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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002329
• Other study ID #: 221A
• Secondary ID: NDPR0002
• Status: Completed
• Phase: Phase 1
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: May 1995
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Endpoint Classification: Pharmacokinetics Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Celgosivir hydrochloride

Locations

Country	Name	City	State
United States	Saint Francis Mem Hosp	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Hoechst Marion Roussel

Country where clinical trial is conducted

United States,