Anti-HIV Drug Regimens With or Without Protease Inhibitors and Drug Level Monitoring in HIV Infected Adolescents
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Acute Infection, Treatment Experienced, Treatment Naive
Eligibility 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
Sites / Locations
- Usc La Nichd Crs
- Long Beach Memorial Med. Ctr., Miller Children's Hosp.
- Children's Hospital of Los Angeles NICHD CRS
- Univ. of Colorado Denver NICHD CRS
- Chicago Children's CRS
- Tulane/LSU Maternal/Child CRS
- Children's Hosp.
- Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
- Bronx-Lebanon Hosp. IMPAACT CRS
- SUNY Stony Brook NICHD CRS
- St. Jude/UTHSC CRS
- Children's Med. Ctr. Dallas
- Texas Children's Hosp. CRS