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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
  Purpose

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.


Condition Intervention Phase
Acidosis, Lactic
Drug: d4T
Drug: Abacavir
Drug: Riboflavin and Thiamine (Supplementation)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

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.) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 80
Study Start Date: August 2001
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: d4T
    See Detailed Description.
    Drug: Abacavir
    See Detailed Description.
    Drug: Riboflavin and Thiamine (Supplementation)
    See Detailed Description.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00143702

Locations
Canada, British Columbia
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Ontario
Positive Care Clinic
Toronto, Ontario, Canada
Sponsors and Collaborators
University of British Columbia
GlaxoSmithKline
CIHR Canadian HIV Trials Network
Investigators
Principal Investigator: Julio Montaner, MD University of British Columbia
  More Information

No publications provided

Responsible Party: Dr. Julio Montaner, University of British Columbia
ClinicalTrials.gov Identifier: NCT00143702     History of Changes
Other Study ID Numbers: P00-0159, CTN 169
Study First Received: August 31, 2005
Last Updated: September 24, 2008
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Elevated Lactic Acid

Additional relevant MeSH terms:
Acidosis, Lactic
Acid-Base Imbalance
Acidosis
Metabolic Diseases
Abacavir
Riboflavin
Thiamine
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Dermatologic Agents
Enzyme Inhibitors
Growth Substances
Micronutrients
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Photosensitizing Agents
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Reverse Transcriptase Inhibitors
Therapeutic Uses
Vitamin B Complex
Vitamins

ClinicalTrials.gov processed this record on November 25, 2014