HIV InfectionsNCT00011050
Effects of Storage on Lactate in Blood Samples
An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- How many people
- 13 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2001to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants may be eligible for this study if they:
- Are at least 18 years old.
- Have sufficient forearm veins.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis, Indiana, 46202
UCSF - San Francisco Gen Hosp
San Francisco, California, 94110
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- HIV Infections
- Keywords
- Specimen Handling, Blood, Cryopreservation, Lactic Acid, Sodium Fluoride, Oxalates
- Medical subject headings
- HIV Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study startJan 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 13 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Michael Dube, Study chairKathleen Mulligan, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00011050
- Sponsor's protocol ID
- ACTG A5099
- Other IDs
- AACTG A5099
- Status last verified
- Nov 2004
- First submitted
- 9 Feb 2001
- Last updated
- 30 Jul 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Storage on Plasma Lactate Determinations
- ClinicalTrials.gov ID
- NCT00011050
- Acronym / sponsor ID
- ACTG A5099
- Conditions
- HIV Infections
- Keywords
- Specimen Handling, Blood, Cryopreservation, Lactic Acid, Sodium Fluoride, Oxalates
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Jan 2001
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Are at least 18 years old.
- Have sufficient forearm veins.
Key exclusion criteria (3 listed)
- Have a physical disability that prevents forearm exercise.
- Have any known medical reason, such as anemia, for not having 82 ml of blood drawn.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Dube study chair
Kathleen Mulligan study chair
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2008.