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

Completed · Phase 1

Conditions studied: HIV Infections

In brief

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

Key facts

Study ID

NCT00002326

Run by

Gilead Sciences

People needed

20

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Natl Cancer Institute — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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