A Compassionate Use Study of Tenofovir Disoproxil Fumarate as Treatment for HIV Infection

June 23, 2005 updated by: Gilead Sciences

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

This study allows patients who need a new anti-HIV treatment to take tenofovir disoproxil fumarate (tenofovir DF), an experimental drug. This study also looks at any side effects the drug causes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

HIV-1-infected patients who are currently receiving stable antiretroviral therapy add tenofovir DF to their regimen. Study participation lasts for approximately 48 weeks. Interested patients should contact their physicians.

Study Type

Interventional

Enrollment

300

Phase

  • Not Applicable

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
      • Foster City, California, United States, 94404
        • Tenofovir Coordinating Center

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

You may be eligible for this study if you:

  • Are HIV-positive.
  • Have a viral load greater than or equal to 10,000 copies/ml.
  • Have a CD4 count less than or equal to 50 cells/mm3, or have a CD4 count greater than 50 and no more than 200 cells/mm3 with an opportunistic (AIDS-related) infection within 90 days of study entry. (Patients with a CD4 count above 200 cells/mm3 may be considered depending on drug supply.)
  • Are at least 18 years old.
  • Agree to use barrier methods of birth control (such as condoms) while on the study and for 30 days afterward.
  • Have a life expectancy of at least one year.

Exclusion Criteria

You will not be eligible for this study if you:

  • Have a history of a serious kidney or bone disease.
  • Have severe nausea, vomiting, or trouble taking medications by mouth.
  • Are pregnant or breast-feeding.
  • Abuse alcohol or other substances that your doctor thinks would interfere with taking this medicine.
  • Are taking any medicines that interfere with kidney functions.

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 Major Dates

Study Start

December 1, 1999

Study Registration Dates

First Submitted

January 24, 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

May 1, 2000

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 283C
  • GS-99-908

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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