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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002150
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Information provided by:
NIH AIDS Clinical Trials Information Service

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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Celgosivir hydrochloride Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Masking: Double
Primary Purpose: Treatment
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 the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

Patients must have:

  • HIV infection.
  • Asymptomatic or mildly symptomatic.
  • CD4 count 100 - 300 cells/mm3.

Prior Medication:


  • 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:


  • 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:


  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002150

  Hide Study Locations
United States, Alabama
Clinical Investigations Health Services
Mobile, Alabama, United States, 366880002
United States, California
California Clinical Trials Med Group
Beverly Hills, California, United States, 90211
Southwest Community Based AIDS Treatment Group - COMBAT
Los Angeles, California, United States, 90027
UCSF - San Francisco Gen Hosp
San Francisco, California, United States, 94110
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
Independent Investigator
Fort Lauderdale, Florida, United States, 33316
North Broward Hosp District
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
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, United States, 752359103
Univ TX Galveston Med Branch
Galveston, Texas, United States, 775550835
Houston Clinical Research Network
Houston, Texas, United States, 77006
Sponsors and Collaborators
Hoechst Marion Roussel Identifier: NCT00002150     History of Changes
Other Study ID Numbers: 221B
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: March 1996

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

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