A Phase I/II Study of the Safety, Tolerance, and Pharmacokinetics of Combination Zidovudine (AZT) and 9-(2-Phosphonylmethoxyethyl)Adenine (PMEA; Adefovir) Treatment in HIV-Infected Patients

Gilead Sciences1 个研究点分布在 1 个国家目标入组 20 人开始时间: 2001年8月31日最近更新: 2005年6月24日

适应症

试验速览

To study the safety, tolerance, pharmacokinetics, and anti-HIV effects of combination zidovudine (AZT) and PMEA (adefovir) therapy.

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

•Concurrent Medication:
•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/mm
•Been receiving AZT at 500 mg daily for at least 4 weeks prior to study entry.
•Life expectancy of at least 3 months.
•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.

•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:
•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.
•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.

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