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

This study has been completed.
Sponsor:
Collaborators:
GlaxoSmithKline
CIHR Canadian HIV Trials Network
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00143702
First received: August 31, 2005
Last updated: September 24, 2008
Last verified: September 2005

August 31, 2005
September 24, 2008
August 2001
August 2006   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
  • 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.
Complete list of historical versions of study NCT00143702 on ClinicalTrials.gov Archive Site
  • Rate of decline of RVLA levels [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
  • Absolute level of change of RVLA levels using baseline values as a covariant [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
  • Proportion of patients improving/normalizing exercise testing mitochondrial dysfunction pattern [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
  • Time to event: time to normalize venous lactic acid [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
  • Time to event: premature therapy discontinuation, viral load rebound, and progression to a new AIDS defining illness or death [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change in absolute CD4 from baseline [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
  • Absolute CD4/CD8 counts [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
  • Incidence of grade III and greater adverse drug effects [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
  • Metabolic laboratory assessments (anion gap, lipid and hepatic profile, and hematology) [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
  • - 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)
Not Provided
Not Provided
 
D4T or Abacavir Plus Vitamin Enhancement in HIV-Infected Patients (DAVE)
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 While on Stavudine-Based Therapy (DAVE)

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acidosis, Lactic
  • Drug: d4T
    See Detailed Description.
  • Drug: Abacavir
    See Detailed Description.
  • Drug: Riboflavin and Thiamine (Supplementation)
    See Detailed Description.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
August 2006
August 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Be HIV-positive
  • Be 18 years of age or older
  • Have a viral load equal to or below 50 copies/mL
  • Have been on a d4T-containing multiple drug regimen (at least three agents in total) for at least six months
  • Have been on a stable ARV regimen for the three months prior to enrollment
  • Have a venous lactic acid measurement above 2.1 mmol/L within the three months prior to enrollment and two consecutive measurements above 2.1 but lower than 6.0 within a two-week period of screening
  • Be willing to discontinue L-carnitine and/or coenzyme Q10
  • Be willing and able to provide informed consent

Exclusion Criteria:

  • Pregnancy or breastfeeding
  • Venous lactic acid equal to or above 6.0 mmol/L
  • Previous exposure to abacavir
  • Virologic rebound while on a previous regimen consisting of dual or triple nucleoside reverse transcriptase inhibitors (NRTIs)
  • Use of hydroxyurea within the three months prior to enrollment
  • Use of metformin
  • Any acute cardiopulmonary illness or infection
  • New AIDS-defining illness diagnosed within four weeks of enrollment
  • Riboflavin or thiamine supplementation above 20 mg/day within 30 days prior to enrollment
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00143702
P00-0159, CTN 169
Not Provided
Dr. Julio Montaner, University of British Columbia
University of British Columbia
  • GlaxoSmithKline
  • CIHR Canadian HIV Trials Network
Principal Investigator: Julio Montaner, MD University of British Columbia
University of British Columbia
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP