Status:
COMPLETED
D4T or Abacavir Plus Vitamin Enhancement in HIV-Infected Patients (DAVE)
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
GlaxoSmithKline
CIHR Canadian HIV Trials Network
Conditions:
Acidosis, Lactic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 thiami...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2006
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00143702
Start Date
August 1 2001
End Date
August 1 2006
Last Update
September 25 2008
Active Locations (2)
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1
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
2
Positive Care Clinic
Toronto, Ontario, Canada