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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 | Clinical Trials | Clareo Health

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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

NCT00002151•Hoechst Marion Roussel

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+11 more criteria

Locations (24)

Clinical Investigations Health Services

Mobile, Alabama, United States

California Clinical Trials Med Group

Beverly Hills, California, United States

Southwest Community Based AIDS Treatment Group - COMBAT

Los Angeles, California, United States

UCSF - San Francisco Gen Hosp

San Francisco, California, United States

George Washington Univ / Hershey Med Ctr

Washington D.C., District of Columbia, United States

Community Research Initiative of South Florida

Coral Gables, Florida, United States

Independent Investigator

Fort Lauderdale, Florida, United States

North Broward Hosp District

Fort Lauderdale, Florida, United States

Clinical Research Ctr

Sarasota, Florida, United States

Independent Investigator

Vero Beach, Florida, United States

Key Dates

Last Updated

June 24, 2005

Enrollment

200

Estimated participants

Conditions

HIV Infections

Interventions

Celgosivir hydrochloride

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 24, 2005Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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