Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

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

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

Condition Intervention Phase
HIV Infections
Drug: Tenofovir DF
Drug: Tenofovir alafenamide
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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 ]

Enrollment: 30
Study Start Date: March 2002
Study Completion Date: February 2003
Primary Completion Date: February 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tenofovir DF
Participants received tenofovir DF 300 mg for 14 days
Drug: Tenofovir DF
Tenofovir DF tablet administered orally once daily
Other Name: Viread®
Experimental: Tenofovir alafenamide 50 mg
Participants received tenofovir alafenamide 50 mg for 14 days
Drug: Tenofovir alafenamide
Tenofovir alafenamide tablet(s) administered orally once daily
Other Name: GS-7340
Experimental: Tenofovir alafenamide 150 mg
Participants received tenofovir alafenamide 150 mg for 14 days
Drug: Tenofovir alafenamide
Tenofovir alafenamide tablet(s) administered orally once daily
Other Name: GS-7340


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00036634

United States, California
Stanford Positive Care Program
Palo Alto, California, United States, 94304
United States, Illinois
Protocare Trials Chicago Center for Clinical Trials
Chicago, Illinois, United States, 60610
United States, New York
Rockefeller University Hospital
New York, New York, United States, 10021
Sponsors and Collaborators
Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences Identifier: NCT00036634     History of Changes
Other Study ID Numbers: GS-120-1101
Study First Received: May 13, 2002
Last Updated: January 13, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
treatment naive

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Tenofovir disoproxil
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses processed this record on February 25, 2015