HIV InfectionsNCT00031057
Vitamin B Therapy for Hyperlactatemia
A study testing Thiamine hydrochloride and Riboflavin in people with 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 see if vitamin B can treat mild hyperlactatemia (a higher than normal level of lactate in the blood) in patients who take nucleoside reverse transcriptase inhibitors (NRTIs). Hyperlactatemia is a potentially life-threatening condition that can be associated with NRTI therapy. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Thiamine hydrochloride and Riboflavin
- How many people
- 225 participants
- Where
- 3 sitesUnited States
- Study dates
- Start not givento Mar 2003
- Phase
- Interventional
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients may be eligible for this study if they:
- Are at least 13 years old.
- Give written informed consent. Patients less than 18 years old must have written informed consent of a parent or guardian.
- Are HIV-infected.
- Have been using anti-HIV therapy containing an NRTI for at least 4 weeks before study entry and have no plan to change their anti-HIV treatment during the study.
- Fulfill at least 1 criterion listed in protocol indicating an elevated venous lactate measurement.
Who cannot join
- Patients may not be eligible for this study if they:
- Have inflammation of the pancreas 30 days before study entry.
- Have other medical conditions that may result in elevated lactate levels.
- Are pregnant or breast-feeding.
- Started experiencing certain symptoms within 30 days prior to study entry that might be due to hyperlactatemia.
- Have used metformin within 30 days prior to study entry.
Show all 13Show fewer
- Have used high-dose vitamin supplements containing vitamin B1 (thiamine) and/or vitamin B2 (riboflavin) within 30 days prior to study entry.
- Have used certain dietary supplements within 30 days prior to study entry.
- Use chemotherapy.
- Are receiving any unknown therapies or medications.
- Are allergic or sensitive to the study drug.
- Had an illness within 30 days before study entry that, in the opinion of the investigator, would interfere with the study.
- Use drugs or alcohol that, in the opinion of the investigator, would interfere with the study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
Case Western Reserve Univ
Cleveland, Ohio, 44106
Beth Israel Med Ctr
New York, New York, 10003
About this study
Official title: A Pilot Study of Oral B Vitamin Therapy for Asymptomatic or Mildly Symptomatic Hyperlactatemia in Patients on NRTIs
The purpose of this study is to see if vitamin B can treat mild hyperlactatemia (a higher than normal level of lactate in the blood) in patients who take nucleoside reverse transcriptase inhibitors (NRTIs).
Hyperlactatemia is a potentially life-threatening condition that can be associated with NRTI therapy. A lack of vitamin B may be related to the development of hyperlactatemia. However, no studies have been done to evaluate this. This study proposes that high doses of vitamin B may bring elevated lactate levels back to normal among patients taking NRTIs.
Read the detailed description
Hyperlactatemia, with or without lactic acidosis, is a potentially life-threatening condition that appears to be associated with NRTI therapy. The natural history of lactate elevation as a complication of NRTI therapy is not clearly understood; however, some patients receiving these therapies experience a progressive increase in lactate to symptomatic levels. Deficiencies in thiamine (vitamin B1) and riboflavin (vitamin B2) have been implicated as cofactors in producing hyperlactatemia and lactic acidosis in NRTI-treated patients. A nontoxic intervention that could prevent or reverse advancing lactic acidosis and preserve NRTI use would be highly desirable. To date, no controlled studies have been done to examine the potential role of dietary intake, B vitamin deficiency, and B vitamin therapy on the pathogenesis and clinical course on NRTI-associated lactic acidosis. The hypothesis proposed is that high-dose vitamin B treatment can normalize elevated lactate levels among NRTI-exposed individuals with moderately elevated lactate levels.
This study consists of 2 steps: Step 1 (screening) and Step 2 (treatment). Patients are screened during Step 1 for sustained hyperlactatemia and Step 2 eligibility. Patients with sustained hyperlactatemia but no symptoms that indicate high risk of progression to lactic acidosis and with no plans to change existing NRTI-containing antiretroviral therapy may enter Step 2. A fasting, nonexercise, venous lactate level is obtained at Step 2 entry for use as a baseline measurement, and every patient receives high-dose oral vitamin B1 and B2 therapy for 4 weeks. Fasting, nonexercise, venous lactate levels are measured at Weeks 1, 2, and 4 to observe the kinetics of changes in lactate levels on study treatment.
- Conditions
- HIV Infections
- Being tested
- Thiamine hydrochloride, Riboflavin
- Keywords
- Administration, Oral, Blood, Reverse Transcriptase Inhibitors, Riboflavin, Thiamine, Vitamin B Complex, Lactic Acid
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thiamine hydrochlorideDrug
RiboflavinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2002 (estimated)
- Primary completionMar 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Enrolment
- 225 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Christopher Pilcher, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00031057
- Sponsor's protocol ID
- ACTG A5129
- Other IDs
- AACTG A5129
- Status last verified
- Nov 2004
- First submitted
- 20 Feb 2002
- Last updated
- 28 Feb 2011
- Results posted
- No
Publications
Wohl DA, Pilcher CD, Evans S, Revuelta M, McComsey G, Yang Y, Zackin R, Alston B, Welch S, Basar M, Kashuba A, Kondo P, Martinez A, Giardini J, Quinn J, Littles M, Wingfield H, Koletar SL; Adult AIDS Clinical Trials Group A5129 Team. Absence of sustained hyperlactatemia in HIV-infected patients with risk factors for mitochondrial toxicity. J Acquir Immune Defic Syndr. 2004 Mar 1;35(3):274-8. doi: 10.1097/00126334-200403010-00008.
