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

Completed · Phase 3

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00075907

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

240

Starts

2004-07-01

Expected to finish

2006-09-01

Last updated by the study team

2013-10-07

Who can join

Age: 13 and older, up to 23. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Usc La Nichd Crs — Alhambra, California, United States
• Long Beach Memorial Med. Ctr., Miller Children's Hosp. — Long Beach, California, United States
• Children's Hospital of Los Angeles NICHD CRS — Los Angeles, California, United States
• Univ. of Colorado Denver NICHD CRS — Aurora, Colorado, United States
• Chicago Children's CRS — Chicago, Illinois, United States
• Tulane/LSU Maternal/Child CRS — New Orleans, Louisiana, United States
• Children's Hosp. — New Orleans, Louisiana, United States
• Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases — Baltimore, Maryland, United States
• SUNY Stony Brook NICHD CRS — Stony Brook, New York, United States
• Bronx-Lebanon Hosp. IMPAACT CRS — The Bronx, New York, United States
• St. Jude/UTHSC CRS — Memphis, Tennessee, United States
• Children's Med. Ctr. Dallas — Dallas, Texas, United States
• Texas Children's Hosp. CRS — Houston, Texas, United States

Full record on ClinicalTrials.gov

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