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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

Study Description
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Brief Summary:
This study evaluated two doses of tenofovir alafenamide versus tenofovir disoproxil fumarate (tenofovir DF).

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Tenofovir DF Drug: Tenofovir alafenamide Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : March 2002
Actual Primary Completion Date : February 2003
Actual Study Completion Date : February 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change from baseline in HIV-1 RNA (log10 copies/mL) [ Time Frame: Baseline to Week 2 ]
  2. Change from baseline in CD4 cell count (cells/mm3) [ Time Frame: Baseline to Week 2 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00036634


Locations
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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
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00036634    
Other Study ID Numbers: GS-120-1101
First Posted: May 14, 2002    Key Record Dates
Last Update Posted: January 15, 2014
Last Verified: January 2014
Keywords provided by Gilead Sciences:
treatment naive
Additional relevant MeSH terms:
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HIV Infections
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Genital Diseases
Urogenital Diseases
 Immunologic Deficiency Syndromes
Immune System Diseases
Tenofovir
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents