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A Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients
This study has been completed.
First Received: November 2, 1999   Last Updated: June 23, 2005   History of Changes
Sponsor: Hoechst Marion Roussel
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002150
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Celgosivir hydrochloride
Phase II

Study Type: Interventional
Study Design: Treatment, Double-Blind, Safety Study
Official Title: A Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 200
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002150

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

No publications provided

Study ID Numbers: 221B, 028574PR0003, NDPR0003
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00002150     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Zidovudine
MDL 28574

Additional relevant MeSH terms:
Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on November 27, 2009