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Effects of Storage on Lactate in Blood Samples

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00011050
First received: February 9, 2001
Last updated: July 29, 2008
Last verified: November 2004

February 9, 2001
July 29, 2008
January 2001
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Complete list of historical versions of study NCT00011050 on ClinicalTrials.gov Archive Site
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Effects of Storage on Lactate in Blood Samples
Effects of Storage on Plasma Lactate Determinations

The purpose of this study is to determine whether laboratory storage of samples affects the amount of lactate over 3 years.

Lactate is a natural substance normally present in the body. Lactate levels can go up for many different reasons, including treatment with nucleotide reverse transcriptase inhibitor drugs. This study will help researchers know if stored blood samples can be used to test lactate levels.

Lactic acidosis syndrome is a complication of therapy with nucleoside reverse transcriptase inhibitor (NRTI) drugs. Measurement of lactate levels is important in clinical trials of antiretroviral treatments. The preferred collection method for determining plasma lactate is with NaF/KOx tubes, while a number of ACTG studies have stored blood in ethylenediaminetetraacetic acid (EDTA) tubes. This study will analyze lactate in samples collected and stored in NaF/KOx and EDTA tubes to investigate the reliability of lactate concentrations over time.

Pre- and post-exercise blood samples are drawn from participants into NaF/KOx and EDTA tubes and a portion is tested for lactate levels immediately. The remaining portions are frozen and tested at 1, 3, 6, 12, 18, 24, and 36 months.

Observational
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HIV Infections
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
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Inclusion Criteria

Participants may be eligible for this study if they:

  • Are at least 18 years old.
  • Have sufficient forearm veins.

Exclusion Criteria

Participants will not be eligible for this study if they:

  • Have a physical disability that prevents forearm exercise.
  • Have any known medical reason, such as anemia, for not having 82 ml of blood drawn.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00011050
ACTG A5099, AACTG A5099
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National Institute of Allergy and Infectious Diseases (NIAID)
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Study Chair: Michael Dube
Study Chair: Kathleen Mulligan
National Institute of Allergy and Infectious Diseases (NIAID)
November 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP