Safety, Tolerability and Pharmacokinetics of Efavirenz in HIV-Infected Children

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of this study is to find the dose of Efavirenz for young children. The safety and how the medication is tolerated will also be studied.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Didanosine; Efavirenz; Emtricitabine

Criteria

Inclusion Criteria:

• HIV-1 infected; >=3 months of age to <=6 years of age (at time of treatment); screening plasma viral load >=1000 copies/mL

Exclusion Criteria:

• Genotypic or phenotypic resistance to EFV, ddl, or FTC/lamivudine (3TC) at screening