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

Acidosis, Lactic Clinical Trial

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)

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acidosis, Lactic

• NCT number: NCT00143702
• Study type: Interventional
• Source: University of British Columbia
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: August 2001
• Completion date: August 2006