HIV-1-infection Clinical Trial
Official title:
Phase I/II Study of the Safety, Tolerability, Acceptability, and Pharmacokinetics of Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in Virologically Suppressed Children Living With HIV-1, Two to Less Than 12 Years of Age
The purpose of the study is to evaluate the pharmacokinetics (PK), safety, tolerability, and acceptability of a long-acting injectable Cabotegravir and Rilpivirine in Virologically Suppressed Children Living with HIV-1, Two to Less Than 12 Years of Age
This is a Phase I/II, multicenter, open-label, non-comparative study to evaluate the safety, tolerability, acceptability, and PK of oral CAB and oral RPV followed by long-acting injectable CAB (CAB LA) and long-acting injectable RPV (RPV LA) to propose the weight-band dosing in virologically suppressed children living with HIV-1 aged two to less than 12 years. The study will also assess the long-acting injectable regimen with and without an oral lead-in period in the same study population. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03940521 -
Bioclinical Evaluation of 2 Biomarkers of Aviremic HIV-1 in CD4+ T Cells of Adults Undergoing Treatment
|
||
| Completed |
NCT03227731 -
Immediate or Deferred Pre-exposure Prophylaxis for HIV Prevention: Safe Options for Pregnant and Lactating Women
|
Phase 2/Phase 3 | |
| Completed |
NCT03570918 -
MGD014 in HIV-Infected Individuals on Suppressive Antiretroviral Therapy
|
Phase 1 | |
| Not yet recruiting |
NCT06336434 -
CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT04022967 -
ANRS 12372 MODERATO Study
|
Phase 3 | |
| Not yet recruiting |
NCT06337032 -
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
|
Phase 4 | |
| Not yet recruiting |
NCT06282783 -
Studying Topiramate for Re-Activating the HIV-1 Reservoir
|
Phase 1/Phase 2 | |
| Completed |
NCT04711265 -
Antibody Response to Prophylactic QHPV Vaccine at 48 Months Among HIV-infected Girls and Boys
|
||
| Recruiting |
NCT03536234 -
Efficacy and Safety of GnRH Analogue Triptorelin for HIV-1 Reservoir Reduction in ART Treated HIV-1 Infected Patients
|
Phase 2 | |
| Completed |
NCT04340388 -
Contribution of Dolutegravir to Obesity and Cardiovascular Disease
|
Phase 4 | |
| Not yet recruiting |
NCT05769569 -
Safety and Efficacy of Neutralizing Antibodies and Vaccination for Induction of HIV Remission
|
Phase 1 | |
| Enrolling by invitation |
NCT05584397 -
Comparing Immune Activation and Latent HIV Reservoir Size Between People Living With HIV on Tenofovir-containing Versus NRTI-free ART
|
||
| Active, not recruiting |
NCT04388904 -
Rapid Reinitiation of a Single Tablet Antiretroviral Therapy Using Symtuza® in HIV-1 Infected Treatment-Experienced Patients Off Therapy. (ReSTART)
|
Phase 4 | |
| Not yet recruiting |
NCT04894357 -
Impact of V106I on Resistance to Doravirine
|
||
| Completed |
NCT04963712 -
Zadaxin and HIV-positive Patients With Immune Reconstitution Disorder
|
Early Phase 1 | |
| Not yet recruiting |
NCT04513496 -
Telemedicine in HIV Care in Buenos Aires
|
||
| Completed |
NCT04568239 -
Impact of M184V on the Virological Efficacy to 3TC/DTG (LAMRES)
|
||
| Not yet recruiting |
NCT04311957 -
Continuation of Protease-Inhibitor Based Second-Line Therapy vs. Switch to B/F/TAF in Virologically Suppressed Adults
|
Phase 4 | |
| Not yet recruiting |
NCT04311944 -
Early Fast-Track Versus Standard Care for Persons With HIV Initiating TLD
|
N/A | |
| Completed |
NCT03998176 -
Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in HIV-1 Infected Patients With Active Illicit Substance usE
|
Phase 4 |