Differences in Malaria Infection Levels in HIV-infected Infants and Children Receiving PI- and NNRTI-based HAART

• Parasitemia in blood samples [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  

• Time of initiation of treatment for clinical malaria requiring conventional anti-malarial therapy [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  
• Severity of malarial disease [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
  
• Measured anti-malaria IgG, protein in plasma, and mRNA transcripts in PBMC of chemokines [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  
• IL4-589C/T genotypes [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  

The World Health Organization (WHO) reports 1 to 2 million malaria deaths annually, with most malaria-related deaths occurring in children. The malaria burden is compounded by the HIV epidemic, which is most prevalent in areas endemic for malaria, notably Sub-Saharan Africa where nine in ten children younger than 15 years of age are infected with HIV. The purpose of this study is to compare parasitemia levels in HIV-infected infants and children receiving PI- or NNRTI-based HAART regimens.

This study will enroll a total of 140 participants, 35 from each of the 4 groups in IMPAACT P1060.

This substudy will last until 24 weeks after the last P1060 enrollment or until P1060 study discontinuation. Participants must meet enrollment criteria for P1060 as well as additional criteria for this study. Study visits will occur as a part of P1060 study visits, all of which include a physical exam, blood collection, and assessments of HIV-related symptoms.

Participants are also encouraged to return to the primary clinic site for intercurrent illness visits for assessment, thick and thin blood smear, and filter paper blood collection, however these visits are not mandatory for study participation.