Interactions Between Artemether-lumefantrine and Antiretrovirals in HIV-patients With Uncomplicated Malaria in Tanzania

NCT ID: NCT00885287

Last Updated: 2013-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 830 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2013-01-31

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 (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.

Conditions

Malaria, Falciparum; HIV Infections

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HIV-positives on ARVs receiving AL for malaria

HIV-positive patients on first-line ARVs receiving artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria

Group Type: ACTIVE_COMPARATOR

Artemether-lumefantrine (AL)

Intervention Type: DRUG

Standard treatment-dose of artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria according to national treatment guidelines

HIV-positives receiving AL for malaria

HIV-positive patients not receiving antiretrovirals but receiving artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria

Group Type: ACTIVE_COMPARATOR

Artemether-lumefantrine (AL)

Intervention Type: DRUG

Standard treatment-dose of artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria according to national treatment guidelines

HIV-negatives receiving AL for malaria

HIV-negative patients receiving artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria

Group Type: ACTIVE_COMPARATOR

Artemether-lumefantrine (AL)

Intervention Type: DRUG

Standard treatment-dose of artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria according to national treatment guidelines

Interventions

Artemether-lumefantrine (AL)

Standard treatment-dose of artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria according to national treatment guidelines

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute for Medical Research, Tanzania

OTHER_GOV

Sponsor Role: collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role: collaborator

University of Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Lasse Vestergaard

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lasse Vestergaard, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen

Martha Lemnge, PhD

Role: PRINCIPAL_INVESTIGATOR

National Institute for Medical Research, Tanzania

Locations

Muheza Designated District Hospital

Muheza, Tanga, Tanzania

Countries

Tanzania

Other Identifiers

NIMR/HQ/R.8a/Vol.IX/794

Identifier Type: -

Identifier Source: org_study_id