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

University of British Columbia

Status and phase

Completed

Phase 3

Phase 2

Conditions

Acidosis, Lactic

Treatments

Drug: Riboflavin and Thiamine (Supplementation)

Drug: d4T

Drug: Abacavir

Study type

Interventional

Funder types

Other

NETWORK

Industry

Identifiers

NCT00143702

CTN 169

P00-0159

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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