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Evaluate the Safety and Efficacy of Vesatolimod in Antiretroviral Treated HIV-1 Infected Controllers

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ClinicalTrials.gov Identifier: NCT03060447
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : June 6, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
The primary objective of this study is to evaluate the safety and tolerability of a 10-dose regimen of vesatolimod in HIV-1 infected controllers on antiretroviral treatment (ART) and during analytical treatment interruption (ATI) following vesatolimod dosing.

Condition or disease Intervention/treatment Phase
HIV-1 Infection Drug: Vesatolimod Drug: Vesatolimod Placebo Drug: ART Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1b, Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of GS-9620 in Antiretroviral Treated HIV-1 Infected Controllers
Actual Study Start Date : May 9, 2017
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Vesatolimod

Period 1: Participants will receive up to 10 doses of vesatolimod. Participants will continue to take their prescribed ART during this period.

Period 2: All participants will discontinue ART and be monitored for rebound in HIV-1 plasma viremia.

Drug: Vesatolimod
6 mg dose administered as three 2 mg tablets orally every 14 days
Other Name: GS-9620

Drug: ART
ART regimens administered in accordance with their Prescribing Information

Experimental: Vesatolimod placebo

Period 1: Participants will receive up to 10 doses of vesatolimod placebo. Participants will continue to take their prescribed ART during this period.

Period 2: All participants will discontinue ART and be monitored for rebound in HIV-1 plasma viremia.

Drug: Vesatolimod Placebo
Tablet administered orally once every 14 days

Drug: ART
ART regimens administered in accordance with their Prescribing Information




Primary Outcome Measures :
  1. Overall Safety Profile as Assessed by Percentage of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs) and all Treatment-Emergent Adverse Events. [ Time Frame: Up to 45 weeks plus 30 days ]

Secondary Outcome Measures :
  1. Virology: Changes in Plasma HIV-1 RNA and Cell Associated Viral RNA (CAVR) During the Dosing Period [ Time Frame: Up to 20 weeks ]
  2. Virology: Changes in Peripheral Blood Mononuclear Cell (PBMC) HIV-1 Reservoir Between Baseline and Following Vesatolimod Dosing [ Time Frame: Up to 45 weeks ]
  3. Virology: Changes in Total CD4+ T Cell Reservoirs [ Time Frame: Up to 45 weeks ]
  4. Virology: Time to Virologic Rebound and Plasma Viral Load Set-Point Following ATI [ Time Frame: Up to 25 weeks ]
  5. Virology: Peak HIV-1 Viral Load During Period 2 [ Time Frame: Up to 25 weeks ]
  6. Immunology/Pharmacodynamics: Changes in Serum/Plasma Cytokines [ Time Frame: Up to 45 weeks ]
  7. Immunology/Pharmacodynamics: Changes in Plasma Kynurenine/ Tryptophan (K/T) [ Time Frame: Up to 45 weeks ]
  8. Immunology/Pharmacodynamics: Changes in mRNA of Interferon-Stimulated Genes (ISGs) in Whole Blood [ Time Frame: Up to 45 weeks ]
  9. Immunology/Pharmacodynamics: Changes in Immune cell Activation [ Time Frame: Up to 45 weeks ]
  10. Immunology/Pharmacodynamics: Changes in HIV-1 Specific T cell Immune Responses [ Time Frame: Up to 45 weeks ]
  11. Immunology/Pharmacodynamics: Changes in the Frequency of Regulatory T cells [ Time Frame: Up to 45 weeks ]
  12. Immunology/Pharmacodynamics: Changes in the Quantity of HIV-Specific Antibodies [ Time Frame: Up to 45 weeks ]
  13. Immunology/Pharmacodynamics: Changes in the Quality (Effector Functionality) of HIV-Specific Antibodies [ Time Frame: Up to 45 weeks ]
  14. Immunology/Pharmacodynamics: Change in Plasma Inflammatory Markers [ Time Frame: Up to 45 weeks ]
  15. Pharmacokinetic (PK) Parameter: Cmax of Vesatolimod [ Time Frame: Up to 45 weeks ]
    Cmax is defined as maximum observed concentration of drug in plasma

  16. PK Parameter: Ctau of Vesatolimod [ Time Frame: Up to 45 weeks ]
    Ctau is defined as the observed drug concentration at the end of the dosing interval (tau)

  17. PK Parameter: AUCtau of Vesatolimod [ Time Frame: Up to 45 weeks ]
    AUCtau is defined as the area under the plasma concentration versus time curve over the dosing interval (tau)



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

Key Inclusion Criteria:

  • Plasma HIV-1 RNA levels <50 copies/mL at screening
  • Chronic HIV-1 infection (for ≥ 6 months) prior to ART initiation
  • Pre-ART Plasma HIV-1 RNA set point between 50 and ≤ 5,000 copies/mL measured within two years prior to ART initiation
  • On ART for ≥ 6 months prior to screening
  • Documented plasma HIV-1 RNA < 50 copies/mL for ≥ 6 months preceding the screening visit (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL). Unconfirmed virologic elevations of ≥ 50 copies/mL (transient detectable viremia, or "blip") prior to screening are acceptable.
  • No documented history of resistance to any components of the current ART regimen
  • Availability of a fully active alternative ART regimen, in the opinion of the Investigator, in the event of discontinuation of the current ART regimen with development of resistance.
  • Hemoglobin ≥ 11.5 g/dL (males) or ≥ 11 g/dL (females)
  • White Blood Cells ≥ 2,500 cells/μL
  • Platelets ≥ 125,000/mL
  • Absolute Neutrophil Counts ≥ 1000 cells/μL
  • CD4+ count ≥ 500 cells/μL
  • Alanine aminotransferase (ALT), aspartate aminotransferase (AST) or bilirubin ≤ 2 × upper limit of normal (ULN)
  • Estimated glomerular filtration rate ≥ 60 mL/min
  • No autoimmune disease requiring on-going immunosuppression
  • No evidence of current hepatitis B virus (HBV) infection
  • No evidence of current hepatitis C virus (HCV) infection (positive anti-HCV antibody and negative HCV polymerase chain reaction (PCR) results are acceptable)
  • No documented history of pre-ART CD4 nadir < 200 cells/μL (unknown pre-ART CD4 nadir is acceptable)
  • No history of opportunistic illness indicative of stage 3 HIV
  • No acute febrile illness within 35 days prior to Pre-Baseline/ Day -13

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03060447


Contacts
Contact: Gilead Clinical Study Information Center 1-833-445-3230 (GILEAD-0) GileadClinicalTrials@gilead.com

Locations
United States, California
Mills Clinical Research Recruiting
Los Angeles, California, United States, 90069
Zuckerberg San Francisco General Recruiting
San Francisco, California, United States, 94110
United States, Florida
Midway Immunology & Research Center Recruiting
Fort Pierce, Florida, United States, 34982
Orlando Immunology Center Recruiting
Orlando, Florida, United States, 32803
United States, Texas
Central Texas Clinical Research Recruiting
Austin, Texas, United States, 78705
United States, Washington
Peter Shalit, MD Recruiting
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Gilead Study Director Gilead Sciences

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT03060447     History of Changes
Other Study ID Numbers: GS-US-382-3961
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: June 2018

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