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

Completed · Phase 2

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00002151

Run by

Hoechst Marion Roussel

People needed

200

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• Ctr for Special Immunology — Chicago, Illinois, United States
• Univ of Kansas School of Medicine — Wichita, Kansas, United States
• New Orleans Institute of Clinical Investigation — New Orleans, Louisiana, United States
• Univ Health Ctr — Detroit, Michigan, United States
• Antibiotic Research Associates — Kansas City, Missouri, United States
• North Jersey Community Research Initiative — Newark, New Jersey, United States
• Community Health Network — Rochester, New York, United States
• SUNY / Health Sciences Ctr at Stony Brook — Stony Brook, New York, United States
• Infectious Disease Associates — Toledo, Ohio, United States
• Portland Veterans Adm Med Ctr / Rsch & Education Grp — Portland, Oregon, United States
• Guthrie Clinic — Sayre, Pennsylvania, United States
• Univ of Texas Southwestern Med Ctr of Dallas — Dallas, Texas, United States
• Univ TX Galveston Med Branch — Galveston, Texas, United States
• Houston Clinical Research Network — Houston, Texas, United States

Full record on ClinicalTrials.gov

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