Lactate Metabolism Study in HIV Infected Persons

NCT00202228 | Completed Phase 4

• 1 other identifier: DMED-629-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 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.

Conditions

HIV Infections; AIDS; Lactic Acidosis; Lipodystrophy

Keywords

HIV; HIV/AIDS; Lactic Acidosis; Supplementation; Lactate Clearance; Mitochondrial Toxicity; HAART

Outcome Measures

Primary Outcomes (1)

• Changes in lactate clearance pre and post supplementation

  two months

Secondary Outcomes (2)

• 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

• 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)

Study Arms (4)

1

EXPERIMENTAL

Individuals living with HIV who are naive to antiretroviral treatment, or who have been on a treatment interruption for at least six months

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

2

EXPERIMENTAL

Individuals living with HIV who are on an antiretroviral regimen including one of D4T/ddI/ddC/AZT

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

3

EXPERIMENTAL

Individuals living with HIV who are on an antiretroviral regimen including one of D4T/ddI/ddC/AZT and have liver disease.

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

4

EXPERIMENTAL

HIV negative control group

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

Interventions

cofactor supplementation (thiamine, riboflavin, L-carnitine) DRUG

Thiamine: 50 mg po od; Riboflavin: 100 mg po od; L-carnitine: 990 mg po bid.

Also known as: L-carnitine: Carnitor

1; 2; 3; 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Active AIDS defining illness
• Treatment with growth hormone
• Known poor adherence with therapy
• End stage renal disease
• Pregnancy

Sponsors & Collaborators

• Queen's University: lead
• Ontario HIV Treatment Network: collaborator

Study Sites (1)

Queen's University

Kingston, Ontario, K7L 3N6, Canada

Location

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome; Acidosis, Lactic; Lipodystrophy

Interventions

Thiamine; Riboflavin; Carnitine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Skin Diseases, Metabolic; Skin Diseases; Skin and Connective Tissue Diseases; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Flavins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Coenzymes; Enzymes and Coenzymes; Pigments, Biological; Biological Factors; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines

Study Officials

• Wendy Wobeser, MD

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: July 1, 2002
• Primary Completion: October 1, 2008
• Study Completion: September 1, 2011
• Last Updated: January 13, 2016

Record last verified: 2016-01

Locations

CA (1)