Lactate Metabolism Study in HIV Infected Persons

• Register: ClinicalTrials.gov
• Last refreshed on: 25 January 2016
• Main ID: NCT00202228
• Date of registration: 13/09/2005
• Prospective Registration: No
• Primary sponsor: Queen's University
• Public title: Lactate Metabolism Study in HIV Infected Persons
• Scientific title: Lactic Acid Metabolism in HIV-Infected Persons. Predicting Abnormalities in Lactate Production and Clearance Related to Treatment and Liver Disease and Measuring the Impact of Vitamin Supplementation.
• Date of first enrolment: July 2002
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00202228
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
• Phase: Phase 4

Countries of recruitment

Canada

Contacts

• Name: Wendy Wobeser, MD
• Affiliation: Queen's University

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

AIDS

Lactic Acidosis

HIV Infections

Lipodystrophy

Intervention(s)

Drug: cofactor supplementation (thiamine, riboflavin, L-carnitine)

Primary Outcome(s)

Changes in lactate clearance pre and post supplementation [Time Frame: two months]

Secondary Outcome(s)

Evidence of adverse response to supplements and/or antiretroviral medications [Time Frame: two months (increased where necessary to cover any individual's entire study period should it exceed two months)]

to estimate the change in lactate metabolism and mitochondrial function after a change in antiretroviral therapy to a non D4t/ddC/ddI/AZT regime [Time Frame: six months]

Secondary ID(s)

DMED-629-02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ontario HIV Treatment Network