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

Overview

To characterize the safety and efficacy of fixed doses of MDL 28,574A administered alone and in combination with zidovudine ( AZT ) in patients with asymptomatic or mildly symptomatic HIV infection. To examine the demographic effects on population pharmacokinetics and pharmacodynamics of MDL 28,574A alone and in combination with AZT.

Study Type

  • Study Type: Interventional
  • Study Design
    • Primary Purpose: Treatment
    • Masking: Double

Interventions

  • Drug: Celgosivir hydrochloride

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hoechst Marion Roussel

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