A Study to See if Certain Antioxidants and Vitamins Will Keep Lactate Levels Down in Patients Taking Anti-HIV Drugs
HIV Infections
About this trial
This is an interventional prevention trial for HIV Infections focused on measuring Pilot Projects, Recurrence, Antioxidants, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Ascorbic Acid, Alpha-Tocopherol, Riboflavin, Thiamine, Lactic Acid
Eligibility Criteria
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 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.
Sites / Locations
- Univ of Colorado Health Sciences Ctr
- Case Western Reserve Univ
- MetroHealth Med Ctr
- Univ of Pennsylvania, Philadelphia