A Pilot Study of the Efficacy of a Combination of Antioxidants and B Vitamins in Preventing the Recurrence of Hyperlactatemia in Subjects Who Have Limited Antiretroviral Options

Hyperlactatemia is a serious complication of NRTI treatment for HIV. Most physicians temporarily discontinue antiretroviral therapy in patients with serious hyperlactatemia, then restart antiretrovirals after lactate levels normalize. Two options for restarting antiretrovirals are to switch to different NRTIs or switch to an NRTI-sparing regimen. The latter option is probably safer, but a growing number of the HIV-infected population has already been exposed to all available classes of antiretrovirals and may lack this option. This study will investigate the ability of antioxidants and B vitamins to prevent the recurrence of hyperlactatemia in patients who restart the same NRTI-containing regimen.

Patients have 2 clinic visits (screening and pre-entry) prior to entry into the study. Prior to these visits, patients must fast and refrain from exercise for at least 8 hours. At the screening visit, blood is drawn for a lactate level. Women of reproductive potential have a pregnancy test. At the pre-entry visit, blood is drawn for a second lactate level.

Within 30 days of the screening visit, patients return to the clinic to enter the study. Patients should not eat or drink, except medications and water, for at least 8 hours prior to this visit. Upon study entry, the following are performed: a physical exam; blood draw for routine lab tests, HIV viral load, CD4 count, and repeat lactate; urinalysis; and a pregnancy test. All patients receive the following regimen through Week 48: vitamins C, E, B1, and B2. One week after starting the vitamin regimen, patients are restarted on the same antiretroviral regimen that they were receiving at the time of hyperlactatemia. Within 30 days of study entry, the patients should be on the exact same doses of antiretrovirals that they were receiving at the time of hyperlactatemia, taking into account any necessary dose escalations. Evaluations are performed at Weeks 2, 4, 6, and 8 and every 4 weeks thereafter until Week 24. After Week 24, evaluations are then performed at 8-week intervals through Week 48. Antiretrovirals are not supplied by the study.