When to Start Anti-HIV Drugs in Children Infected With HIV (The PREDICT Study)
Condition: HIV Infections
MeSH terms: Infections; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 3

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 of HIV infected children 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 for HIV infected children.

      This study will last 144 weeks. All participants will have a CD4 percentage (CD4%) between
      15% and 24% and will be randomly assigned to either receive immediate or delayed HAART. The
      HAART regimen will consist of two nucleoside reverse transcriptase inhibitors, zidovudine and
      lamivudine. In addition, participants will also receive either one non-nucleoside reverse
      transcriptase inhibitor, nevirapine or efavirenz, or one protease inhibitor,
      ritonavir-boosted lopinavir or nelfinavir. Abacavir will replace zidovudine or lamivudine if
      participants experience toxicity 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
      reviews will occur at all visits. Adherence, quality of life, and lipodystrophy assessments
      will occur every 12 weeks for participants on HAART. Participants will be encouraged to
      enroll in a related substudy to examine the neurodevelopment of HIV infected children.
    

Intervention name(s): Abacavir; Efavirenz; Lamivudine; Lopinavir/Ritonavir; Nelfinavir; Nevirapine; Zidovudine
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 8 mg/kg (up to 300 mg/dose) take orally twice daily; 200 to 600 mg taken orally once daily; 4 mg/kg (up to 150 mg/dose) taken orally twice daily; 230 mg/57.5 mg/m^2 body surface area taken orally twice daily with food; 45-55 mg/kg taken orally twice daily with food; 120 mg/m^2 once daily for first 14 days, tehn 200 mg/m^2 (up to 400 mg/day) twice daily; 180-240 mg/m^2 every 12 hours (up to 300 mg/dose)
Intervention MeSH terms: Ritonavir; Lopinavir; Nelfinavir; Lamivudine; Zidovudine; Nevirapine; Abacavir; Efavirenz
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: 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