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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00885287 |
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Date of registration:
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20/04/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Interactions Between Artemether-lumefantrine and Antiretrovirals in HIV-patients With Uncomplicated Malaria in Tanzania
InterACT |
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Scientific title:
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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 |
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Date of first enrolment:
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July 2009 |
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Target sample size:
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830 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00885287 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Tanzania
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Contacts
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Name:
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Martha Lemnge, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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National Institute for Medical Research, Tanzania |
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Name:
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Lasse Vestergaard, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Copenhagen |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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 Criteria:
- 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).
Age minimum:
15 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Malaria, Falciparum
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HIV Infections
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Intervention(s)
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Drug: Artemether-lumefantrine (AL)
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Primary Outcome(s)
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Clinical and parasitological efficacy of artemether-lumefantrine; incidence and severity of treatment-related clinical and paraclinical adverse events; changes in pharmacokinetic profiles of artemether-lumefantrine.
[Time Frame: 42 days of post-treatment follow-up]
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Secondary Outcome(s)
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Changes in pharmacokinetic profiles of nevirapine-based and other used antiretrovirals;
[Time Frame: 42 days of post-treatment follow-up]
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Secondary ID(s)
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NIMR/HQ/R.8a/Vol.IX/794
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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