A Phase I/II Study of the Safety, Tolerance, and Pharmacokinetics of 9-(2-Phosphonylmethoxyethyl)Adenine ( PMEA; Adefovir ) in Patients With Advanced HIV Disease.

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

To study the safety, tolerance, pharmacokinetics, and anti-HIV effects of PMEA ( adefovir ) when administered daily by intravenous (IV) and/or subcutaneous (SC) injection in patients with advanced HIV disease.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Adefovir; Adefovir dipivoxil

Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

• Other antiretroviral therapy IF on a stable dose for at least 4 weeks prior to study entry.

• Prophylactic therapy with aerosolized pentamidine, oral trimethoprim/sulfamethoxazole (Bactrim, Septra) or dapsone, and fluconazole or ketoconazole IF on a stable prophylactic regimen for at least 4 weeks prior to study entry.

Patients must have:

• HIV seropositivity.

• Elevated p24 antigen (> 40 pg/ml).

• Mean CD4 count <= 100 cells/mm3.

• Life expectancy of at least 3 months.

Prior Medication:

Allowed:

• Other prior antiretroviral therapy.

• Prophylactic therapy with aerosolized pentamidine, oral trimethoprim/sulfamethoxazole (Bactrim, Septra) or dapsone, and fluconazole or ketoconazole.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Inadequate venous access.

• Active serious infection (other than HIV infection) requiring parenteral antibiotic therapy.

• Clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia.

• Psychiatric disturbance or illness that may affect compliance.

• Malignancy other than Kaposi's sarcoma.

Concurrent Medication:

Excluded:

• Investigational agents other than stavudine (d4T).

• Interferon-alpha.

• Ganciclovir.

• Foscarnet.

• Diuretics.

• Amphotericin B.

• Aminoglycoside antibiotics.

• Other nephrotoxic agents.

• Acyclovir at doses >= 2 g/day.

Prior Medication:

Excluded within 2 weeks prior to study entry:

• Investigational agents other than stavudine (d4T).

• Interferon-alpha.

• Ganciclovir.

• Foscarnet.

• Diuretics.

• Amphotericin B.

• Aminoglycoside antibiotics.

• Other nephrotoxic agents.

Excluded within 4 weeks prior to study entry:

• Systemic therapy for Kaposi's sarcoma. Substance abuse.