Anti-HIV Drug Regimens With or Without Protease Inhibitors and Drug Level Monitoring in HIV Infected Adolescents

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the effectiveness of anti-HIV drug regimens with or without a protease inhibitor (PI) in HIV infected adolescents. It will also determine if monitoring drug levels and adjusting the dose as necessary improves the effectiveness of these regimens.

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

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Efavirenz; Lopinavir; Protease Inhibitors; Ritonavir

Criteria

Inclusion Criteria:

• HIV infected

• HIV RNA viral load of 10,000 copies/ml or more at screening

• Weigh 35 kg (77.2 lbs) or more

• HAART naive or received a single regimen of combination therapy consisting of NRTIs with or without a single PI (except LPV). Patients who received zidovudine monotherapy during pregnancy or used low-dose ritonavir (RTV) as a PI boost are not excluded.

• For PI experienced patients, have sensitivity to LPV at screening

• Able to receive, as part of background HAART chosen by their physician, at least one new NRTI that is likely to be active against the patient's virus and unlikely to have cross-resistance with previously used NRTIs

• Willing to use acceptable forms of contraception

• Parent or legal guardian willing to provide informed consent, if applicable

Exclusion Criteria:

• Prior receipt of any NNRTI or LPV

• Require certain medications

• Grade 3 or 4 clinical or laboratory toxicity, as defined by the Division of AIDS Toxicity Table for Grading Severity of Pediatric Adverse Effects

• Chemotherapy for active malignancy

• Acute opportunistic or serious bacterial infection requiring therapy at study entry

• Investigational treatment within 30 days of study entry

• Score of 20 or more on Beck Depression Inventory (BDI-II) or suicidal thoughts on BDI-II (score of 2 or 3 on Question 9), regardless of total score

• Pregnant within 48 hours of starting EFV

• Breastfeeding