Clinical Trial: D4T or Abacavir Plus Vitamin Enhancement in HIV-Infected Patients (DAVE)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized, Open-Label Study of Continued Stavudine Versus Abacavir Substitution With or Without Riboflavin and Thiamine Supplementation in HIV-Infected Patients Who Have Elevated Venous Lactic Acid W

Brief Summary:

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.


Detailed Summary:
Sponsor: University of British Columbia

Current Primary Outcome: 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 ]

Original Primary Outcome:

  • 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.


Current Secondary Outcome:

  • Rate of decline of RVLA levels [ Time Frame: Unspecified ]
  • Absolute level of change of RVLA levels using baseline values as a covariant [ Time Frame: Unspecified ]
  • Proportion of patients improving/normalizing exercise testing mitochondrial dysfunction pattern [ Time Frame: Unspecified ]
  • Time to event: time to normalize venous lactic acid [ Time Frame: Unspecified ]
  • Time to event: premature therapy discontinuation, viral load rebound, and progression to a new AIDS defining illness or death [ Time Frame: Unspecified ]
  • 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 [ Time Frame: Unspecified ]
  • Absolute CD4/CD8 counts [ Time Frame: Unspecified ]
  • Incidence of grade III and greater adverse drug effects [ Time Frame: Unspecified ]
  • Metabolic laboratory assessments (anion gap, lipid and hepatic profile, and hematology) [ Time Frame: Unspecified ]


Original Secondary Outcome:

  • - Rate pf decline pf 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 or below to 50 copies/mL during the 16 week follow-up period on an intention to treat basis
  • - 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)


Information By: University of British Columbia

Dates:
Date Received: August 31, 2005
Date Started: August 2001
Date Completion:
Last Updated: September 24, 2008
Last Verified: September 2005