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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00036634
First received: May 13, 2002
Last updated: January 13, 2014
Last verified: January 2014

May 13, 2002
January 13, 2014
March 2002
February 2003   (final data collection date for primary outcome measure)
Time-weighted average change from baseline through Week 2 (DAVG2) for HIV-1 RNA (log10 copies/mL) [ Time Frame: Baseline to Week 2 ] [ Designated as safety issue: No ]
DAVG2 was defined as the time-weighted average between baseline value through the last available value up to week 2 minus the baseline value.
Not Provided
Complete list of historical versions of study NCT00036634 on ClinicalTrials.gov Archive Site
  • Change from baseline in HIV-1 RNA (log10 copies/mL) [ Time Frame: Baseline to Week 2 ] [ Designated as safety issue: No ]
  • Change from baseline in CD4 cell count (cells/mm3) [ Time Frame: Baseline to Week 2 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
A Dose Escalation Study of Tenofovir Alafenamide in Treatment-Naive Patients
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

This study evaluated two doses of tenofovir alafenamide versus tenofovir disoproxil fumarate (tenofovir DF).

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
HIV Infections
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
February 2003
February 2003   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00036634
GS-120-1101
Not Provided
Gilead Sciences
Gilead Sciences
Not Provided
Not Provided
Gilead Sciences
January 2014

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