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

June 23, 2005 updated by: Hoechst Marion Roussel

A Randomized, Placebo-Controlled, Double-Blind, Single and Multiple Oral Dose-Tolerance Study of Oral MDL 28,574A Solution in HIV-Positive Patients

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94109
        • Saint Francis Mem Hosp

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoechst Marion Roussel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 2, 1999

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2001

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2005

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2005

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 1995

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 221A
  • NDPR0002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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