Lactate Metabolism Study in HIV Infected Persons

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Queen's University
• Collaborator: Ontario HIV Treatment Network
• Treatments: Riboflavin; Thiamine

Criteria

Inclusion Criteria:

• Participants at least 18 years of age or older either:

• HIV negative, or

• HIV positive, not on antiretroviral therapy (for at least 6 months) or

• HIV positive, on D4T/ddC/ddI/AZT containing HAART or

• HIV positive, on D4T/ddC/ddI/AZT containing HAART, with hepatic steatosis/liver disease

• No evidence of acute illness on physical or laboratory examination

• Patients who have voluntarily consented to the study and signed the appropriate consent

• have not been supplementing with multi-vitamins, thiamine, riboflavin for at least 2 months prior to inclusion

Exclusion Criteria:

• Active AIDS defining illness

• Treatment with growth hormone

• Known poor adherence with therapy

• End stage renal disease

• Pregnancy