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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00143702
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : September 25, 2008
Sponsor:
Collaborators:
Information provided by:

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.


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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : August 2001
Primary Completion Date : August 2006
Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Drug: d4T
    See Detailed Description.
    Drug: Abacavir
    See Detailed Description.
    Drug: Riboflavin and Thiamine (Supplementation)
    See Detailed Description.

Outcome Measures

Primary Outcome Measures :
  1. 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 Measures :
  1. Rate of decline of RVLA levels
  2. Absolute level of change of RVLA levels using baseline values as a covariant
  3. Proportion of patients improving/normalizing exercise testing mitochondrial dysfunction pattern
  4. Time to event: time to normalize venous lactic acid
  5. Time to event: premature therapy discontinuation, viral load rebound, and progression to a new AIDS defining illness or death
  6. 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 ]
  7. Change in absolute CD4 from baseline
  8. Absolute CD4/CD8 counts
  9. Incidence of grade III and greater adverse drug effects
  10. Metabolic laboratory assessments (anion gap, lipid and hepatic profile, and hematology)

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dr. Julio Montaner, University of British Columbia
ClinicalTrials.gov Identifier: NCT00143702     History of Changes
Other Study ID Numbers: P00-0159
CTN 169
First Posted: September 2, 2005    Key Record Dates
Last Update Posted: September 25, 2008
Last Verified: September 2005

Keywords provided by University of British Columbia:
Elevated Lactic Acid

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