A Study to See if Certain Antioxidants and Vitamins Will Keep Lactate Levels Down in Patients Tak… (NCT00037063) | Clinical Trial Compass
WithdrawnNot Applicable
A Study to See if Certain Antioxidants and Vitamins Will Keep Lactate Levels Down in Patients Taking Anti-HIV Drugs
United States0
Plain-language summary
The purpose of this study is to see if certain vitamins (C, E, B1, and B2) can keep lactate levels from becoming too high in patients who are taking nucleoside reverse transcriptase inhibitor (NRTI) anti-HIV drugs.
Some patients taking anti-HIV drugs develop hyperlactatemia. Hyperlactatemia is a condition in which lactate (a natural substance normally present in the body) levels are too high. Too much lactate in the body can lead to serious health problems. When patients suffer from hyperlactatemia while taking anti-HIV drugs, most doctors temporarily stop the drugs. Patients then restart the anti-HIV drugs when their lactate levels return to normal. If patients restart the same drugs they were taking when they developed hyperlactatemia, there is a risk that they may develop high lactate levels again. This study wants to find out if taking antioxidants (substances that reduce tissue damage due to oxygen radicals) and certain B vitamins may help prevent patients from developing hyperlactatemia when they restart the same anti-HIV drugs.
Who can participate
Age range
13 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
Patients may be eligible for this study if they:
* Are at least 13 years old.
* Are HIV infected.
* Agree not to become pregnant or to impregnate during the study. The study volunteer/partner must use acceptable methods of contraception while receiving the study drugs and for 1 month after stopping the study drugs. Men and women who cannot have children do not need to use contraception.
* Have had their first episode of serious hyperlactatemia (including lactic acidosis) within 180 days prior to study entry. Serious hyperlactatemia must have led to discontinuation of all anti-HIV drugs.
* Have limited anti-HIV drug choices because of prior intolerance to anti-HIV drugs or virologic failure.
* Are willing and able to restart the same anti-HIV regimen that led to the episode of serious hyperlactatemia.
* Have complete resolution or return to baseline of all the signs and symptoms thought to be related to the episode of hyperlactatemia.
Exclusion Criteria
Patients may not be eligible for this study if they:
* Were on an abacavir-containing regimen for less than 6 weeks at the time of the hyperlactatemia episode or had a fever or rash during the episode of hyperlactatemia, regardless of the length of time on abacavir.
* Are pregnant or breast-feeding.
* Have any medical condition or drug use that could have, by itself, resulted in hyperlactatemia.
* Were diagnosed with pancreatitis at the time of the hyperlactatemia episode.
* Are allergic/sensitive to vit…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Trial details
NCT IDNCT00037063
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)