Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria

Patients must have:

HIV infection.
Asymptomatic or mildly symptomatic.
CD4 count 100 - 300 cells/mm3.

Prior Medication:

Allowed:

Prior antiretroviral agents for up to 6 months per agent.

Exclusion Criteria

Co-existing Condition:

Patients with the following condition are excluded:

Unable or unwilling to comply with study procedures.

Concurrent Medication:

Excluded:

Chemoprophylactic therapy for mycobacterial infection.
Any nonstudy prescription medications without approval of investigator.

Patients with the following prior conditions are excluded:

History of grade 3 or 4 toxicity to <= 600 mg/day AZT.
History of intolerance to lactose.
Chronic diarrhea within 6 months prior to study entry.
Unexplained intermittent or chronic fever, defined as temperature >= 38.5 C for any 7 days within the 30 days prior to study entry.

Prior Medication:

Excluded:

Antiretroviral therapy within 2 weeks prior to study entry.
Prior HIV vaccines.
Biological response modifiers within 30 days prior to study entry.
Prior foscarnet.
Any investigational drug with a washout < 5 half-lives prior to study entry.
Any medications known to alter renal, hepatic, or hematologic / immunologic function (such as barbiturates, phenothiazines, cimetidine, immunomodulators, etc.) within 14 days prior to study entry.

Recent history of alcohol and/or drug abuse.