HIV Protease Inhibitors for the Prevention of Malaria in Ugandan Children
Status:
Completed
Trial end date:
2013-01-01
Target enrollment:
Participant gender:
Summary
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 protease inhibitor (PI) - based antiretroviral therapy (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 insecticide-treated bed nets (ITN) and TS. This study will compare two
different ART regimens. Children enrolled in the study will start or continue to receive
either standard Ugandan first line treatment ART regimen (NNRTI+2 NRTIs) or an ART regimen
containing the HIV protease inhibitor (lopinavir/ritonavir +2 NRTIs) and followed for a
period of 24 months.
Phase:
Phase 3
Details
Lead Sponsor:
University of California, San Francisco
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)