A Study of MDL 28,574A in HIV-Infected Patients

In Part A of the study, patients receive a single oral dose of MDL 28574A on day 1 and are followed through day 7. In Part B, patients receive single daily doses of the drug on days 1 through 14 and are followed through day 21.

Inclusion criteria

Patients must have:

• HIV infection.
• CD4 count >= 500 cells/mm3.
• No evidence of AIDS.
• No antiretroviral therapy within 30 days prior to study entry.

NOTE:

• Presence of lymphadenopathy in two or more extrainguinal sites, at least 1 cm in diameter for 3 or more months, is permitted.

Exclusion criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Clinically significant abnormalities on routine hematology (other than CD4 count and Western blot), serum chemistry, and urinalysis.
• Abnormal EKG.
• Positive stool guaiac.
• Abnormal medical history or physical exam including temperature, heart rate, and blood pressure.
• Clinically significant organ abnormality or disease.
• Positive urine drug screen for illicit drugs.
• Inability to comply with study procedures.

Concurrent Medication:

Excluded:

• Routine treatment with nonprescription medications.
• Treatment with other medications except with approval of the investigator.

Patients with the following prior conditions are excluded:

• Prior participation in this trial.
• Serious physical or mental illness within 1 year prior to study entry that would confound interpretation of data.

Prior Medication:

Excluded:

• Antiretroviral therapy within 30 days prior to study entry.
• Known medications that alter renal, hepatic, or hematologic/immunologic function (such as barbiturates, phenothiazines, cimetidine, and immunomodulators) within 14 days prior to study entry.
• Routine treatment with nonprescription medications within 3 days prior to study entry.

History of alcohol or drug abuse within the past year.