PROMOTE PEDIATRICS

A RANDOMISED OPEN LABEL TRIAL OF HIV PROTEASE INHIBITORS FOR THE PREVENTION OF MALARIA IN HIV-INFECTED CHILDREN

ClinicalTrials.gov Identifier: NCT00978068

Screening and enrolling into the study began in September, 2009 and follow up is expected to continue until January, 2013.  

Recent press for this study can be found at the NIH News, Science Now, and Science Speaks.  


HIV and malaria are major causes of morbidity and mortality in Sub-Saharan Africa and children bear the greatest brunt of both diseases. No single existing intervention is likely to control malaria in Africa. Rather, improvements in malaria prevention are likely to come from strategies that employ multiple proven interventions targeting different populations. HIV-infected children represent one of the most vulnerable subpopulations in these countries. It is possible that the use of PI-based ART in HIV-infected children living in areas of high malaria transmission could prevent malaria in this vulnerable population. An effective remedy that offers the possibility to further reduce malaria risk, such as PIs, is highly desirable. This study will determine whether a PI based ART regimen will reduce malaria among children living in a malaria endemic area of Uganda and receiving an insecticide treated bed net and septrin.
Screening and enrolling into the study began in September, 2009 and follow up is expected to continue until January, 2013.  

The study aims are:

Specific Aim 1. To compare the incidence of malaria among HIV-infected children randomized to receive PI- vs. NNRTI-based ART. 300 HIV-infected children aged 6 months to 5 years meeting standard criteria for ART-initiation will be randomized to receive either a PI or NNRTI-based ART regimen and followed for 24 months. We hypothesize that HIV-infected children treated with PI-based ART will have a lower incidence of malaria compared to children receiving an NNRTI-based regimen. Secondary outcomes will include comparisons of the incidence of complicated malaria, the prevalences of anemia and asymptomatic parasitemia, and response to antimalarial therapy.

Specific Aim 2. To compare the safety and tolerance of PI- vs. NNRTI-based ART in HIV-infected children. The safety and tolerance of ARTs will be assessed using standardized algorithms that we have optimized in prior studies in Uganda. We hypothesize that the incidence of adverse events of > grade 2 severity in children who receive PI-based ART will not be inferior to those receiving NNRTI-based ART. Secondary outcomes will include comparisons of the incidence of serious adverse events, and the risk of discontinuation of assigned ART regimens.

Specific Aim 3. To compare the virologic, immunologic and clinical efficacy of PI-based versus NNRTI-based ART in children including:

  • Prevalence of HIV RNA suppression of <400 copies/mL at 24 and 48 weeks
  • Change in CD4 cell counts and % CD4 from ART initiation at 24 and 48 weeks
  • Development of one or more antiretroviral resistance mutations at 48 weeks
  • Development of WHO stage 2,3 or 4 event at 48 weeks