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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002329
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
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.
Information provided by:
NIH AIDS Clinical Trials Information Service
  Purpose
To characterize the safety profile of MDL 28574A following both acute and subchronic dosing in HIV-positive patients. To determine the MTD of both acute and subchronic doses of this drug when administered as oral solution. To determine the pharmacokinetic profile of MDL 28574A and castanospermine (from which MDL 28574A is derived) following both acute and subchronic dosing.

Condition Intervention Phase
HIV Infections Drug: Celgosivir hydrochloride Phase 1

Study Type: Interventional
Study Design: Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled, Double-Blind, Single and Multiple Oral Dose-Tolerance Study of Oral MDL 28,574A Solution in HIV-Positive Patients

Resource links provided by NLM:


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

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00002329


Locations
United States, California
Saint Francis Mem Hosp
San Francisco, California, United States, 94109
Sponsors and Collaborators
Hoechst Marion Roussel
  More Information

ClinicalTrials.gov Identifier: NCT00002329     History of Changes
Other Study ID Numbers: 221A
NDPR0002
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
Last Verified: May 1995

Keywords provided by NIH AIDS Clinical Trials Information Service:
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