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A Dose Escalation Study of Tenofovir Alafenamide in Treatment-Naive Patients

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: NCT00036634
Recruitment Status : Completed
First Posted : May 14, 2002
Last Update Posted : January 15, 2014
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE May 13, 2002
First Posted Date  ICMJE May 14, 2002
Last Update Posted Date January 15, 2014
Study Start Date  ICMJE March 2002
Actual Primary Completion Date February 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 13, 2014)
Time-weighted average change from baseline through Week 2 (DAVG2) for HIV-1 RNA (log10 copies/mL) [ Time Frame: Baseline to Week 2 ]
DAVG2 was defined as the time-weighted average between baseline value through the last available value up to week 2 minus the baseline value.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2014)
  • Change from baseline in HIV-1 RNA (log10 copies/mL) [ Time Frame: Baseline to Week 2 ]
  • Change from baseline in CD4 cell count (cells/mm3) [ Time Frame: Baseline to Week 2 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Dose Escalation Study of Tenofovir Alafenamide in Treatment-Naive Patients
Official Title  ICMJE A Phase 1/2, Randomized, Double-Blind, Active Controlled, Dose Escalation Study of the Safety, Tolerance, Pharmacokinetic,, and Antiviral Activity of GS-7340-02 in Antiretroviral-Naive Patients Who Are Chronically Infected With HIV-1
Brief Summary This study evaluated two doses of tenofovir alafenamide versus tenofovir disoproxil fumarate (tenofovir DF).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE HIV Infections
Intervention  ICMJE
  • Drug: Tenofovir DF
    Tenofovir DF tablet administered orally once daily
    Other Name: Viread®
  • Drug: Tenofovir alafenamide
    Tenofovir alafenamide tablet(s) administered orally once daily
    Other Name: GS-7340
Study Arms  ICMJE
  • Active Comparator: Tenofovir DF
    Participants received tenofovir DF 300 mg for 14 days
    Intervention: Drug: Tenofovir DF
  • Experimental: Tenofovir alafenamide 50 mg
    Participants received tenofovir alafenamide 50 mg for 14 days
    Intervention: Drug: Tenofovir alafenamide
  • Experimental: Tenofovir alafenamide 150 mg
    Participants received tenofovir alafenamide 150 mg for 14 days
    Intervention: Drug: Tenofovir alafenamide
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: June 23, 2005)
30
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2003
Actual Primary Completion Date February 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  • HIV-1 RNA levels greater than or equal to 30,000 copies/mL
  • CD4 count greater than or equal to 200 cells/mm3
  • Serum creatinine <1.5 mg/dl
  • Hepatic transaminases less than or equal to 2.5 times the upper limit of normal
  • Total bilirubin less than or equal to 1.5 mg/dL
  • Adequate hematologic function
  • Serum amylase less than or equal to 1.5 times the upper limit of normal
  • Serum phosphate greater than or equal to 2.2 mg/dL
  • Not pregnant

Exclusion Criteria

  • Prior treatment with antiretroviral therapy
  • Immunization within 30 days of study entry
  • A new AIDS defining condition within 30 days of study entry
  • Receiving nephrotoxic agents, probenecid, chemotherapeutic agents, corticosteroids, interleukin-2
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 NCT00036634
Other Study ID Numbers  ICMJE GS-120-1101
Has Data Monitoring Committee Not Provided
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 Not Provided
PRS Account Gilead Sciences
Verification Date January 2014

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