The Safety of Tenofovir Disoproxil Fumarate Taken With Other Anti-HIV Drugs to Treat HIV-Infected Patients

June 23, 2005 updated by: Gilead Sciences

A Phase 3, Open-Label, Multicenter Study of the Safety of Tenofovir Disoproxil Fumarate Administered in Combination With Other Antiretroviral Agents for the Treatment of HIV-1 Infected Patients

The purpose of this study is to evaluate the safety of tenofovir disoproxil fumarate (tenofovir DF) in combination with other anti-HIV drugs in patients who have participated in other tenofovir DF studies (GS-98-902 or GS-99-907), are able to tolerate the drug at different doses, and may benefit from having tenofovir DF treatment.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients take tenofovir DF in combination with other antiretrovirals.

Study Type

Interventional

Phase

  • Phase 3

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
      • Berkeley, California, United States, 94705
        • East Bay AIDS Ctr
      • Los Angeles, California, United States, 90048
        • Tower ID Med Associates
      • San Francisco, California, United States, 94115
        • Pacific Horizons Med Group
      • Torrance, California, United States, 90502
        • Harbor - UCLA Med Ctr
    • Colorado
      • Denver, Colorado, United States, 80262
        • Univ of Colorado / Health Science Ctr
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • Physicans Home Service
    • Florida
      • Miami, Florida, United States, 33133
        • Steinhart Medical Associates
      • Vero Beach, Florida, United States, 32960
        • Dr Gerald Pierone Jr
    • Illinois
      • Chicago, Illinois, United States, 60657
        • Northstar Med Clinic
    • Massachusetts
      • Brookline, Massachusetts, United States, 02146
        • CRI New England
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Univ of Minnesota
    • New York
      • Rochester, New York, United States, 14642
        • Univ of Rochester Med Ctr
    • Oregon
      • Portland, Oregon, United States, 97209
        • Research & Education Group
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Hershey Med Ctr
      • Pittsburgh, Pennsylvania, United States, 15221
        • Anderson Clinical Research
    • Rhode Island
      • Providence, Rhode Island, United States, 02908
        • Roger Williams Med Ctr
    • Texas
      • Dallas, Texas, United States, 75246
        • Southwest Infectious Diseases Associates
      • Houston, Texas, United States, 77009
        • Thomas Street Clinic
    • Washington
      • Tacoma, Washington, United States, 98405
        • Dr Philip C Craven

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

1 second and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Patients may be eligible for this study if they:

  • Have completed another study on tenofovir DF without toxicity.
  • Are willing to use intrauterine or effective barrier methods of birth control, both men and women, during the study and for 30 days following tenofovir DF treatment.

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Are taking drugs that may damage the kidney (nephrotoxic) including aminoglycoside antibiotics, amphotericin B, cidofovir, cisplatin, foscarnet, IV pentamidine, vancomycin, and oral or IV ganciclovir.
  • Are taking agents that affect kidney function, such as probenecid.
  • Are receiving systemic chemotherapy.
  • Are taking systemic corticosteroids.
  • Are taking experimental drugs except those that are approved by Gilead.
  • Are currently participating in the GS-99-908 or GS-00-912 (expanded access) studies.
  • Are pregnant or breast-feeding.

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

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 Registration Dates

First Submitted

December 19, 2000

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

July 1, 2001

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 283F
  • GS-99-910

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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