PubMed 15076242
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Oral B Vitamin Therapy for Asymptomatic or Mildly Symptomatic Hyperlactatemia in Patients on NRTIs
- ClinicalTrials.gov ID
- NCT00031057
- Acronym / sponsor ID
- ACTG A5129
- Conditions
- HIV Infections
- Keywords
- Administration, Oral, Blood, Reverse Transcriptase Inhibitors, Riboflavin, Thiamine, Vitamin B Complex, Lactic Acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Primary completion
- Mar 2003 (actual)
- First posted
- 22 Feb 2002 (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 see if vitamin B can treat mild hyperlactatemia (a higher than normal level of lactate in the blood) in patients who take nucleoside reverse transcriptase inhibitors (NRTIs).
Hyperlactatemia is a potentially life-threatening condition that can be associated with NRTI therapy. A lack of vitamin B may be related to the development of hyperlactatemia. However, no studies have been done to evaluate this. This study proposes that high doses of vitamin B may bring elevated lactate levels back to normal among patients taking NRTIs.
Detailed description
Hyperlactatemia, with or without lactic acidosis, is a potentially life-threatening condition that appears to be associated with NRTI therapy. The natural history of lactate elevation as a complication of NRTI therapy is not clearly understood; however, some patients receiving these therapies experience a progressive increase in lactate to symptomatic levels. Deficiencies in thiamine (vitamin B1) and riboflavin (vitamin B2) have been implicated as cofactors in producing hyperlactatemia and lactic acidosis in NRTI-treated patients. A nontoxic intervention that could prevent or reverse advancing lactic acidosis and preserve NRTI use would be highly desirable. To date, no controlled studies have been done to examine the potential role of dietary intake, B vitamin deficiency, and B vitamin therapy on the pathogenesis and clinical course on NRTI-associated lactic acidosis. The hypothesis proposed is that high-dose vitamin B treatment can normalize elevated lactate levels among NRTI-exposed individuals with moderately elevated lactate levels.
This study consists of 2 steps: Step 1 (screening) and Step 2 (treatment). Patients are screened during Step 1 for sustained hyperlactatemia and Step 2 eligibility. Patients with sustained hyperlactatemia but no symptoms that indicate high risk of progression to lactic acidosis and with no plans to change existing NRTI-containing antiretroviral therapy may enter Step 2. A fasting, nonexercise, venous lactate level is obtained at Step 2 entry for use as a baseline measurement, and every patient receives high-dose oral vitamin B1 and B2 therapy for 4 weeks. Fasting, nonexercise, venous lactate levels are measured at Weeks 1, 2, and 4 to observe the kinetics of changes in lactate levels on study treatment.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Are at least 13 years old.
- Give written informed consent. Patients less than 18 years old must have written informed consent of a parent or guardian.
- Are HIV-infected.
- Have been using anti-HIV therapy containing an NRTI for at least 4 weeks before study entry and have no plan to change their anti-HIV treatment during the study.
- Fulfill at least 1 criterion listed in protocol indicating an elevated venous lactate measurement.
Key exclusion criteria (13 listed)
- Have inflammation of the pancreas 30 days before study entry.
- Have other medical conditions that may result in elevated lactate levels.
- Are pregnant or breast-feeding.
- Started experiencing certain symptoms within 30 days prior to study entry that might be due to hyperlactatemia.
- Have used metformin within 30 days prior to study entry.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thiamine hydrochloride | Drug | – |
| Riboflavin | Drug | – |
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 28 Feb 2011.
- Results publication: PubMed 15076242Wohl DA, Pilcher CD, Evans S, Revuelta M, McComsey G, Yang Y, Zackin R, Alston B, Welch S, Basar M, Kashuba A, Kondo P, Martinez A, Giardini J, Quinn J, Littles M, Wingfield H, Koletar SL; Adult AIDS Clinical Trials Group A5129 Team. Absence of sustained hyperlactatemia in HIV-infected patients with risk factors for mitochondrial toxicity. J Acquir Immune Defic Syndr. 2004 Mar 1;35(3):274-8. doi: 10.1097/00126334-200403010-00008.
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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.
Christopher Pilcher study chair
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thiamine hydrochloride and Riboflavin in people with 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 6 inclusion and 13 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 28 Feb 2011. 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?
On the ClinicalTrials.gov record for NCT00031057, which also lists 1 linked publication.
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 28 Feb 2011.