Status:
COMPLETED
Drug Interaction Study Between Lumefantrine and Lopinavir/Ritonavir
Lead Sponsor:
Makerere University
Collaborating Sponsors:
University of Liverpool
Conditions:
HIV Infections
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
With the roll out of antiretroviral therapy (ARV) for HIV across sub-Saharan Africa an unprecedented number of people will be commencing lifelong therapy. Current estimates are that 5-6 million people...
Detailed Description
In 2004 there were an estimated 40 million people living with HIV, 95% of whom live in the developing world. It is estimated that 5-6 million of these require antiretroviral therapy (ARV) now, and thi...
Eligibility Criteria
Inclusion
- Age over eighteen
- Ability to provide full informed written consent
- Confirmed diagnosis of HIV infection
Exclusion
- Haemoglobin \< 8 g/dl
- HIV RNA (Viral Load) \> 400 c/ml (if on antiretroviral therapy)
- Malaria Parasitaemia
- 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
- QTc (Rate adjusted QT interval) \> 450 ms (men) or \> 470 ms (women)
- Intercurrent illness including malaria
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2008
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00619944
Start Date
February 1 2008
End Date
December 1 2008
Last Update
December 6 2010
Active Locations (1)
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1
Infectious Diseases Institute, Faculty of Medicine, Makerere University
Kampala, Uganda, 22418