A Study to See if Certain Antioxidants and Vitamins Will Keep Lactate Levels Down in Patients Taking Anti-HIV Drugs

Withdrawn before enrolling · Not applicable

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00037063

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

0

Last updated by the study team

2015-06-04

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.
• 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.

You may not qualify if…

• 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 vitamin C, E, B1, and/or B2.
• Use systemic cytotoxic chemotherapy.
• Actively use or are dependent on alcohol or drugs in a way that would affect the protocol.
• Had a short but intense illness within 30 days before entry that would interfere with participation in the study.
• Require or are unwilling to discontinue certain drugs.
• Have any condition that would affect their ability to participate in the study.
• Are taking vitamin supplements that include more that 200 percent of the Recommended Daily Allowance (RDA) of any of the study drugs and are unwilling to stop taking the supplements or substitute them with supplements that contain 200 percent or less than the RDA of the study drugs.

Where it is running

• Univ of Colorado Health Sciences Ctr — Denver, Colorado, United States
• Case Western Reserve Univ — Cleveland, Ohio, United States
• MetroHealth Med Ctr — Cleveland, Ohio, United States
• Univ of Pennsylvania, Philadelphia — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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