Status:
COMPLETED
Interactions Between Artemether-lumefantrine and Antiretrovirals in HIV-patients With Uncomplicated Malaria in Tanzania
Lead Sponsor:
University of Copenhagen
Collaborating Sponsors:
National Institute for Medical Research, Tanzania
London School of Hygiene and Tropical Medicine
Conditions:
Malaria, Falciparum
HIV Infections
Eligibility:
All Genders
15-60 years
Phase:
PHASE4
Brief 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 (artemisi...
Eligibility Criteria
Inclusion
- HIV-positive and HIV-negative patients with confirmed P. falciparum infection in the presence of either measured fever (\> 37.5°C) or a history of fever within the previous 24 hours; for HIV-positive patients also afebrile patients are eligible in the presence of other symptoms of malaria (e.g., coughing, diarrhea, headache, nausea, body weakness, body pain).
- Not being pregnant or lactating.
- Absence of history of clinically significant hypersensitivity reactions to any of the study medicines being evaluated.
- For HIV-positive patients on cART, successful adherence to treatment without prominent adverse events for a period of a minimum of six weeks prior to the date of enrollment will be required.
- Easy access to the health facility (travel time \< 1 hour) and the ability to attend the stipulated follow-up visits.
- Informed consent provided by the patient or by a parent/guardian
Exclusion
- Patients below body weight of 10 kilograms (for under fives).
- Existence of underlying chronic severe illness (e.g., cardiac, renal or hepatic disease).
- No use within the previous four weeks prior to enrollment of any other antimalarial or other drug with antimalarial activity (with the exception of drugs required as part of standard treatment of HIV/AIDS, e.g., sulfamethoxazole and trimethoprim).
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
830 Patients enrolled
Trial Details
Trial ID
NCT00885287
Start Date
July 1 2009
End Date
January 1 2013
Last Update
January 16 2013
Active Locations (1)
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1
Muheza Designated District Hospital
Muheza, Tanga, Tanzania