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

Launched by GILEAD SCIENCES · Aug 30, 2001

Keywords

ClinConnect Summary

Patients receive AZT daily and intravenous PMEA three times weekly for 4 weeks. An MTD will be defined for this regimen.

Gender

ALL

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.