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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
This study has been completed.
First Received: November 2, 1999   Last Updated: June 23, 2005   History of Changes
Sponsor: Gilead Sciences
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002161
  Purpose

To evaluate the anti-HIV activity, safety, and tolerance of adefovir dipivoxil ( bis-POM PMEA ) in combination with standard antiretroviral therapy for 48 weeks.


Condition Intervention
HIV Infections
Drug: Adefovir dipivoxil

Study Type: Interventional
Study Design: Treatment, Double-Blind, Safety Study
Official Title: 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

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 400
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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002161

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

No publications provided

Study ID Numbers: 232C, GS-96-408
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00002161     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Antiviral Agents
Adenine

Additional relevant MeSH terms:
Anti-Infective Agents
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Immunologic Deficiency Syndromes
Reverse Transcriptase Inhibitors
Virus Diseases
Anti-Retroviral Agents
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Adefovir dipivoxil
Adefovir
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on November 25, 2009