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
NCT ID: NCT00002161
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
400 participants
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
DOUBLE
Interventions
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Adefovir dipivoxil
Eligibility Criteria
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Inclusion Criteria
* 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
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.
13 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Locations
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Univ of Alabama at Birmingham
Birmingham, Alabama, United States
East Bay AIDS Ctr
Berkeley, California, United States
Kraus Med Partners
Los Angeles, California, United States
San Francisco Gen Hosp
San Francisco, California, United States
Santa Clara Valley Med Ctr
San Jose, California, United States
San Mateo County Med Ctr / San Mateo County AIDS Prog
San Mateo, California, United States
Pacific Oaks Research
Sherman Oaks, California, United States
Harbor UCLA Med Ctr
Torrance, California, United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, United States
Institute for Clinical Research
Washington D.C., District of Columbia, United States
Univ of South Florida
St. Petersburg, Florida, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States
Chicago Ctr for Clinical Research
Chicago, Illinois, United States
Northwestern Univ Med Ctr
Chicago, Illinois, United States
Tulane Univ / Tulane / LSU Clinical Trials Unit
New Orleans, Louisiana, United States
Harvard Univ / Massachusetts Gen Hosp
Boston, Massachusetts, United States
Wayne State Univ / Univ Health Ctr
Detroit, Michigan, United States
Albany Med College / Clinical Pharmacy Studies
Albany, New York, United States
Saint Vincent's Med Ctr
New York, New York, United States
Carolinas Med Ctr
Charlotte, North Carolina, United States
The Research and Education Group
Portland, Oregon, United States
Vanderbilt Univ Med Ctr
Nashville, Tennessee, United States
Dallas VA Med Ctr
Dallas, Texas, United States
Univ of Texas
Galveston, Texas, United States
Houston Clinical Research Network
Houston, Texas, United States
Univ of Utah School of Medicine
Salt Lake City, Utah, United States
Univ of Wisconsin
Madison, Wisconsin, United States
Countries
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Other Identifiers
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GS-96-408
Identifier Type: -
Identifier Source: secondary_id
232C
Identifier Type: -
Identifier Source: org_study_id