Back to resultsD4T or Abacavir Plus Vitamin Enhancement in HIV-Infected Patients (DAVE)
Primary Purpose
Acidosis, Lactic
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
d4T
Abacavir
Riboflavin and Thiamine (Supplementation)
Sponsored by
About this trial
This is an interventional treatment trial for Acidosis, Lactic focused on measuring Elevated Lactic Acid
Eligibility Criteria
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
Sites / Locations
- St. Paul's Hospital
- Positive Care Clinic
Outcomes
Primary Outcome Measures
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.)
Secondary Outcome Measures
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
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)
Full Information
NCT ID
NCT00143702
First Posted
August 31, 2005
Last Updated
September 24, 2008
Sponsor
University of British Columbia
Collaborators
GlaxoSmithKline, CIHR Canadian HIV Trials Network
1. Study Identification
Unique Protocol Identification Number
NCT00143702
Brief Title
D4T or Abacavir Plus Vitamin Enhancement in HIV-Infected Patients (DAVE)
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 While on Stavudine-Based Therapy (DAVE)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
August 2001 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of British Columbia
Collaborators
GlaxoSmithKline, CIHR Canadian HIV Trials Network
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acidosis, Lactic
Keywords
Elevated Lactic Acid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
d4T
Intervention Description
See Detailed Description.
Intervention Type
Drug
Intervention Name(s)
Abacavir
Intervention Description
See Detailed Description.
Intervention Type
Drug
Intervention Name(s)
Riboflavin and Thiamine (Supplementation)
Intervention Description
See Detailed Description.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Rate of decline of RVLA levels
Title
Absolute level of change of RVLA levels using baseline values as a covariant
Title
Proportion of patients improving/normalizing exercise testing mitochondrial dysfunction pattern
Title
Time to event: time to normalize venous lactic acid
Title
Time to event: premature therapy discontinuation, viral load rebound, and progression to a new AIDS defining illness or death
Title
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
Title
Change in absolute CD4 from baseline
Title
Absolute CD4/CD8 counts
Title
Incidence of grade III and greater adverse drug effects
Title
Metabolic laboratory assessments (anion gap, lipid and hepatic profile, and hematology)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julio Montaner, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
Positive Care Clinic
City
Toronto
State/Province
Ontario
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
D4T or Abacavir Plus Vitamin Enhancement in HIV-Infected Patients (DAVE)
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