In-Vivo Response of P. Falciparum to Antimalarial Treatment in HIV-Infected and HIV-Uninfected Adults
Status:
Completed
Trial end date:
2004-07-01
Target enrollment:
Participant gender:
Summary
Plasmodium falciparum malaria and HIV are among the most important infectious diseases in
sub-Saharan Africa. Approximately two-thirds of the estimated 35 million HIV infected persons
live in sub-Saharan Africa. Of the 300-500 million annual cases of malaria infection
occurring worldwide, about 90% of P. falciparum infections occur in sub-Saharan Africa,
resulting in approximately 1 million deaths, mostly in children under five years of age. It
is clear that HIV and malaria are responsible for substantial disease, suffering, and an
enormous economic burden on the people who can least afford it. Although a study in 1993 in
Tanzania showed significantly higher prevalence of malaria infections in HIV-positive
compared to HIV negative adults, until recently there have been few studies showing any
association between the two infections.
We conducted a study to measure the efficacy of the then-first line antimalarial drug
(sulfadoxine-pyrimethamine) among patients in three study arms: those who were HIV negative,
those who were HIV infected with CD4 cell counts < 200, and among HIV infected patients with
CD4 cell counts >= 200. Our hypothesis is that patients with HIV infection and low CD4 cell
count will not respond to antimalarial therapy as well as patients who are HIV infected with
higher CD4 cell counts or who are HIV negative.
Phase:
Phase 4
Details
Lead Sponsor:
Centers for Disease Control and Prevention
Collaborator:
Kenya Medical Research Institute
Treatments:
Antimalarials Fanasil, pyrimethamine drug combination Pyrimethamine Sulfadoxine