Search / Trial NCT00002150

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

Launched by HOECHST MARION ROUSSEL · Aug 30, 2001

Trial Information

Current as of December 27, 2024

Completed

Keywords

Drug Therapy, Combination Acquired Immunodeficiency Syndrome Aids Related Complex Zidovudine Mdl 28574

ClinConnect Summary

No description provided

Gender

ALL

Eligibility 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.

About Hoechst Marion Roussel

Hoechst Marion Roussel, a prominent global pharmaceutical company, specializes in the research, development, and commercialization of innovative therapies across various therapeutic areas, including oncology, cardiovascular, and infectious diseases. With a commitment to advancing medical science and improving patient outcomes, the company leverages cutting-edge technology and a robust pipeline of clinical trials to bring new treatments to market. Hoechst Marion Roussel is dedicated to adhering to the highest ethical standards and regulatory guidelines, ensuring the safety and efficacy of its products while fostering collaboration with healthcare professionals and research institutions worldwide.

Locations

Sayre, Pennsylvania, United States

Indianapolis, Indiana, United States

Houston, Texas, United States

San Francisco, California, United States

Newark, New Jersey, United States

Wichita, Kansas, United States

Galveston, Texas, United States

Dallas, Texas, United States

Washington, District Of Columbia, United States

Fort Lauderdale, Florida, United States

Stony Brook, New York, United States

Los Angeles, California, United States

Rochester, New York, United States

Chicago, Illinois, United States

Coral Gables, Florida, United States

Mobile, Alabama, United States

Beverly Hills, California, United States

Fort Lauderdale, Florida, United States

Sarasota, Florida, United States

Vero Beach, Florida, United States

Detroit, Michigan, United States

Kansas City, Missouri, United States

Toledo, Ohio, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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