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

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

This study has been completed.

Study NCT00002329. Last updated on June 23, 2005. Information provided by NIH AIDS Clinical Trials Information Service

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
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
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.
Study Phase	Phase I
Study Type ^†	Interventional
Study Design ^†	Treatment, Double-Blind, Pharmacokinetics Study
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	HIV Infections
Intervention ^†	Drug: Celgosivir hydrochloride
MEDLINE PMIDs
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Recruitment Information Fields
Recruitment Status ^†	Completed
Enrollment ^†
Start Date ^†
Completion Date
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.
Gender	Both
Ages	18 Years to 50 Years
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States

Administrative Information Fields
NCT ID ^†	NCT00002329
Organization ID	221A
Secondary IDs ^††	NDPR0002
Study Sponsor ^†	Hoechst Marion Roussel
Collaborators ^††
Investigators ^†
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	May 1995
First Received Date ^†	November 2, 1999
Last Updated Date	June 23, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.