A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Adefovir Dipivoxil When Added to Standard Antiretroviral Therapy for the Treatment of HIV-Infected Patients With CD4 Cell Counts >= 200/mm3

June 23, 2005 updated by: Gilead Sciences
To evaluate the anti-HIV activity, safety, and tolerance of adefovir dipivoxil ( bis-POM PMEA ) in combination with standard antiretroviral therapy for 48 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients are randomized to receive either adefovir dipivoxil or placebo daily for 24 weeks, after which all patients will receive open-label drug for an additional 24 weeks. Study drug is administered in combination with a current antiretroviral regimen for the entire 48 weeks. Patients are followed every 4 weeks during the first 24 weeks of study, then every 8 weeks during the last 24 weeks.

Study Type

Interventional

Enrollment

400

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
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Univ of Alabama at Birmingham
    • California
      • Berkeley, California, United States, 94705
        • East Bay AIDS Ctr
      • Los Angeles, California, United States, 90509
        • Kraus Med Partners
      • San Francisco, California, United States, 94115
        • San Francisco Gen Hosp
      • San Jose, California, United States, 951282699
        • Santa Clara Valley Med Ctr
      • San Mateo, California, United States, 94403
        • San Mateo County Med Ctr / San Mateo County AIDS Prog
      • Sherman Oaks, California, United States, 91403
        • Pacific Oaks Research
      • Torrance, California, United States, 90502
        • Harbor UCLA Med Ctr
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown Univ Med Ctr
      • Washington, District of Columbia, United States, 20422
        • Institute for Clinical Research
    • Florida
      • St. Petersburg, Florida, United States, 33705
        • Univ of South Florida
    • Georgia
      • Atlanta, Georgia, United States, 303081962
        • AIDS Research Consortium of Atlanta
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Univ Med Ctr
      • Chicago, Illinois, United States, 60610
        • Chicago Ctr for Clinical Research
    • Louisiana
      • New Orleans, Louisiana, United States, 70122
        • Tulane Univ / Tulane / LSU Clinical Trials Unit
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Harvard Univ / Massachusetts Gen Hosp
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Wayne State Univ / Univ Health Ctr
    • New York
      • Albany, New York, United States, 12208
        • Albany Med College / Clinical Pharmacy Studies
      • New York, New York, United States, 10011
        • Saint Vincent's Med Ctr
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Carolinas Med Ctr
    • Oregon
      • Portland, Oregon, United States, 97210
        • The Research and Education Group
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt Univ Med Ctr
    • Texas
      • Dallas, Texas, United States, 75216
        • Dallas VA Med Ctr
      • Galveston, Texas, United States, 77555
        • Univ of Texas
      • Houston, Texas, United States, 77004
        • Houston Clinical Research Network
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Univ of Utah School of Medicine
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Univ of Wisconsin

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

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Patients must have:

  • HIV infection with HIV RNA titer >= 2500 copies/ml (2.5 KEq/ml) plasma.
  • CD4 count >= 200 cells/mm3.
  • No new AIDS-defining event within the past 2 months.
  • Life expectancy at least 1 year.
  • Consent of parent or guardian if less than 18 years old.
  • Tolerated antiretroviral therapy for the past 2 months.

NOTE:

  • Kaposi's sarcoma is permitted provided patient has not received systemic therapy within the past month.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Active, serious infections other than HIV that require parenteral antibiotic or antiviral therapy.
  • Gastrointestinal malabsorption syndrome or chronic nausea or vomiting that would preclude oral medication.
  • Malignancy other than Kaposi's sarcoma or basal cell carcinoma.

Concurrent Medication:

Excluded:

  • Immunomodulating agents such as systemic corticosteroids, IL-2, or interferons.
  • Isoniazid.
  • Rifampin.
  • Investigational agents (unless approved by sponsor).
  • Systemic chemotherapeutic agents.

Prior Medication:

Excluded:

  • Parenteral antibiotic or antiviral therapy for another active, serious infection within the past 2 weeks.
  • Immunomodulating agents such as systemic corticosteroids, IL-2, or interferons within the past month.
  • Systemic therapy for KS within the past month.

Required:

  • Antiretroviral regimen other than study drug.

Required:

  • Antiretroviral therapy for at least the past 2 months. Current alcohol or substance abuse that would interfere with compliance.

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

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

May 1, 1997

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 232C
  • GS-96-408

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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