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

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.
 
ClinicalTrials.gov Identifier: NCT02275065
Recruitment Status : Completed
First Posted : October 27, 2014
Last Update Posted : February 10, 2015
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE October 23, 2014
First Posted Date  ICMJE October 27, 2014
Last Update Posted Date February 10, 2015
Study Start Date  ICMJE October 2014
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02275065 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2014)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Pharmacokinetics, and Antiviral Activity of GS-9883 in HIV-1 Infected Subjects
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE HIV-1 Infection
Intervention  ICMJE
  • Drug: GS-9883
    GS-9883 tablet(s) administered orally once daily
  • Drug: GS-9883 Placebo
    Placebo to match GS-9883 administered orally once daily
Study Arms  ICMJE
  • Experimental: Cohort 1
    GS-9883 1 × 25 mg tablet (or placebo to match) for 10 days.
    Interventions:
    • Drug: GS-9883
    • Drug: GS-9883 Placebo
  • Experimental: Cohort 2
    GS-9883 1 × 100 mg (or placebo to match) for 10 days.
    Interventions:
    • Drug: GS-9883
    • Drug: GS-9883 Placebo
  • Experimental: Cohort 3
    GS-9883 5 mg or 10 mg (1 × 5 or 2 × 5 mg tablet) (or placebo to match) for 10 days.
    Interventions:
    • Drug: GS-9883
    • Drug: GS-9883 Placebo
  • Experimental: Cohort 4
    GS-9883 50 mg or 75 mg (2 × 25 or 3 × 25 mg tablet) (or placebo to match) for 10 days.
    Interventions:
    • Drug: GS-9883
    • Drug: GS-9883 Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 6, 2015)
23
Original Estimated Enrollment  ICMJE
 (submitted: October 23, 2014)
32
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02275065
Other Study ID Numbers  ICMJE GS-US-141-1219
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gilead Sciences
Study Sponsor  ICMJE Gilead Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Hal Martin Gilead Sciences
PRS Account Gilead Sciences
Verification Date February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP