A Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients

June 23, 2005 updated by: Hoechst Marion Roussel
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alabama
      • Mobile, Alabama, United States, 366880002
        • Clinical Investigations Health Services
    • California
      • Beverly Hills, California, United States, 90211
        • California Clinical Trials Med Group
      • Los Angeles, California, United States, 90027
        • Southwest Community Based AIDS Treatment Group - COMBAT
      • San Francisco, California, United States, 94110
        • UCSF - San Francisco Gen Hosp
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • George Washington Univ / Hershey Med Ctr
    • Florida
      • Coral Gables, Florida, United States, 33146
        • Community Research Initiative of South Florida
      • Fort Lauderdale, Florida, United States, 33316
        • North Broward Hosp District
      • Fort Lauderdale, Florida, United States, 33316
        • Independent Investigator
      • Sarasota, Florida, United States, 34239
        • Clinical Research Ctr
      • Vero Beach, Florida, United States, 32960
        • Independent Investigator
    • Illinois
      • Chicago, Illinois, United States, 60657
        • Ctr for Special Immunology
    • Indiana
      • Indianapolis, Indiana, United States, 462025250
        • Indiana Univ Hosp
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Univ of Kansas School of Medicine
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Univ Health Ctr
    • Missouri
      • Kansas City, Missouri, United States, 64132
        • Antibiotic Research Associates
    • New Jersey
      • Newark, New Jersey, United States, 071032842
        • North Jersey Community Research Initiative
    • New York
      • Rochester, New York, United States, 14620
        • Community Health Network
      • Stony Brook, New York, United States, 117948153
        • SUNY / Health Sciences Ctr at Stony Brook
    • Ohio
      • Toledo, Ohio, United States, 43608
        • Infectious Disease Associates
    • Pennsylvania
      • Sayre, Pennsylvania, United States, 18840
        • Guthrie Clinic
    • Texas
      • Dallas, Texas, United States, 752359103
        • Univ of Texas Southwestern Med Ctr of Dallas
      • Galveston, Texas, United States, 775550835
        • Univ TX Galveston Med Branch
      • Houston, Texas, United States, 77006
        • Houston Clinical Research Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

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.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Masking: DOUBLE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (ESTIMATE)

August 31, 2001

Study Record Updates

Last Update Posted (ESTIMATE)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

March 1, 1996

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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