Safety and Effectiveness of Adding PMPA Prodrug to an Anti-HIV Drug Combination to Treat HIV-Infected Patients

June 23, 2005 updated by: Gilead Sciences

A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Antiviral Activity of the Addition of PMPA Prodrug to Combination Antiretroviral Regimens in Treatment-Experienced HIV-Infected Patients

The purpose of this study is to see if it is safe and effective to add PMPA Prodrug (a new anti-HIV drug) to an anti-HIV drug combination taken by patients who have taken anti-HIV drugs in the past. Genetic response will be studied.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Prior to study entry patients are stratified according to HIV-1 RNA level, CD4 cell count, and number of antiretroviral drugs. PMPA Prodrug or placebo is added to current antiretroviral regimens, and is administered in one of three dosing regimens. Patients randomized to receive placebo are eligible to receive open-label PMPA Prodrug for the remainder of the 48-week study period after at least 24 weeks post randomization.

Study Type

Interventional

Enrollment

175

Phase

  • Phase 2

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
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Univ of Alabama at Birmingham / 1917 Rsch Cln
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • McDowell Clinic
    • California
      • Berkeley, California, United States, 94705
        • East Bay AIDS Ctr
      • Los Angeles, California, United States, 90048
        • Tower Infectious Disease Med Ctr
      • San Diego, California, United States, 92103
        • UCSD Treatment Ctr
      • San Francisco, California, United States, 94121
        • San Francisco Veterans Adm Med Cntr
      • Torrance, California, United States, 90502
        • Harbor UCLA Med Ctr
    • Colorado
      • Denver, Colorado, United States, 80262
        • Univ of Colorado Health Sciences Ctr
    • Florida
      • Tampa, Florida, United States, 33605
        • Hillsborough County Health Dept Special Care Ctr
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • AIDS Research Consortium of Atlanta Inc
      • Atlanta, Georgia, United States, 30308
        • Grady Mem Hosp
      • Atlanta, Georgia, United States, 30324
        • Private Practice / Thacker and Thompson
    • Illinois
      • Chicago, Illinois, United States, 60657
        • Northstar Med Clinic
    • Massachusetts
      • Brookline, Massachusetts, United States, 02445
        • CRI New England
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Univ of Minnesota
    • New York
      • New York, New York, United States, 10003
        • Beth Israel Med Ctr
      • New York, New York, United States, 10011
        • Cornell Clinical Trials Unit - Chelsea Clinic
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Univ Hosps of Cleveland
    • Oregon
      • Portland, Oregon, United States, 97210
        • The Research and Education Group
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Hershey Med Ctr
      • Pittsburgh, Pennsylvania, United States, 15213
        • Anderson Clinical Research
    • Rhode Island
      • Providence, Rhode Island, United States, 02908
        • Roger Williams Med Ctr
    • Texas
      • Dallas, Texas, United States, 75235
        • Amelia Ct Clinic
      • Houston, Texas, United States, 77009
        • Thomas Street Clinic

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

You may be eligible for this study if you:

  • Are HIV-positive.
  • Have an HIV count of 400 - 50,000 copies/ml.
  • Are expected to live for at least 1 year.
  • Have been taking the same anti-HIV drug combination (made up of no more than 3 anti-HIV drugs) for at least 8 weeks prior to study entry.
  • Are at least 18 years old.
  • Agree to use effective methods of birth control during the study.

Exclusion Criteria

You will not be eligible for this study if you:

  • Have taken medications for certain infections within 15 days prior to study entry.
  • Have a history of cancer, except Kaposi's sarcoma (KS) or skin cancer.
  • Develop a new AIDS-related condition within 30 days of study entry.
  • Have certain serious medical conditions, including severe nausea, vomiting, or other stomach problems that make you unable to take medications by mouth.
  • Have received a vaccine within 30 days prior to study entry.
  • Have taken certain medications, including those that may affect your kidneys.
  • Abuse alcohol or drugs.
  • Are pregnant.

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: Double

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

  • Miller MD, Margot NA, Schooley R, McGowan I. Baseline and week 48 final phenotypic analysis of HIV-1 from patients adding tenofovir disoproxil fumarate (TDF) therapy to background ART. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 441)
  • Schooley R, Myers R, Ruane R, Beall G, Lampiris H, McGowan I. A double-blind, placebo-controlled study of tenofovir disoproxil fumarate (TDF) for the treatment of HIV infection. 39th Intersci Conf Antimicrob Agents Chemother. 1999 Sep (abstract no I302I)

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

November 2, 1999

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

November 1, 1999

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 283B
  • GS-98-902

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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