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Home > "E" Clinical Trials Conditions > Effects of Storage on Lactate in Blood Samples  Effects of Storage on Lactate in Blood Samples
Effects of Storage on Lactate in Blood Samples
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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.
Total Enrollment: 13
Location and Contact Information:
Overall Study Official:
MichaelDube, Study Chair,
Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis, Indiana, 46202
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
UCSF - San Francisco Gen Hosp
San Francisco, California, 94110
United States
Additional Information:
Study ID Numbers: ACTG A5099; AACTG A5099
Study Start Date: January 2001
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00011050
Other Hiv Infections Studies:
1. Chemotherapy and Azidothymidine, With or Without Radiotherapy, for High Grade Lymphoma in AIDS-Risk Group Members
2. Safety and Effectiveness of Giving Adefovir Dipivoxil Plus Abacavir Plus Efavirenz Plus Amprenavir to HIV-Infected Patients Who Have Failed to Respond to Previous Protease Inhibitor Treatment
3. A Phase I Trial To Evaluate the Safety and Immunogenicity of the UBI HIV-1MN PND Peptide Immunogen, Given by IM Injection, in Combination With the UBI Microparticulate Monovalent HIV-1 MN Branched Peptide Given Orally, in HIV-1 Uninfected Volunteers.
4. Underlying abnormalities in fat and muscle leading to Lipodystrophy Syndrome
5. A Study of Nitazoxanide in the Treatment of AIDS-Related Diarrhea
Related Studies:
Other HIV Infections Clinical Trials
Other California Clinical Trials
Other San Francisco Clinical Trials
Effects of Storage on Lactate in Blood Samples
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