A Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients
3 other identifiers
interventional
200
1 country
23
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 hiv-infections
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
March 1, 1996
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients must have:
- HIV infection.
- Asymptomatic or mildly symptomatic.
- CD4 count 100 - 300 cells/mm3.
- Prior Medication:
- Allowed:
- Prior antiretroviral agents for up to 6 months per agent.
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.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Clinical Investigations Health Services
Mobile, Alabama, 366880002, United States
California Clinical Trials Med Group
Beverly Hills, California, 90211, United States
Southwest Community Based AIDS Treatment Group - COMBAT
Los Angeles, California, 90027, United States
UCSF - San Francisco Gen Hosp
San Francisco, California, 94110, United States
George Washington Univ / Hershey Med Ctr
Washington D.C., District of Columbia, 20037, United States
Community Research Initiative of South Florida
Coral Gables, Florida, 33146, United States
Independent Investigator
Fort Lauderdale, Florida, 33316, United States
North Broward Hosp District
Fort Lauderdale, Florida, 33316, United States
Clinical Research Ctr
Sarasota, Florida, 34239, United States
Independent Investigator
Vero Beach, Florida, 32960, United States
Ctr for Special Immunology
Chicago, Illinois, 60657, United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250, United States
Univ of Kansas School of Medicine
Wichita, Kansas, 67214, United States
Univ Health Ctr
Detroit, Michigan, 48201, United States
Antibiotic Research Associates
Kansas City, Missouri, 64132, United States
North Jersey Community Research Initiative
Newark, New Jersey, 071032842, United States
Community Health Network
Rochester, New York, 14620, United States
SUNY / Health Sciences Ctr at Stony Brook
Stony Brook, New York, 117948153, United States
Infectious Disease Associates
Toledo, Ohio, 43608, United States
Guthrie Clinic
Sayre, Pennsylvania, 18840, United States
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 752359103, United States
Univ TX Galveston Med Branch
Galveston, Texas, 775550835, United States
Houston Clinical Research Network
Houston, Texas, 77006, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1996-03