The purpose of this study is to determine the best way to treat people on d4T (stavudine) with high levels of lactic acid. Switching from d4T to abacavir will be assessed. Adding riboflavin and thiamine will also be assessed. Participants will be randomly assigned to one of four groups: * Group 1 participants will continue to take d4T as part of their antiretroviral (ARV) regimen, and will be given the vitamin supplements * Group 2 will continue to take d4T without vitamin supplements * Group 3 will switch from d4T to abacavir and receive the vitamins * Group 4 will switch from d4T to abacavir without vitamin supplements. The study plans to involve eighty participants from Canada and Argentina for a treatment period of 16 weeks and a follow-up visit at week 24.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
See Detailed Description.
See Detailed Description.
See Detailed Description.
St. Paul's Hospital
Vancouver, British Columbia, Canada
Positive Care Clinic
Toronto, Ontario, Canada
Proportion of patients per arm with random venous lactic acid (RVLA) below or equal to 2.1 mmol/L* at 16 weeks. (* Confirmed by a second determination 7-14 days later.)
Time frame: 16 weeks
Rate of decline of RVLA levels
Absolute level of change of RVLA levels using baseline values as a covariant
Proportion of patients improving/normalizing exercise testing mitochondrial dysfunction pattern
Time to event: time to normalize venous lactic acid
Time to event: premature therapy discontinuation, viral load rebound, and progression to a new AIDS defining illness or death
Proportion of patients with at least three consecutive HIV-1 RNA determinations equal to or below 50 copies/mL during the 16 week follow-up period on an intention to treat basis
Time frame: 16 weeks
Change in absolute CD4 from baseline
Absolute CD4/CD8 counts
Incidence of grade III and greater adverse drug effects
Metabolic laboratory assessments (anion gap, lipid and hepatic profile, and hematology)
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