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