Status:
COMPLETED
Anti-HIV Drug Regimens With or Without Protease Inhibitors and Drug Level Monitoring in HIV Infected Adolescents
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
HIV Infections
Eligibility:
All Genders
13-23 years
Phase:
PHASE3
Brief 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 lev...
Detailed Description
HIV infected adolescents may have a significantly higher capacity for immune reconstitution following highly active antiretroviral therapy (HAART), compared to adults. Despite this advantage, HIV infe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
End Date :
September 1 2006
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00075907
Start Date
July 1 2004
End Date
September 1 2006
Last Update
October 7 2013
Active Locations (13)
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1
Usc La Nichd Crs
Alhambra, California, United States, 91803
2
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, United States, 90806
3
Children's Hospital of Los Angeles NICHD CRS
Los Angeles, California, United States, 90027
4
Univ. of Colorado Denver NICHD CRS
Aurora, Colorado, United States, 80045