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

Launched by BRISTOL-MYERS SQUIBB · Aug 30, 2001

Keywords

ClinConnect Summary

Patients are randomized to 1 of 2 groups for 48 weeks of open-label treatment. Group 1 receives ddI EC plus d4T plus NFV. Group 2 receives Combivir plus NFV. Antiviral activity is determined by the proportion of patients with HIV RNA levels of less than 400 copies/ml at Week 48.

Gender

ALL

Eligibility 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.