Status:
COMPLETED
When to Start Anti-HIV Drugs in Children Infected With HIV (The PREDICT Study)
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Comprehensive International Program of Research on AIDS
Conditions:
HIV Infections
Eligibility:
All Genders
1-12 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine when HIV infected children should begin taking anti-HIV medications in order to improve both patient quality of life and survival.
Detailed Description
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 o...
Eligibility Criteria
Inclusion
- HIV-1 infected
- Antiretroviral naive, defined as never receiving anti-HIV medications, receiving them for less than 7 days, or only receiving them to prevent mother-to-child transmission (MTCT)
- CD4% between 15 and 24 within 30 days prior to study entry
- CDC pediatric clinical classification A or B
- Parent or guardian willing to provide informed consent and willing to follow all study procedures and requirements
Exclusion
- Use of systemic chemotherapy, immunomodulators, HIV vaccines, immune globulin, interleukins, or interferons within 30 days prior to study entry
- Active AIDS-defining illnesses (CDC Category C) within 30 days prior to study entry
- Certain abnormal laboratory values
- Known kidney disease
- Known allergy or sensitivity to study drugs
- Require certain medications
- Pregnancy
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00234091
Start Date
April 1 2006
End Date
September 1 2011
Last Update
December 4 2013
Active Locations (9)
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1
National Pediatric Hosp., Cambodia CIPRA CRS
Phnom Penh, Cambodia
2
Social Health Clinic, Cambodia CIPRA CRS
Phnom Penh, Cambodia
3
Hiv-Nat Cipra Crs
Pathumwan, Bangkok, Thailand, 10330
4
Chiang Rai Regional Hosp. CIPRA CRS
Muang, Changwat Chiang Rai, Thailand, 57000