and efficacy of ZIAGEN® administered in Korean patients according to the prescribing information.
- Trial name
- NCT01205243
- Testing
- ZIAGEN®
- Where
- South Korea
- Volunteers
- 671 people
- Sponsor
- ViiV Healthcare
Infection, Human Immunodeficiency Virus
PENTA Fosamprenavir Study
Twice daily fosamprenavir, in combination with low dose ritonavir (FPV/RTV BID), is indicated for the treatment of HIV-infected adults, adolescents and children of 6 years of age and above for use in combination with other…
- Trial name
- NCT01077635
- Testing
- Exposure to licensed dose of FPV (+/- 20% of 18mg/kg BID + RTV)
- Volunteers
- 1 people
- Sponsor
- ViiV Healthcare
Infection, Human Immunodeficiency Virus I, HIV Infection
Observational Study Of A Protease Inhibitor (PI) Containing Regimen In Subjects With PI Mutations Selected During Prior Treatment With GW433908 (Fosamprenavir)
This study will assess the efficacy of subsequent protease inhibitor (PI)-containing therapy in subjects who have acquired HIV-1 protease mutations whilst receiving a GW433908 (fosamprenavir)-containing regimen.
- Trial name
- NCT00242840
- Testing
- No intervention; Observational study
- Where
- 7 sites in United States, Italy
- Volunteers
- 20 people
- Sponsor
- ViiV Healthcare