Safety, Tolerability, and Anti-HIV Activity of DMP 266 (Efavirenz) in Combination With Nelfinavir in HIV-Positive Children

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

The demonstrated antiviral activity, tolerability, and pharmacokinetic properties of DMP 266 and its utility in combination with other agents make DMP 266 an attractive agent for use in HIV-infected pediatric patients. However, the tolerability of DMP 266 in the pediatric population must be evaluated, and appropriate dosing instructions need to be developed. By following the patients over time, the antiviral activity of DMP 266-containing regimens will be documented. Dosage guidelines for children can then be developed following analysis of the results.

This is a 48-week \[AS PER AMENDMENT...

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Children may be eligible for this study if they:
• • Are HIV-positive.
• • Are between 3 months and 16 years old (consent of parent or legal guardian required). (These age requirements reflect a change.)
• • Have a plasma viral load of at least 400 copies/ml at screening.
• • Agree to practice abstinence or use effective methods of birth control during the study.
• • Are able to take oral medication and comply with study requirements.
• • Are taking at least 1 nucleoside reverse transcriptase inhibitor (NRTI), such as zidovudine (ZDV) or stavudine (d4T). Patients can begin taking NRTIs at the beginning of the study.
• • Exclusion Criteria
• Children will not be eligible for this study if they:
• • Have had more than 2 episodes of moderate to severe diarrhea or vomiting lasting more than 4 days within 3 months prior to study entry.
• • Are allergic to EFZ or NFV.
• • Have any disease, including hepatitis, cancer, or an active opportunistic (HIV-associated) infection.
• • Are pregnant or breast-feeding.
• • Are taking any other experimental drugs or certain medications.
• • Have ever taken protease inhibitors (PIs) or nonnucleoside reverse transcriptase inhibitors (NNRTIs).