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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.
Information provided by:
NIH AIDS Clinical Trials Information Service Identifier:
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: March 1996
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: Masking: Double-Blind
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 NLM:

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

Estimated Enrollment: 200

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.

  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 identifier: NCT00002150

  Show 23 Study Locations
Sponsors and Collaborators
Hoechst Marion Roussel
  More Information Identifier: NCT00002150     History of Changes
Other Study ID Numbers: 221B
Study First Received: November 2, 1999
Last Updated: June 23, 2005

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 processed this record on May 25, 2017