Tenofovir Disoproxil Fumarate (TDF) in HIV-1 Patients Who Have Never Taken Anti-HIV Drugs

June 23, 2005 updated by: Gilead Sciences

An Open-Label Study to Assess the Anti-HIV-1 Activity of Tenofovir Disoproxil Fumarate (TDF) in Antiretroviral-Naive Patients Who Are Chronically Infected With HIV-1

The purpose of this study is to look at the effectiveness of tenofovir disoproxil fumarate (TDF) in HIV-infected patients who have never taken anti-HIV drugs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients receive TDF.

Study Type

Interventional

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
    • New York
      • New York, New York, United States, 10021
        • Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ

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

Patients may be eligible for this study if they:

  • Are HIV-positive.
  • Have a plasma viral load (level of HIV in the blood) of 10,000 copies/ml or more.
  • Have a CD4 count of 50 cells/mm3 or more.
  • Have a negative pregnancy test.
  • Agree to use 2 forms of barrier birth control while on the study and for 30 days afterwards.
  • Are 18 to 65 years old.

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Have had treatment with any of the following types of anti-HIV drugs: nucleoside reverse transcriptase inhibitors, nucleotide reverse transcriptase inhibitors (e.g., adefovir dipivoxil or TDF), protease inhibitors, or nonnucleoside reverse transcriptase inhibitors.
  • Have received a vaccination within 30 days before study entry.
  • Have had a new AIDS-defining illness diagnosed within 30 days before study entry.
  • Are taking any of the following: drugs that may cause kidney problems, including aminoglycoside antibiotics, cidofovir, cisplatin, foscarnet, intravenous (IV) amphotericin B, IV vancomycin, oral and IV ganciclovir, and valganciclovir; probenecid; chemotherapy; steroid drugs; interleukin-2; or investigational drugs.
  • Are pregnant or breast-feeding.
  • Have difficulty taking, absorbing, or tolerating drugs by mouth, as may be shown by long-term nausea or vomiting.
  • Abuse alcohol or drugs.
  • Have cancer other than Kaposi's sarcoma or basal cell carcinoma.
  • Have other infections that need injectable antibiotics within 15 days before study entry.
  • Have had kidney or bone disease.
  • Have any medical conditions or past treatments that the study investigator believes would make the patient unsuitable for the study.

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
  • Masking: None (Open Label)

Collaborators and Investigators

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

Sponsor

Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Louie M, Hogan C, Hurley A, Captan B, Flaherty J, Lamy P, Balagtas A, Coakley D, Chung C, Ho D. Determining The Relative Efficacy of Tenofovir DF Using Frequent Measurments of HIV-1 RNA During A Short Course of Monotherapy In Antiretroviral Drug Naive Individuals. D, Markowitz M. 9th Conference on Retroviruses and Opportunistic Infections 2002 Feb 24-28

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

May 1, 2001

Study Registration Dates

First Submitted

May 17, 2001

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, 2002

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 283H
  • GS-00-917

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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