Vitamin B Therapy for Hyperlactatemia

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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. 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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Riboflavin; Thiamine; Vitamins

Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.