Search / Trial NCT00002329

A Study of MDL 28,574A in HIV-Infected Patients

Launched by HOECHST MARION ROUSSEL · Aug 30, 2001

Trial Information

Current as of December 07, 2024

Completed

Keywords

Mdl 28574

ClinConnect Summary

In Part A of the study, patients receive a single oral dose of MDL 28574A on day 1 and are followed through day 7. In Part B, patients receive single daily doses of the drug on days 1 through 14 and are followed through day 21.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • Patients must have:
  • HIV infection.
  • CD4 count \>= 500 cells/mm3.
  • No evidence of AIDS.
  • No antiretroviral therapy within 30 days prior to study entry.
  • NOTE:
  • Presence of lymphadenopathy in two or more extrainguinal sites, at least 1 cm in diameter for 3 or more months, is permitted.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Clinically significant abnormalities on routine hematology (other than CD4 count and Western blot), serum chemistry, and urinalysis.
  • Abnormal EKG.
  • Positive stool guaiac.
  • Abnormal medical history or physical exam including temperature, heart rate, and blood pressure.
  • Clinically significant organ abnormality or disease.
  • Positive urine drug screen for illicit drugs.
  • Inability to comply with study procedures.
  • Concurrent Medication:
  • Excluded:
  • Routine treatment with nonprescription medications.
  • Treatment with other medications except with approval of the investigator.
  • Patients with the following prior conditions are excluded:
  • Prior participation in this trial.
  • Serious physical or mental illness within 1 year prior to study entry that would confound interpretation of data.
  • Prior Medication:
  • Excluded:
  • Antiretroviral therapy within 30 days prior to study entry.
  • Known medications that alter renal, hepatic, or hematologic/immunologic function (such as barbiturates, phenothiazines, cimetidine, and immunomodulators) within 14 days prior to study entry.
  • Routine treatment with nonprescription medications within 3 days prior to study entry.
  • History of alcohol or drug abuse within the past year.

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

San Francisco, California, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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