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NCT Number: NCT00885287

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

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Key information

Conditions

Malaria, Falciparum Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Malaria Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Vector Borne Diseases Virus Diseases

Age range

15 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Muheza Designated District Hospital

Muheza, Tanga, Tanzania

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Artemether-lumefantrine (AL)

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Changes in pharmacokinetic profiles of nevirapine-based and other used antiretrovirals;

    Time frame: 42 days of post-treatment follow-up

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • London School of Hygiene and Tropical Medicine
  • National Institute for Medical Research, Tanzania

Registry information

Official study 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

Acronym: InterACT

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Apr 21, 2009
Registry last updated
Jan 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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