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

Hoechst Marion Roussel

Status and phase: Completed; Phase 2

Conditions: HIV Infections

Treatments: Drug: Celgosivir hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002151

028574PR0004

221C

NDPR0004

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.