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

Launched by HOECHST MARION ROUSSEL · Aug 30, 2001

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• • 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.