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

• Status: Completed
• Trial end date: 1999-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Didanosine

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.