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

Gilead Sciences

Status: Completed

Conditions: HIV Infections

Treatments: Drug: Adefovir dipivoxil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002161

GS-96-408

232C

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.