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Completed

NCT Number: NCT00143702

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

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Key information

Conditions

Acidosis, Lactic Acid-Base Imbalance Acidosis Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

St. Paul's Hospital, Vancouver, British Columbia, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

d4T

Drug

See Detailed Description.

Abacavir

Drug

See Detailed Description.

Riboflavin and Thiamine (Supplementation)

Drug

See Detailed Description.

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • CIHR Canadian HIV Trials Network
  • GlaxoSmithKline

Registry information

Official study 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)

Important dates

Study start
2001
Primary completion
2006
Study completion
2006
First posted
Sep 2, 2005
Registry last updated
Sep 25, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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