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

Completed · Not applicable

Conditions studied: HIV Infections

In brief

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

Key facts

Study ID

NCT00002161

Run by

Gilead Sciences

People needed

400

Last updated by the study team

2005-06-24

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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