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
  Purpose

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

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00036634

Locations
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
ClinicalTrials.gov 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:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Tenofovir
Tenofovir disoproxil
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on April 15, 2014