A Study of BMY-27857 in Patients With AIDS or AIDS Related Complex

Exclusion Criteria

• •Co-existing Condition:
• •Patients with the following are excluded:
• •Active, AIDS-defining opportunistic infection.
• •Intractable diarrhea.
• •History or propensity for seizure disorders requiring anticonvulsants for control.
• •Any other clinical condition which in the opinion of the investigator would make the patient unsuitable or unable to comply with the dosing requirements.
• •Concurrent Medication:
• •Excluded:
• •Systemic therapy with this or any other antiretroviral drug (including AL-721, ddI, ddC, interferon, immunomodulating drugs) or investigational drug.
• •Ribavirin.
• •Cytotoxic anticancer therapy.
• •Therapy with any agent known as a potent inducer or inhibitor of drug-metabolizing enzymes, such as rifampin or barbiturates.
• •Systemic maintenance or chemoprophylaxis for opportunistic infections.
• •Trimethoprim / sulfamethoxazole for Pneumocystis carinii infections.
• •Acute therapy with ketoconazole for thrush.
• •Neurotoxic agents listed in the protocol.
• •Patients with the following are excluded:
• •Previous intolerance to zidovudine (AZT) as demonstrated by transfusion dependent anemia (transfusion required every 3 weeks or less and AZT-related depression of neutrophils to \< 500 cells/mm3).
• •Life expectancy \< 6 months.
• •Prior Medication:
• •Excluded:
• •Any other prior therapy which in the opinion of the investigator would make the patient unsuitable or unable to comply with the dosing requirements.
• •Excluded within 2 weeks of study entry:
• •Therapy with any agent known as a potent inducer or inhibitor of drug-metabolizing enzymes, such as rifampin or barbiturates.
• •Excluded within 1 month of study entry:
• •Systemic therapy with this or any other antiretroviral drug (including AL-721, interferon, immunomodulating drugs, ddI, ddC) or any investigational drug.
• •Excluded within 3 months of study entry:
• •Ribavirin.
• •Cytotoxic anticancer therapy.
• •Prior Treatment:
• •Excluded:
• •Any prior therapy which in the opinion of the investigator would make the patient unsuitable or unable to comply with the dosing requirements.
• •Preference:
• •Tolerating zidovudine (AZT) at time of study entry.
• •Active alcohol or drug abuse sufficient, in the investigator's opinion, to prevent adequate compliance with study therapy.