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Safety, Pharmacokinetics, and Antiviral Activity of GS-9883 in HIV-1 Infected Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02275065
First Posted: October 27, 2014
Last Update Posted: February 10, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gilead Sciences
  Purpose
This study will investigate the short-term antiviral potency, safety, plasma pharmacokinetics (PK), and the PK/pharmacodynamic (PD) relationship (the dose-response relationship) of GS-9883 at multiple doses in antiretroviral (ART) treatment-naive adult subjects and subjects who are ART-experienced but are currently off of ART therapy. Up to 32 participants will be enrolled in the study.

Condition Intervention Phase
HIV-1 Infection Drug: GS-9883 Drug: GS-9883 Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1b Randomized, Double-Blinded, Sequential Cohort Placebo-Controlled Study of the Safety, Pharmacokinetics, and Antiviral Activity of GS-9883 in HIV-1 Infected Subjects

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • DAVG11 in plasma HIV-1 RNA (log10 copies/mL) [ Time Frame: Up to 11 days ]
    DAVG11: time-weighted average between the first postbaseline value and the last available value up to Day 11 minus the baseline value.


Secondary Outcome Measures:
  • Incidence of adverse events and graded laboratory abnormalities [ Time Frame: Up to 11 days ]
    Overall safety profile will be characterized by number of participants experiencing adverse events or laboratory abnormalities.

  • Maximum reduction from baseline through Day 11 in plasma HIV-1 RNA (log10 copies/mL) [ Time Frame: Up to 11 Days ]
    The maximum reduction will be calculated as the lowest up to Day 11 postbaseline value minus the baseline value.

  • PK parameters of GS-9883 following single- and multiple-dose administration, and the correlation between AUCtau of GS-9883 and DAVG11 in plasma HIV-1 RNA [ Time Frame: Predose and postdose on Days 1 and 10 ]

    DAVG11: time-weighted average between the first postbaseline value and the last available value up to Day 11 minus the baseline value.

    AUCtau: concentration of drug over time

    • PK measurements will include: AUCinf, AUC0-last, and Cmax for single-dose administration; and AUCtau, Cmax, and Ctau for multiple-dose administration.
    • PK/PD measurements will include Pearson correlation between AUCtau of GS-9883 and DAVG11 in plasma HIV-1 RNA

  • Initial viral decay slope in plasma HIV-1 RNA (copies/mL) [ Time Frame: Up to 11 days ]
    The ratio of the mean slopes between treatment pairs of interest will be calculated.


Enrollment: 23
Study Start Date: October 2014
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
GS-9883 1 × 25 mg tablet (or placebo to match) for 10 days.
Drug: GS-9883
GS-9883 tablet(s) administered orally once daily
Drug: GS-9883 Placebo
Placebo to match GS-9883 administered orally once daily
Experimental: Cohort 2
GS-9883 1 × 100 mg (or placebo to match) for 10 days.
Drug: GS-9883
GS-9883 tablet(s) administered orally once daily
Drug: GS-9883 Placebo
Placebo to match GS-9883 administered orally once daily
Experimental: Cohort 3
GS-9883 5 mg or 10 mg (1 × 5 or 2 × 5 mg tablet) (or placebo to match) for 10 days.
Drug: GS-9883
GS-9883 tablet(s) administered orally once daily
Drug: GS-9883 Placebo
Placebo to match GS-9883 administered orally once daily
Experimental: Cohort 4
GS-9883 50 mg or 75 mg (2 × 25 or 3 × 25 mg tablet) (or placebo to match) for 10 days.
Drug: GS-9883
GS-9883 tablet(s) administered orally once daily
Drug: GS-9883 Placebo
Placebo to match GS-9883 administered orally once daily

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • No current or prior anti-HIV treatment, including antiretroviral medications received for prevention (preexposure prophylaxis [PrEP]), or postexposure prophylaxis (PEP) within 12 weeks of screening
  • Must be between 18 and 65 years of age, inclusive on the date of the screening visit
  • Plasma HIV-1 RNA ≥ 10,000 copies/mL but ≤ 400,000 copies/mL at screening
  • CD4+ cell count > 200 cells/mm^3

Exclusion Criteria:

  • Anticipated to start HIV-1 therapy during the study period
  • Active participation in another study of investigational or approved antiretroviral agents
  • A new AIDS-defining condition diagnosed within the 30 days prior to screening
  • Subjects with positive hepatitis C antibody at screening
  • Chronic hepatitis B virus (HBV) infection
  • Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 42 days prior to Day 1 (baseline)
  Contacts and Locations
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): NCT02275065


Locations
United States, California
Berkeley, California, United States
Davis, California, United States
Long Beach, California, United States
Los Angeles, California, United States
San Francisco, California, United States
United States, District of Columbia
Washington, District of Columbia, United States
United States, Florida
Fort Lauderdale, Florida, United States
Orlando, Florida, United States
Vero Beach, Florida, United States
West Palm Beach, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
United States, Michigan
Berkley, Michigan, United States
United States, New Jersey
Newark, New Jersey, United States
United States, New Mexico
Santa Fe, New Mexico, United States
United States, Texas
Dallas, Texas, United States
United States, Washington
Seattle, Washington, United States
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Hal Martin Gilead Sciences
  More Information

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02275065     History of Changes
Other Study ID Numbers: GS-US-141-1219
First Submitted: October 23, 2014
First Posted: October 27, 2014
Last Update Posted: February 10, 2015
Last Verified: February 2015

Keywords provided by Gilead Sciences:
HIV-1 Infected
Adults
Treatment Naive

Additional relevant MeSH terms:
Antiviral Agents
Anti-Infective Agents


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