The purpose of this study is to determine when children infected with HIV should begin taking anti-HIV medications in order to improve both patient quality of life and survival.

Condition	Intervention	Phase
HIV Infections	Drug: Zidovudine  Drug: Lamivudine  Drug: Nevirapine  Drug: Efavirenz  Drug: Lopinavir/Ritonavir  Drug: Nelfinavir  Drug: Abacavir	Phase III

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcomes: AIDS-free survival at Week 144
Secondary Outcomes: Direct and indirect cost of treatment per patient; number and duration of hospitalizations; time to and number of grades 3 or 4 HAART-related toxicity and intolerance; number of HAART regimen changes; number of grades 1 or 2 infectious episodes; number of courses of antibiotics used; number of HIV-related clinical events; virologic failure, defined as HIV RNA viral load of 1000 copies/ml or more after 24 weeks of HAART; presence of a resistance mutation in participants with virologic failure; change of growth in Z scores from baseline to Week 144; change in CD4% from baseline to Week 144 and time-weighted average change from baseline over 144 weeks; CD4 less than 10% at Week 144; average scores of quality of life over time; adherence to HAART over time; presence of iron deficiency anemia; HIV viral sequence; HIV viral replication capacity; CTL response; percentage of different T cell subsets
Expected Total Enrollment:  300

The use of highly active antiretroviral therapy (HAART) has resulted in a significant reduction in AIDS-related deaths and complications among adults and adolescents. However, the medical management of children infected with HIV remains challenging. Access to HIV treatment is limited and early treatment initiation can cause serious complications. Since there is currently no cure for HIV, a balance between treating the disease and maintaining quality of life must be weighed carefully. An evaluation to determine the appropriate time to initiate HAART is necessary to improve both quality of life and survival in children infected with HIV.

This study will last 144 weeks. All participants will have a CD4 cell percentage between 15 and 24 percent, and will be randomly assigned to either receive immediate or delayed HAART. The HAART regimen will consist of 2 nucleoside reverse transcriptase inhibitors (NRTIs), zidovudine and lamivudine, with either 1 nonnucleoside reverse transcriptase inhibitor (NNRTI), nevirapine or efavirenz, or 1 protease inhibitor (PI), ritonavir-boosted lopinavir (lopinavir/r) or nelfinavir. Abacavir will replace zidovudine or lamivudine if participants expereince toxicty to the regimen. Participants in the immediate treatment arm will receive HAART on Day 1 of the study regardless of their CD4%. Participants in the delayed treatment arm will receive HAART if their CD4% falls below 15 or if they develop a CDC category C illness.

Study visits will occur every 4 weeks for the first 12 weeks and then every 12 weeks until the end of the study. Blood collection, physical exams, and medical and medication history updates will occur at all visits. Adherence, quality of life, and lipodystrophy assessments will occur every 12 weeks for participants on HAART.

Ages Eligible for Study:  1 Year   -   12 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• HIV-1 infected
• Antiretroviral naive, defined as never receiving antiretroviral medications, receiving them for less than 7 days, or only receiving them to prevent mother-to-child transmission (PMTCT)
• CD4% between 15 and 24 within 30 days prior to study entry
• Legal guardian or parent willing to provide informed consent and to follow all study procedures and requirements

Exclusion Criteria:

• Use of certain medications within 30 days prior to study entry
• Active AIDS-defining illnesses (CDC Category C) within 30 days prior to study entry
• Pregnancy
• Known kidney insufficiency
• Known allergy or sensitivity to study drugs

Please refer to this study by ClinicalTrials.gov identifier  NCT00234091

Study chairs or principal investigators

Kiat Ruxrungtham, MD, MPH,  Study Chair,  Department of Medicine at Chulalongkorn University, Bangkok, Thailand   
Saphonn Vonthanak, MD, PhD,  Study Chair,  National Center for HIV/AIDS, Dermatology and STDs, Phnom Penh, Cambodia   

Study ID Numbers:  CIPRA TH001; PREDICT
Last Updated:  December 8, 2005
Record first received:  October 4, 2005
ClinicalTrials.gov Identifier:  NCT00234091
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2006-01-10