A Randomized, Double-Blind Active-Controlled, Dose-Ranging Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients

Launched by HOECHST MARION ROUSSEL · Aug 30, 2001

Keywords

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Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Concurrent Medication:
• Allowed:
• • Prior antiretroviral agents for up to 6 months per agent.
• Patients must have:
• • HIV infection.
• • Asymptomatic or mildly symptomatic.
• • CD4 count 301 - 500 cells/mm3.
• • 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.