HIV Infections Clinical Trial
Official title:
Study of Therapeutic Efficacy, Safety and Pharmacokinetic Interactions Between Artemether-lumefantrine and Nevirapine-based Antiretrovirals in HIV-infected Patients With Uncomplicated Falciparum-malaria in Muheza, Northeastern Tanzania
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.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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