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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002151
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: March 1996
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

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

Concurrent Medication:

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002151

  Hide Study Locations
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
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, Kansas
Univ of Kansas School of Medicine
Wichita, Kansas, United States, 67214
United States, Louisiana
New Orleans Institute of Clinical Investigation
New Orleans, Louisiana, United States, 70112
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, Oregon
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, United States, 97210
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002151     History of Changes
Other Study ID Numbers: 221C, 028574PR0004, NDPR0004
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on July 22, 2014