Loading clinical trials...

Safety and Biological Activity of Vesatolimod in HIV-1 Infected, Virologically Suppressed Adults | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Safety and Biological Activity of Vesatolimod in HIV-1 Infected, Virologically Suppressed Adults

A Phase 1b, Randomized, Blinded, Placebo-Controlled Dose-Escalation Study of the Safety and Biological Activity of GS-9620 in HIV-1 Infected, Virologically Suppressed Adults

NCT02858401•Gilead Sciences

View on ClinicalTrials.gov

Summary

The primary objectives of this study are to evaluate the safety and tolerability of escalating, multiple doses of vesatolimod (formerly GS-9620) in HIV-1 infected virologically suppressed adults on antiretroviral therapy (ART) and to evaluate the virologic effect of vesatolimod as measured by changes in plasma HIV-1 RNA.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•HIV-1 infection
•Aged ≥ 18 years at Pre-baseline/Day -13
•On antiretroviral (ARV) treatment for ≥ 12 consecutive months prior to Pre-Baseline/Day -13
•* The following agents are allowed as part of the current ARV regimen: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc
•* The following agents are NOT allowed as part of the current ARV regimen: HIV protease inhibitors (including low dose ritonavir), cobicistat-containing regimens, elvitegravir, efavirenz, etravirine, and nevirapine
•* A change in ARV regimen ≥ 45 days prior to baseline/Day 1 for reasons other than virologic failure (eg, tolerability, simplification, drug-drug interaction profile) is allowed
•Plasma HIV-1 RNA \< 50 copies/mL at screening
•Documented plasma HIV-1 RNA levels \< 50 copies/mL (according to the local assay being used) for ≥ 12 months preceding the screening visit (measured at least twice using a licensed assay with a lower limit of quantitation of at least 40 copies/mL)
•* Unconfirmed virologic elevations of ≥ 50 copies/mL (transient detectable viremia, or "blip") prior to screening are acceptable. (If the lower limit of detection of the local HIV-1 RNA assay is \< 50 copies/mL, the plasma HIV-1 RNA level cannot exceed 50 copies/mL on two consecutive HIV-1 RNA tests)
•* If ART regimen is changed ≥ 60 days prior to Pre-Baseline/Day -13, plasma HIV-1 RNA \<50 copies/mL at Pre-baseline/Day -13 visit is required
+11 more criteria

Exclusion Criteria

•Hepatitis B surface antigen (HBsAg) positive
•* Positive anti-HBs antibody and negative HBsAg results are acceptable
•Hepatitis C antibody (HCVAb) positive
•* Positive anti-HCV antibody and negative HCV polymerase chain reaction (PCR) results are acceptable
•Documented history of pre-ART CD4 nadir \< 200 cells/µL
•* Unknown pre-ART CD4 nadir is acceptable
•A new AIDS-defining condition diagnosed within 90 days prior to screening
•Acute febrile illness within 35 days prior to pre-baseline/Day -13

Locations (8)

Mills Clinical Research

Los Angeles, California, United States

UCSD Antiviral Research Center (AVRC)

San Diego, California, United States

Midway Immunology & Research Center

Ft. Pierce, Florida, United States

Orlando Immunology Center Recruiting

Orlando, Florida, United States

Ohio State University Infectious Diseases Research

Columbus, Ohio, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Central Texas Clinical Research

Austin, Texas, United States

Peter Shalit, MD

Seattle, Washington, United States

Key Dates

Start Date

January 29, 2015

Primary Completion Date

February 14, 2019

Completion Date

February 14, 2019

Last Updated

February 21, 2020

Enrollment

ACTUAL participants

Conditions

HIV-1 Infection

Interventions

Vesatolimod

DRUG

Placebo

DRUG

ARV regimen

DRUG

Change in Body Weight and BMI in PWH with DOR/3TC/TDF Compared with INSTI

NCT06602622

HIVHIV Associate Weight Loss+4 more

View study

COMPLETEDPHASE4

Implementation of Out-of-HOspital Administration of the Long-Acting Cabotegravir+Rilpivirine

NCT06185452

HIV-1 Infection

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 21, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Safety and Biological Activity of Vesatolimod in HIV-1 Infected, Virologically Suppressed Adults

Inclusion Criteria

Exclusion Criteria

Change in Body Weight and BMI in PWH with DOR/3TC/TDF Compared with INSTI

Implementation of Out-of-HOspital Administration of the Long-Acting Cabotegravir+Rilpivirine

Clinical Research on the Use of Immune Checkpoint Inhibitors Combined With Chidamide for the Functional Cure of AIDS

Study to Assess the ART Impact on the Brain Outcomes. The ARBRE Study

Study to Evaluate Effects of Vorinostat and HXTC on Persistent HIV-1 Infection in HIV-Infected Subjects Started on Antiretroviral Therapy (ART)

Study for Evaluation of the Safety, Pharmacokinetics, and Antiviral Activity of UB-421 Subcutaneous Formulation Administered in HIV-1 Infected Treatment Naive Patients