Status:
COMPLETED
Comparison of Plasma Drug Levels of Triomune 40 With Those of the Originator Products
Lead Sponsor:
Makerere University
Collaborating Sponsors:
Department of Foreign Affairs, Ireland
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study aims to compare the steady state pharmacokinetics of stavudine, lamivudine, and nevirapine in HIV positive Ugandan patients taking Triomune 40 with the pharmacokinetics of the originator pr...
Detailed Description
The introduction of combination antiretroviral therapy (ART) has revolutionised the treatment of HIV/AIDS. ART has been associated with significant reductions in morbidity and mortality mainly in weal...
Eligibility Criteria
Inclusion
- Age over eighteen years Ability to provide full informed written consent Confirmed diagnosis of HIV infection On ARV therapy with Triomune 40
Exclusion
- Haemoglobin \< 8g/dl Liver and renal function tests \> 3 times the upper limit of normal Pregnancy Use of know inhibitors or inducers of cytochrome P450 or P-glycoprotein. Use of herbal medications Weight \<60kg Intercurrent illness
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
End Date :
November 1 2007
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00455585
Start Date
January 1 2007
End Date
November 1 2007
Last Update
February 8 2008
Active Locations (1)
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1
Makerere University, Infectious Diseases Insititute
Kampala, Uganda, 22418