HIV-1-infection Clinical Trial
Official title:
A Phase 2 Study to Evaluate the Efficacy of GS-9131 Functional Monotherapy in HIV-1-Infected Adults Failing a Nucleos(t)Ide Reverse Transcriptase Inhibitor-Containing Regimen With Nucleos(t)Ide Reverse Transcriptase Inhibitor Resistant Virus
The primary objective of this study is to evaluate the short-term antiviral potency of GS-9131 functional monotherapy compared to placebo-to-match (PTM) GS-9131, each administered once daily with the existing failing antiretroviral (ARV) regimen as demonstrated by the proportion of participants achieving human immunodeficiency virus ribonucleic acid (HIV-1 RNA) > 0.5 log10 decreases from baseline after up to 14 days of therapy in HIV-1 positive, ARV treatment experienced adult participants with nucleos(t)ide resistant virus. This is a two-part study. Part 1 consists of three cohorts: 2 Sentinel Cohorts and 1 Randomized Cohort. Eligible participants from Part 1 will proceed to Part 2 followed by an optional open-label extension.
n/a
| 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 |
NCT06282783 -
Studying Topiramate for Re-Activating the HIV-1 Reservoir
|
Phase 1/Phase 2 | |
| 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 | |
| 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 | |
| Withdrawn |
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
|
||
| 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 | |
| Completed |
NCT04388904 -
Rapid Reinitiation of a Single Tablet Antiretroviral Therapy Using Symtuza® in HIV-1 Infected Treatment-Experienced Patients Off Therapy. (ReSTART)
|
Phase 4 | |
| Completed |
NCT04568239 -
Impact of M184V on the Virological Efficacy to 3TC/DTG (LAMRES)
|
||
| Not yet recruiting |
NCT04311944 -
Early Fast-Track Versus Standard Care for Persons With HIV Initiating TLD
|
N/A | |
| Not yet recruiting |
NCT04513496 -
Telemedicine in HIV Care in Buenos Aires
|
||
| Not yet recruiting |
NCT04311957 -
Continuation of Protease-Inhibitor Based Second-Line Therapy vs. Switch to B/F/TAF in Virologically Suppressed Adults
|
Phase 4 | |
| Completed |
NCT03998176 -
Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in HIV-1 Infected Patients With Active Illicit Substance usE
|
Phase 4 |