Status:
COMPLETED
Lactate Metabolism Study in HIV Infected Persons
Lead Sponsor:
Queen's University
Collaborating Sponsors:
Ontario HIV Treatment Network
Conditions:
HIV Infections
AIDS
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 consequenc...
Detailed Description
The management of chronic HIV infection is increasingly dependent upon the management of long term toxicities of therapy. Toxicities are often metabolic and include hyperlipidemia, hyperglycemia, oste...
Eligibility Criteria
Inclusion
- 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
- Active AIDS defining illness
- Treatment with growth hormone
- Known poor adherence with therapy
- End stage renal disease
- Pregnancy
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00202228
Start Date
July 1 2002
End Date
September 1 2011
Last Update
January 13 2016
Active Locations (1)
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1
Queen's University
Kingston, Ontario, Canada, K7L 3N6