ARTEM-TB STUDY

• Register: PACTR
• Last refreshed on: 29 April 2013
• Main ID: PACTR201302000483287
• Date of registration: 14/01/2013
• Primary sponsor: Infectious Diseases Institute, Makerer University College of Health Sciences
• Public title: ARTEM-TB STUDY
• Scientific title: EVALUATING PHARMACOKINETIC INTERACTIONS BETWEEN ARTEMISININ-BASED THERAPIES AND RIFAMPICIN-BASED TUBERCULOSIS TREATMENT IN AFRICAN PATIENTS
• Date of first enrolment: 2013-01-31
• Target sample size: 36
• Recruitment status: Not yet recruiting
• URL: HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201302000483287
• 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: Michael Enyakoit
• Affiliation: Regulatory Officer / Infectious Diseases Institute

• Name: Mohammed Lamorde
• Affiliation: Research Fellow / Infectious Diseases Institute

Key inclusion & exclusion criteria

Inclusion criteria:
? Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.

? Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

? Aged between 18 to 65 years, inclusive.

? Receiving TB-therapy containing rifampicin for at least 2 weeks

Exclusion criteria: ? Hypersensitivity to any of the study drugs or excipients
? HIV infection
? Malaria infection at screening
? Serum hemoglobin ` 8g/dL
? Elevations in serum levels of alanine transaminase, aspartate transaminase or creatinine above 3 times the upper limit of normal
? History of cardiac disease
? Diarrhea lasting greater than one week
? Use of herbal medications
? Use of potent inhibitors of CYP3A4 including grapefruit juice within 1 week of first dose of study drug and for the duration of the study
? Pregnant or lactating females


Age minimum: 18 Year
Age maximum: 65 Year
Gender: Both

Health Condition(s) or Problem(s) studied

Tuberculosis
Malaria
null

Primary Outcome(s)

Intravenous artesunate group: Plasma concentrations of artesunate and dihydroartemisinin during rifampicin intake and after stopping rifampicin intake

Tablets artesunate-amodiaquine group: Plasma concentrations of amodiaquine and desethylamodiaquine during rifampicin intake and after stopping rifampicin intake

Tablets artesunate-amodiaquine group: Plasma concentrations of artesunate and dihydroartemisinin during rifampicin intake and after stopping rifampicin intake

Tablets dihydroartemisinin-piperaquine group: Plasma concentrations of dihydroartemisin during rifampicin treatment and after stopping rifampicin intake

Tablets dihydroartemisinin-piperaquine group: Plasma concentrations of piperaquine during rifampicin treatment and after stopping rifampicin intake

Secondary Outcome(s)

Frequency of adverse events for each study drug during rifampicin intake and after stopping rifampicin intake

Secondary ID(s)

HS1294

Source(s) of Monetary Support

European & Developing Countries Clinical Trials Partnership