NCT00143702

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2001

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2001

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 2, 2005

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

September 25, 2008

Status Verified

September 1, 2005

Enrollment Period

5 years

First QC Date

August 31, 2005

Last Update Submit

September 24, 2008

Conditions

Acidosis, Lactic

Keywords

Elevated Lactic Acid

Outcome Measures

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.)

    16 weeks

Secondary Outcomes (10)

  • 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

  • +5 more secondary outcomes

Interventions

d4TDRUG

See Detailed Description.

AbacavirDRUG

See Detailed Description.

Riboflavin and Thiamine (Supplementation)DRUG

See Detailed Description.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Positive Care Clinic

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Acidosis, Lactic

Interventions

StavudineabacavirRiboflavinThiamineDietary Supplements

Condition Hierarchy (Ancestors)

AcidosisAcid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

ThymidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDideoxynucleosidesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesFlavinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-RingCoenzymesEnzymes and CoenzymesPigments, BiologicalBiological FactorsThiazolesSulfur CompoundsOrganic ChemicalsAzolesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Julio Montaner, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 31, 2005

First Posted

September 2, 2005

Study Start

August 1, 2001

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

September 25, 2008

Record last verified: 2005-09

Locations

CA(2)