The Safety and Effectiveness of Zidovudine Plus Adefovir in HIV-Infected Patients
HIV Infections

About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents, Zidovudine, Adenine
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Allowed: Prophylactic therapy with aerosolized pentamidine, oral trimethoprim/sulfamethoxazole (Bactrim, Septra) or dapsone, and fluconazole or ketoconazole IF on a stable regimen for at least 4 weeks prior to study entry. Patients must have: HIV seropositivity. Mean CD4 count <= 500 cells/mm3. Been receiving AZT at 500 mg daily for at least 4 weeks prior to study entry. Life expectancy of at least 3 months. NOTE: Kaposi's sarcoma is permitted provided patient has not received any systemic therapy for KS within the past 4 weeks. Patients with a history of another malignancy must be disease free for 6 months or more prior to study entry. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Inadequate venous access. Active, serious infections (other than HIV infection) requiring parenteral antibiotic therapy. Clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or clinically significant arrhythmia. Active malignancy other than Kaposi's sarcoma. Mental incapacity or illness that may affect compliance. Concurrent Medication: Excluded: ddI or ddC. Interferon alpha. Ganciclovir. Foscarnet. Diuretics. Investigational agents including d4T. Chemotherapeutic agents. Amphotericin B. Aminoglycoside antibiotics. Other nephrotoxic agents. Immunomodulatory agents. Parenteral therapy for an active, serious infection (other than HIV infection). Prior Medication: Excluded within 2 weeks prior to study entry: ddI or ddC. Interferon alpha. Ganciclovir. Foscarnet. Diuretics. Investigational agents including d4T. Chemotherapeutic agents. Amphotericin B. Aminoglycoside antibiotics. Other nephrotoxic agents. Immunomodulatory agents. Excluded within 4 weeks prior to study entry: Systemic therapy for Kaposi's sarcoma. Required: AZT at a stable dose for at least 4 weeks prior to study entry. Current use of illicit drugs (e.g., heroin or cocaine). Ingestion of substantial alcohol.
Sites / Locations
- Natl Cancer Institute