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
NCT ID: NCT00002151
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
200 participants
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
DOUBLE
Interventions
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Celgosivir hydrochloride
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Hoechst Marion Roussel
INDUSTRY
Locations
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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
Countries
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Other Identifiers
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028574PR0004
Identifier Type: -
Identifier Source: secondary_id
NDPR0004
Identifier Type: -
Identifier Source: secondary_id
221C
Identifier Type: -
Identifier Source: org_study_id