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

NCT00143702 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2008-09-25

No results posted yet for this study

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.

Conditions

  • Acidosis, Lactic

Interventions

DRUG

d4T

See Detailed Description.

DRUG

Abacavir

See Detailed Description.

DRUG

Riboflavin and Thiamine (Supplementation)

See Detailed Description.

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • CIHR Canadian HIV Trials Network

    collaborator NETWORK

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Julio Montaner, MD · University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-08-31
Primary Completion
2006-08-31
Completion
2006-08-31

Countries

  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00143702 on ClinicalTrials.gov