Evaluation of an Anti-HIV Drug Combination That Includes a Coated Form of Didanosine (ddI EC) Compared to a Typical Anti-HIV Drug Regimen

• Status: Completed
• Trial end date: 2001-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This study tests a new form of didanosine, ddI EC, a coated pill that passes through the stomach before dissolving. The purpose of this study is to compare the effectiveness of an anti-HIV drug combination that includes ddI EC versus another anti-HIV drug combination.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Didanosine; Lamivudine; Lamivudine, zidovudine drug combination; Nelfinavir; Stavudine; Zidovudine

Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

• Are HIV-positive.

• Have a viral load of at least 2,000 copies/ml and a CD4 count of at least 200 cells/mm3.

• Are at least 18 years old.

• Agree to practice sexual abstinence or to use effective barrier methods of birth control (such as condoms).

Exclusion Criteria

Patients will not be eligible for this study if they:

• Have had severe diarrhea within 30 days of study entry.

• Have a history of pancreatic disease or any other serious condition.

• Have hepatitis within 30 days of study entry.

• Are diagnosed with an opportunistic (AIDS-related) infection at the time of enrollment.

• Are unable to take medications by mouth.

• Have received certain medications.

• Are pregnant or breast-feeding.