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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2017 by Gilead Sciences
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT02858401
First received: July 26, 2016
Last updated: April 17, 2017
Last verified: April 2017
  Purpose
The primary objectives of this study are to evaluate the safety and tolerability of a 6-dose regimen of vesatolimod (formerly GS-9620) (at 1 mg, 2 mg, and 4 mg dose levels) 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.

Condition Intervention Phase
HIV-1 Infection
Drug: Vesatolimod
Drug: Placebo
Drug: ARV regimen
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Incidence of treatment-emergent serious adverse events (SAEs) and all treatment-emergent adverse events [ Time Frame: Up to 157 days ]
  • Maximum change from baseline in plasma log10 HIV-1 RNA at any postdose timepoint [ Time Frame: Up to Day 81 (Cohorts 1 to 3) or up to Day 134 (Cohort 4) ]

Secondary Outcome Measures:
  • Change from baseline in plasma log10 HIV-1 RNA at post-baseline visits [ Time Frame: Up to 157 days ]
  • Proportion of participants with plasma HIV-1 RNA > 50 copies/mL at any postdose timepoint [ Time Frame: Up to Day 81 (Cohorts 1 to 3) or up to Day 134 (Cohort 4) ]
  • Change in single copy assay (SCA) from predose to 2 days postdose [ Time Frame: Predose to 2 days postdose ]
  • Change in cell-associated HIV-1 RNA from predose to 2 days postdose [ Time Frame: Predose to 2 days postdose ]
  • Change from baseline in the HIV latent reservoirs (Cohort 4 only) [ Time Frame: Up to Day 134 ]

Estimated Enrollment: 32
Actual Study Start Date: January 29, 2015
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vesatolimod 1 mg (Cohort 1)
Vesatolimod 1 mg for 71 days, while continuing their existing ARV regimen
Drug: Vesatolimod
Tablet(s) administered orally once every 2 weeks
Other Name: GS-9620
Drug: ARV regimen
Participants' current ARV regimen must be used in accordance with their prescribing information and may include the following: nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs), raltegravir, dolutegravir, rilpivirine, and maraviroc.
Experimental: Vesatolimod 2 mg (Cohort 2)
Vesatolimod 2 mg for 71 days, while continuing their existing ARV regimen
Drug: Vesatolimod
Tablet(s) administered orally once every 2 weeks
Other Name: GS-9620
Drug: ARV regimen
Participants' current ARV regimen must be used in accordance with their prescribing information and may include the following: nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs), raltegravir, dolutegravir, rilpivirine, and maraviroc.
Experimental: Vesatolimod 4 mg (Cohort 3)
Vesatolimod 4 mg for 71 days, while continuing their existing ARV regimen
Drug: Vesatolimod
Tablet(s) administered orally once every 2 weeks
Other Name: GS-9620
Drug: ARV regimen
Participants' current ARV regimen must be used in accordance with their prescribing information and may include the following: nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs), raltegravir, dolutegravir, rilpivirine, and maraviroc.
Experimental: Vesatolimod 6 mg (Cohort 4)
Vesatolimod 6 mg for 127 days, while continuing their existing ARV regimen
Drug: Vesatolimod
Tablet(s) administered orally once every 2 weeks
Other Name: GS-9620
Drug: ARV regimen
Participants' current ARV regimen must be used in accordance with their prescribing information and may include the following: nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs), raltegravir, dolutegravir, rilpivirine, and maraviroc.
Placebo Comparator: Placebo (Cohorts 1-4)
Placebo for 71 or 127 days, while continuing their existing ARV regimen
Drug: Placebo
Tablet(s) administered orally once every 2 weeks
Drug: ARV regimen
Participants' current ARV regimen must be used in accordance with their prescribing information and may include the following: nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs), raltegravir, dolutegravir, rilpivirine, and maraviroc.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key 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 ≥ 60 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.
  • No documented history of resistance to any components of the current ARV regimen
  • Availability of a fully active alternative ARV regimen, in the opinion of the Investigator, in the event of discontinuation of the current ARV regimen with development of resistance.
  • Hgb ≥ 11.5 g/dL (males) or ≥ 11 g/dL (females)
  • White blood cells (WBC) ≥ 2,500 cells/μL
  • Platelets ≥ 125,000/mL
  • Absolute neutrophil count (ANC) ≥ 1000 cells/μL
  • CD4 count ≥ 300 cells/μL
  • Albumin ≥ 3.9 g/dL
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2 × upper limit of the normal range (ULN)
  • Estimated glomerular filtration rate ≥ 60 mL/min
  • No autoimmune disease

Key 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 < 100 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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02858401

Locations
United States, California
Mills Clinical Research Recruiting
Los Angeles, California, United States, 90069
Contact: Anthony Mills, MD    310-550-2271    tmills@tonymillsmd.com   
UCSD Antiviral Research Center (AVRC) Recruiting
San Diego, California, United States, 92103
Contact: Constance A Benson, MD    619-543-8080    cbenson@ucsd.edu   
United States, Ohio
Ohio State University Infectious Diseases Research Recruiting
Columbus, Ohio, United States, 43210
Contact: Michael F. Para, MD    614-293-5282    para.1@osu.edu   
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Sharon Anne Riddler, MD    412-383-1741    riddler@pitt.edu   
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Gilead Study Director Gilead Sciences
  More Information

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02858401     History of Changes
Other Study ID Numbers: GS-US-382-1450
Study First Received: July 26, 2016
Last Updated: April 17, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

ClinicalTrials.gov processed this record on May 23, 2017