Vitamin B Therapy for Hyperlactatemia

Completed · Not applicable

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00031057

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

225

Last updated by the study team

2011-02-28

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• 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.

Where it is running

• Beth Israel Med Ctr — New York, New York, United States
• Univ of North Carolina — Chapel Hill, North Carolina, United States
• Case Western Reserve Univ — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.