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

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00002329 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Study of MDL 28,574A in HIV-Infected Patients
Official Title ^ICMJE	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 ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Double-Blind, Pharmacokinetics Study
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: Celgosivir hydrochloride
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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 ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00002329
Responsible Party
Study ID Numbers ^ICMJE	221A, NDPR0002
Study Sponsor ^ICMJE	Hoechst Marion Roussel
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	May 1995
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP