Interactions Between Artemether-lumefantrine and Antiretrovirals in HIV-patients With Uncomplicated Malaria in Tanzania
Status:
Completed
Trial end date:
2013-01-01
Target enrollment:
Participant gender:
Summary
As HIV/AIDS is spreading in malaria-endemic countries, many patients here will need
concomitant treatment for both infections. Effective combination treatments are available for
both malaria (artemisinin-based combination treatments, ACTs) and HIV/AIDS (antiretroviral
combination treatments, ARTs), and these treatments are presently recommended for concomitant
use by ministries of health in many endemic countries, including Tanzania. However,
theoretically some of these drugs may be involved in harmful interactions with each other, as
they share common cytochrome enzymes involved in their metabolism. Such interactions could
lead to less effective treatments and/or adverse effects, as a consequence of reduced or
increased drug levels, respectively. Only little clinical and pharmacological information is
however yet available to guide clinicians and policy-makers on this issue.
The main aim of the InterACT study in Tanzania is to conduct a series of detailed
observational studies of clinical and paraclinical safety, therapeutic efficacy and
pharmacokinetic interactions between the currently nationally recommended first-line
treatment for malaria, artemether-lumefantrine, and first-line antiretroviral treatments,
primarily nevirapine-based combinations, for HIV/AIDS. The studies will be conducted among
patients with uncomplicated malaria, who attend the HIV/AIDS Care and Treatment Clinic and
Muheza Designated District Hospital in Muheza, north-eastern Tanzania, which is an area
characterized by intense transmission of Plasmodium falciparum malaria and with a prevalence
of HIV around 8-10%. The study is expected to inform guidelines for the treatment of malaria
in patients with HIV/AIDS in Tanzania, and elsewhere.
Phase:
Phase 4
Details
Lead Sponsor:
University of Copenhagen
Collaborators:
London School of Hygiene and Tropical Medicine National Institute for Medical Research, Tanzania
Treatments:
Artemether Artemether-lumefantrine combination Artemether, Lumefantrine Drug Combination Artemisinins Lumefantrine