Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2025-12-24 @ 6:56 PM
NCT ID:
NCT00031057
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Study:
NCT00031057
Study Brief:
Protocol Section:
NCT00031057