Interactions Between Artemether-lumefantrine and Antiretrovirals in HIV-patients With Uncomplicated Malaria in Tanzania (InterACT)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Malaria, Falciparum HIV Infections |
Drug: Artemether-lumefantrine (AL) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- 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 ] [ Designated as safety issue: Yes ]
- Changes in pharmacokinetic profiles of nevirapine-based and other used antiretrovirals; [ Time Frame: 42 days of post-treatment follow-up ] [ Designated as safety issue: Yes ]
| Enrollment: | 830 |
| Study Start Date: | July 2009 |
| Study Completion Date: | January 2013 |
| Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 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
|
Drug: Artemether-lumefantrine (AL)
Standard treatment-dose of artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria according to national treatment guidelines
|
|
Active Comparator: HIV-positives receiving AL for malaria
HIV-positive patients not receiving antiretrovirals but receiving artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria
|
Drug: Artemether-lumefantrine (AL)
Standard treatment-dose of artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria according to national treatment guidelines
|
|
Active Comparator: HIV-negatives receiving AL for malaria
HIV-negative patients receiving artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria
|
Drug: Artemether-lumefantrine (AL)
Standard treatment-dose of artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria according to national treatment guidelines
|
Eligibility| Ages Eligible for Study: | 15 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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).
Contacts and Locations| Tanzania | |
| Muheza Designated District Hospital | |
| Muheza, Tanga Region, Tanzania | |
| Principal Investigator: | Lasse Vestergaard, MD, PhD | University of Copenhagen |
| Principal Investigator: | Martha Lemnge, PhD | National Institute for Medical Research, Tanzania |
More Information
Additional Information:
No publications provided
| Responsible Party: | Lasse Vestergaard, Dr, University of Copenhagen |
| ClinicalTrials.gov Identifier: | NCT00885287 History of Changes |
| Other Study ID Numbers: | NIMR/HQ/R.8a/Vol.IX/794 |
| Study First Received: | April 20, 2009 |
| Last Updated: | January 15, 2013 |
| Health Authority: | Tanzania: National Institute for Medical Research |
Keywords provided by University of Copenhagen:
|
uncomplicated malaria HIV/AIDS drug interactions antimalarial drug efficacy |
antiretrovirals pharmacovigilance Tanzania |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Malaria Malaria, Falciparum Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Protozoan Infections Parasitic Diseases |
Artemether Artemisinins Lumefantrine Artemether-lumefantrine combination Antifungal Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimalarials Antiprotozoal Agents Antiparasitic Agents Coccidiostats Schistosomicides Antiplatyhelmintic Agents Anthelmintics |
ClinicalTrials.gov processed this record on May 22, 2013