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

This study has been completed.

Sponsor:

Collaborators:

GlaxoSmithKline

CIHR Canadian HIV Trials Network

Information provided by:

University of British Columbia

ClinicalTrials.gov Identifier:

NCT00143702

First received: August 31, 2005

Last updated: September 24, 2008

Last verified: September 2005

History of Changes

Tracking Information

First Received Date ^ICMJE

August 31, 2005

Last Updated Date

September 24, 2008

Start Date ^ICMJE

August 2001

Primary Completion Date

August 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

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.

Change History

Complete list of historical versions of study NCT00143702 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Rate of decline of RVLA levels [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
Absolute level of change of RVLA levels using baseline values as a covariant [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
Proportion of patients improving/normalizing exercise testing mitochondrial dysfunction pattern [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
Time to event: time to normalize venous lactic acid [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
Time to event: premature therapy discontinuation, viral load rebound, and progression to a new AIDS defining illness or death [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Change in absolute CD4 from baseline [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
Absolute CD4/CD8 counts [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
Incidence of grade III and greater adverse drug effects [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
Metabolic laboratory assessments (anion gap, lipid and hepatic profile, and hematology) [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

- Rate pf decline pf 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
- Proportion of patients with at least three consecutive HIV-1 RNA determinations equal or below to 50 copies/mL during the 16 week follow-up period on an intention to treat basis
- Change in absolute CD4 from baseline
- Absolute CD4/CD8 counts
- Incidence of grade III and greater adverse drug effects
- Metabolic laboratory assessments (anion gap, lipid and hepatic profile and hematology)

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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)

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Acidosis, Lactic

Intervention ^ICMJE

Drug: d4T
See Detailed Description.
Drug: Abacavir
See Detailed Description.
Drug: Riboflavin and Thiamine (Supplementation)
See Detailed Description.

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

August 2006

Primary Completion Date

August 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT00143702

Other Study ID Numbers ^ICMJE

P00-0159, CTN 169

Has Data Monitoring Committee

Not Provided

Responsible Party

Dr. Julio Montaner, University of British Columbia

Study Sponsor ^ICMJE

University of British Columbia

Collaborators ^ICMJE

GlaxoSmithKline
CIHR Canadian HIV Trials Network

Investigators ^ICMJE

Principal Investigator:

Julio Montaner, MD

University of British Columbia

Information Provided By

University of British Columbia

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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