drugset / Trial / NCT00202228

Lactate Metabolism Study in HIV Infected Persons

NCT00202228

Non-randomizedParallel-groupOpen-labelHealth-services research

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.

Timeline

Start
2002-07
Primary completion
2008-10
Completion
2011-09

Drugs

EvaluationDrugModalityDoseRoute
Subject L-carnitine Other / unclassified 990 mg Oral
Subject Riboflavin Other / unclassified 100 mg Oral
Subject Thiamine Other / unclassified 50 mg Oral