A Study Comparing Two Forms of Didanosine in HIV-Infected Patients - Tabular View

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A Study Comparing Two Forms of Didanosine in HIV-Infected Patients

This study has been completed.

Study NCT00002360. Last updated on August 15, 2007. Information provided by Bristol-Myers Squibb

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

Descriptive Information Fields

Brief Title ^†

A Study Comparing Two Forms of Didanosine in HIV-Infected Patients

Official Title ^†

Pivotal Bioequivalence Study of Videx Chewable/Dispersible Buffered Tablets and an Encapsulated Enteric Coated Bead Formulation of Didanosine in HIV-Infected Subjects

Brief Summary

The purpose of this study is to see if the coated-capsule form of didanosine (ddI) is as safe and absorbed by the body as well as the chewable-tablet form of ddI.

Didanosine (ddI) is an anti-HIV drug. The effectiveness of ddI can be lowered by acid in the stomach. To prevent this, patients take antacids with ddI. The coated-capsule form of ddI may replace the need for antacids.

Detailed Description

Didanosine, a purine nucleoside analogue, is indicated for the treatment of HIV infection when antiretroviral therapy is warranted. Didanosine is administered orally with antacids to protect it against acid-induced hydrolysis in the stomach. To eliminate the need for using buffers in the ddI formulations, an enteric-coated bead formulation of ddI is being developed.

Patients are randomized to 1 of 2 groups to receive treatment on 2 separate occasions at least 72 hours apart. Group 1 receives the reference formulation of ddI. Group 2 receives the test formulation of ddI. Clinical evaluations, including clinical laboratory tests, are performed periodically during the study and at discharge. Serial blood samples are collected at specific time points over the 12 hours following dosing, and are used for the pharmacokinetic variables CMAX and AUC(INF). Factors used in analysis are sequence, subject within sequence, period, and formulation. Safety is assessed by monitoring adverse effects, vital signs, ECG recordings, and clinical laboratory tests throughout the study.

Study Phase

Phase I

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety Study

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

HIV Infections

Intervention ^†

Drug: Didanosine

MEDLINE PMIDs

Links

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

March 1999

Completion Date

March 1999

Eligibility Criteria ^†

Inclusion Criteria

Patients must have:

HIV infection.
CD4 cell counts of at least 200 cells/mm3.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

Any evidence of organ dysfunction.
Any clinically significant deviations from specified baseline requirements for physical examinations, laboratory tests, or 12-lead electrocardiogram.

Gender

Both

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Administrative Information Fields

NCT ID ^†

NCT00002360

Organization ID

039H

Secondary IDs ^††

31876, AI454-157

Study Sponsor ^†

Bristol-Myers Squibb

Collaborators ^††

Investigators ^†

Study Director:

Catherine A. Knupp

Information Provided By

Bristol-Myers Squibb

Verification Date

August 2007

First Received Date ^†

November 2, 1999

Last Updated Date

August 15, 2007

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