NCT00037063 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Brinkman K, Kakuda TN
Mitochondrial toxicity of nucleoside analogue reverse transcriptase inhibitors: a looming obstacle for long-term antiretroviral therapy? Curr Opin Infect Dis. 2000 Feb;13(1):5-11.
Brinkman K, Smeitink JA, Romijn JA, Reiss P
Mitochondrial toxicity induced by nucleoside-analogue reverse-transcriptase inhibitors is a key factor in the pathogenesis of antiretroviral-therapy-related lipodystrophy. Lancet. 1999 Sep 25;354(9184):1112-5. Review.
Brinkman K, Vrouenraets S, Kauffmann R, Weigel H, Frissen J
Treatment of nucleoside reverse transcriptase inhibitor-induced lactic acidosis. AIDS. 2000 Dec 1;14(17):2801-2.

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

Details for clinical trial NCT00037063

Clinical trial NCT00037063 - References