When to Start Anti-HIV Drugs in Children Infected With HIV (The PREDICT Study)
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Treatment Naive, Treatment Initiation, Infant, Preschool Child, Child, Zidovudine, AZT, Retrovir, 3TC, Lamivudine, Epivir, Nevirapine, NVP, Viramune, Efavirenz, EFV, Sustiva, Lopinavir/Ritonavir, LPV/r, Kaletra, Nelfinavir, NFV, Viracept, ABC, Abacavir, Ziagen
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Sites / Locations
- National Pediatric Hosp., Cambodia CIPRA CRS
- Social Health Clinic, Cambodia CIPRA CRS
- Hiv-Nat Cipra Crs
- Chiang Rai Regional Hosp. CIPRA CRS
- Prapokklao Hosp. CIPRA CRS
- Nakornping Hosp. CIPRA CRS
- Queen Savang Vadhana Memorial Hosp. CIPRA CRS
- Srinagarind Hosp. CIPRA CRS
- Bamrasnaradura Institute CIPRA CRS
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
1
2
Immediate treatment; individuals receive HAART on Day 1 of the study
Delayed treatment; individuals receive HAART if their CD4 percentage falls below 15 percentage OR if they develop a CDC category C illness