Status:
UNKNOWN
Drug Interaction Between Coartem® and Nevirapine, Efavirenz or Rifampicin in HIV Positive Ugandan Patients
Lead Sponsor:
Makerere University
Collaborating Sponsors:
Health Research Board, Ireland
Conditions:
HIV Infections
Tuberculosis
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
There are increasing numbers of HIV-infected patients in sub-Saharan Africa receiving antiretroviral drugs and/or rifampicin based antituberculous therapy. HIV infected patients are at an increased ri...
Detailed Description
Coartem® is the combination of artemether and lumefantrine used for the treatment of uncomplicated falciparum malaria 1. This oral combination seems to be well-tolerated and is useful for treatment of...
Eligibility Criteria
Inclusion
- Age over eighteen years
- Ability to provide full written informed consent
- Confirmed diagnosis of HIV infection
Exclusion
- Haemoglobin \< 8g/dl
- Liver and renal function tests \> 3 times the upper limit of normal
- Pregnancy
- Use of known inhibitors or inducers of cytochrome P450 or P-glycoprotein.
- Use of herbal medications (information will be obtained from patients' medication history through interview with the patient)
- Abnormal EKG ie QTc (Rate adjusted QT interval) \>450ms (men) or \>470ms (women)
- Intercurrent Illness including malaria
- Known hypersensitivity to artemisinin-derivatives, halofantrine or lumefantrine
- History of cardiac disease
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2011
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00620438
Start Date
February 1 2008
End Date
July 1 2011
Last Update
December 6 2010
Active Locations (1)
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1
Infectious Diseases Institute, Makerere University
Kampala, Uganda, 22418