Tuberculosis Malaria
Conditions
Interventions
Tablets dihydroartemisinin-piperaquine (40mg/320mg)
Tablets artesunate-amodiaquine (100mg/270mg)
Sponsors
Infectious Diseases Institute, Makerer University College of Health Sciences
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tablets dihydroartemisinin-piperaquine group: Plasma concentrations of piperaquine during rifampicin treatment and after stopping rifampicin intake;Tablets dihydroartemisinin-piperaquine group: Plasma concentrations of dihydroartemisin during rifampicin treatment and after stopping rifampicin intake;Tablets artesunate-amodiaquine 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;Intravenous artesunate group: Plasma concentrations of artesunate and dihydroartemisinin during rifampicin intake and after stopping rifampicin intake | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of adverse events for each study drug during rifampicin intake and after stopping rifampicin intake | — |
Countries
Uganda
Contacts
Public ContactMichael Enyakoit
Regulatory Officer / Infectious Diseases Institute
Outcome results
None listed