A Study to Investigate the Use of VH3810109 With or Without Fostemsavir (FTR) to Reduce the Size and Activity of the Viral Reservoir in People Living With HIV
NCT07053384 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 107
Last updated 2026-03-24
Summary
This study investigates the use of VH3810109 with or without FTR to reduce the size and activity of the HIV viral reservoir in two sub-populations of people living with HIV: treatment-naïve adults (Population 1) and treatment-experienced adults currently taking a standard of care (SOC) integrase strand transfer inhibitor (INSTI)-based antiretroviral therapy (ART) regimen (Population 2).
Conditions
- HIV Infections
Interventions
- DRUG
-
SOC INSTI-based ART
A SOC INSTI-based ART regimen will be administered.
- BIOLOGICAL
-
VH3810109
VH3810109 will be administered.
- DRUG
-
Fostemsavir (FTR)
Fostemsavir will be administered.
Sponsors & Collaborators
-
ViiV Healthcare
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-07-10
- Primary Completion
- 2027-01-22
- Completion
- 2028-09-06
- FDA Drug
- Yes
Countries
- United States
- Belgium
- Denmark
- Netherlands
- Spain
- United Kingdom
Study Locations
More Related Trials
-
Fostemsavir Compassionate Use Named Patient Program for the Treatment of Human Immunodeficiency Virus 1 (HIV-1)
NCT04233047 ·Status: AVAILABLE
-
Effect of an Enfuvirtide-based Anti-HIV Drug Regimen on Latent HIV Reservoirs in Treatment Naive Adults
NCT00051831 ·Status: COMPLETED ·Phase: NA
-
Accelerated ART Initiation for PWHIV Who Are Out of Care
NCT06374758 ·Status: RECRUITING ·Phase: PHASE4
-
Research In Viral Eradication of HIV Reservoirs
NCT02336074 ·Status: COMPLETED ·Phase: PHASE2
-
Once-daily Antiretroviral Therapy in HIV-1 Infected Patients With CD4+ Cell Counts Below 100 Cells/Mcl
NCT00532168 ·Status: COMPLETED ·Phase: PHASE4
-
Safety and Effect on HIV Transcription of Vorinostat in Patients Receiving Suppressive Combination Anti-retroviral Therapy
NCT01365065 ·Status: UNKNOWN ·Phase: PHASE2
-
Study to Evaluate Switching From a Regimen of Two Nucleos(t)Ide Reverse Transcriptase Inhibitors (NRTI) Plus a Third Agent to a Fixed Dose Combination (FDC) of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF), in Virologically-Suppressed, HIV-1 Infected African American Participants
NCT03631732 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Assess Safety and Activity of Combination Therapy of VRC07-523LS and Vorinostat on HIV-infected Persons
NCT03803605 ·Status: COMPLETED ·Phase: PHASE1
-
Study of Enfuvirtide in HIV-Positive Subjects
NCT00086710 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Evaluate Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) in Virologically-Suppressed HIV-1 Infected Adults Harboring the Archived Isolated NRTI Resistance Mutation M184V/M184I
NCT02616029 ·Status: COMPLETED ·Phase: PHASE3
-
Second-line Therapy Antiretroviral in Patients Who Failed Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) - Based Regimens
NCT00627055 ·Status: COMPLETED ·Phase: PHASE4
-
Selection of Farnesoid X Receptor (FXR) Ligands on the Reactivation of Latent HIV Proviruses
NCT05219916 ·Status: TERMINATED ·Phase: NA
-
TMC125-TiDP35-C239 - Continued Access to Etravirine (ETR) in Treatment Experienced HIV-1 Infected Participants
NCT00980538 ·Status: COMPLETED ·Phase: PHASE3
-
Selective Estrogen Receptor Modulators to Enhance the Efficacy of Viral Reactivation With Histone Deacetylase Inhibitors
NCT03382834 ·Status: COMPLETED ·Phase: PHASE2
-
Switch Study to Evaluate F/TAF in HIV-1 Positive Participants Who Are Virologically Suppressed on Regimens Containing FTC/TDF
NCT02121795 ·Status: COMPLETED ·Phase: PHASE3
-
Registry to Assess Long-term Outcome in HIV Subjects Who Participated in Phase 2 and 3 Clinical Trials Involving Vicriviroc (Study P04999)
NCT00705419 ·Status: COMPLETED
-
A Study to Evaluate the Safety and Efficacy of Adding Enfuvirtide to Oral Highly Active Antiretroviral Therapy (HAART) in Human Immunodeficiency Virus (HIV) Patients With Prior Treatment Experience
NCT00487188 ·Status: COMPLETED ·Phase: PHASE4
-
CSP #512 - Options in Management With Anti-Retrovirals
NCT00050089 ·Status: COMPLETED ·Phase: NA
-
Observational Study in Patients With HIV Infection Type 1 After Switching to a Viramune®-Containing Therapy Regimen
NCT02191332 ·Status: COMPLETED
-
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
NCT06337032 ·Status: RECRUITING ·Phase: PHASE4
-
Tenofovir Disoproxil Fumarate in HIV-Infected Patients Who Have Not Had Success With Other Anti-HIV Drug Combinations
NCT00011089 ·Status: UNKNOWN ·Phase: NA
-
Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor (PI) and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) to a Fixed-dose Tablet Containing Emtricitabine/Rilpivirine/Tenofovir DF
NCT01252940 ·Status: COMPLETED ·Phase: PHASE3
-
Switching From Protease Inhibitor (PI) to Etravirine in HIV-1 Infected Subjects With Viremia Suppression
NCT01034917 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Fuzeon (Enfuvirtide) With an Integrase Inhibitor Plus Optimized Background in Treatment-Experienced HIV-1 Infected Patients
NCT00488059 ·Status: TERMINATED ·Phase: PHASE4
-
Effect of Dolutegravir Intensification on HIV-1 Reservoirs
NCT05351684 ·Status: COMPLETED ·Phase: PHASE2