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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Celgosivir hydrochloride
Sponsored by
Hoechst Marion Roussel
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring MDL 28574

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Saint Francis Mem Hosp

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Hoechst Marion Roussel
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1. Study Identification

Unique Protocol Identification Number
NCT00002329
Brief Title
A Study of MDL 28,574A in HIV-Infected Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 1995
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Hoechst Marion Roussel

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
MDL 28574

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Masking
Double

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Celgosivir hydrochloride

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Saint Francis Mem Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States

12. IPD Sharing Statement

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

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