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

January 13, 2014 updated by: Gilead Sciences

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Stanford Positive Care Program
    • Illinois
      • Chicago, Illinois, United States, 60610
        • Protocare Trials Chicago Center for Clinical Trials
    • New York
      • New York, New York, United States, 10021
        • Rockefeller University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • GS-7340

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to Week 2

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2002

Primary Completion (Actual)

February 1, 2003

Study Completion (Actual)

February 1, 2003

Study Registration Dates

First Submitted

May 13, 2002

First Submitted That Met QC Criteria

May 13, 2002

First Posted (Estimate)

May 14, 2002

Study Record Updates

Last Update Posted (Estimate)

January 15, 2014

Last Update Submitted That Met QC Criteria

January 13, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-120-1101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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