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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00202228
Other study ID # DMED-629-02
Secondary ID
Status Completed
Phase Phase 4
First received September 13, 2005
Last updated January 12, 2016
Start date July 2002
Est. completion date September 2011

Study information

Verified date January 2016
Source Queen's University
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial Summary

Lactic acidosis is a potentially life-threatening disease associated with the treatment of chronic HIV infection. Although acidosis is rare, hyperlactatemia is common and may have long term consequences yet to be recognized. Lactic acidosis is a manifestation of mitochondrial toxicity; consequences which have yet to be fully recognized and understood. In this study, we propose to look at lactate clearance and production by two methods, in four treatment groups, including HIV positive subjects on highly active antiretroviral therapy (HAART) treatment regimes and without HAART regimes, with liver steatosis and without, and compared with HIV negative controls. Supplementation with cofactors thiamine, niacin and L-carnitine, which may have a positive effect on lactate metabolism by facilitating mitochondrial function, will be studied as well.


Description:

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Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Intervention

Drug:
cofactor supplementation (thiamine, riboflavin, L-carnitine)
Thiamine: 50 mg po od; Riboflavin: 100 mg po od; L-carnitine: 990 mg po bid.

Locations

Country Name City State
Canada Queen's University Kingston Ontario

Sponsors (2)

Lead Sponsor Collaborator
Queen's University Ontario HIV Treatment Network

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in lactate clearance pre and post supplementation two months No
Secondary to estimate the change in lactate metabolism and mitochondrial function after a change in antiretroviral therapy to a non D4t/ddC/ddI/AZT regime six months No
Secondary Evidence of adverse response to supplements and/or antiretroviral medications two months (increased where necessary to cover any individual's entire study period should it exceed two months) Yes
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