Pharmacokinetic study: interactions b/w Artemisinin-based Combination and Antiretroviral therapies in Malawi Phase I Step 2

• Register: PACTR
• Last refreshed on: 29 April 2013
• Main ID: PACTR2010030001971409
• Date of registration: 08/03/2010
• Primary sponsor: Liverpool School of Tropical Medicine
• Public title: Pharmacokinetic study: interactions b/w Artemisinin-based Combination and Antiretroviral therapies in Malawi Phase I Step 2
• Scientific title: Special populations and label explansion studies with the fixed does combinations artemether-lumefantrine, amodiaquine-artesunate, and dihydroartemisinin-piperaquine in Zambia, Malawi and Mozambique
• Date of first enrolment: 2012-01-02
• Target sample size: 162
• Recruitment status: Closed to recruitment: follow up complete
• URL: HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR2010030001971409
• Study type: interventional
• Study design: Parallel: different groups receive different interventions at same time during study,; Non-randomised,

Countries of recruitment

South Africa

Contacts

• Name: Victor Mwapasa
• Affiliation: Associate Professor/Malawi-Liverpool Wellcome Clinical Research Programme

• Name: Dianne Terlouw

Key inclusion & exclusion criteria

Inclusion criteria: 1. Residence of Blantyre City and the neighbouring districts.
2. Confirmed HIV positive clients
a. ART na?ve: with CD4 Cell count ?350 cells/mm3
b. ART-treated: with CD4 cell count ?250 cells/mm3 and receiving first-line, alternative first line or second line ART, as described in the background section, for ?6 months.
3. Age ?18 years
4. Ability to read and write and provide informed consent
5. Body weight at least 40kgs (so that they are eligible to receive recommended adult doses of the antimalarial drug)
6. Stated willingness to be contacted by phone or at home.
7. Stated willingness to be admitted in the hospital for 3 days and to remain within the vicinity of Blantyre city for 2 months after enrolment.
Exclusion criteria: 1. Body Mass Index less than 18.5kg/m2
2. CD4 Cell count `350 cells/mm3 among antiretroviral na?ve subjects and CD4 Cell count `250 cells/mm3 among ART-treated subjects.
3. Hemoglobin `8.5 g/dL
4. Receiving any antimalarial drugs within the past 4 weeks.
5. Receiving other drugs which are known inhibitors or inducers of P450 enzymes of P-glycoprotein (except cotrimoxazole prophylaxis, which is the standard of care in HIV-infected people).
6. History of regular intake of alcohol (btwice/week), tobacco (b3 times/week) or any use of illicit drugs
7. History or evidence of pre-existing diseases of the liver and kidneys ie if the serum transaminases levels are b3 times the upper limit of normal or urea and creatinine levels b1.5 times the upper limit of normal.
8. History or evidence of heart disease, including conductive abnormalities on electrocardiographs (ECGs) ie QTc intervalb450ms (men) and b470ms (females)
9. Clinical and/or laboratory evidence of other infections in addition to HIV, such as clinical malaria or microscopic asexual forms of Pf malaria, hepatitis B, pneumonia, tuberculosis, bacteremia etc.
10. Laboratory evidence of potentially life threatening white blood cell disorders such as neutropenia (absolute neutrophil count ` 0.500*109), lymphopenia (absolute lymphocyte count `0.35*109) and thrombocytopenia (absolute platelet count `25*109).
11. Physically unfit with Karnofsky score of `80%.
12. Hypersensitivity to any of the ACTs.
13. Pregnancy ie confirmed by a Human Chorionic Gonadotrophin test.
14. Current participation in any other therapeutic or vaccine trial


Age minimum: 18 Year
Age maximum: 60 Year
Gender: Both

Health Condition(s) or Problem(s) studied

HIV/AIDS
Malaria
null

Primary Outcome(s)

adverse events

Area under the curve (AUC) for the ACT

Source(s) of Monetary Support

EDCTP