3TC or No 3TC for HIV With 3TC Resistance

September 24, 2008 updated by: University of British Columbia

A Randomized Study to Evaluate Virologic Response Following Discontinuation vs. no Discontinuation of 3TC in Patients Who Are Infected With HIV With Previously Documented Reduced Susceptibility to 3TC and Who Have Adequate Virologic Suppression on Combination Antiretroviral Therapy

The purpose of this study is to compare the effects of continuing or discontinuing 3TC treatment in the presence of HIV virus with 3TC resistance for persons who are on a regimen including least three other anti-HIV drugs. The overall aim is to determine whether continuing 3TC is of benefit in HIV-positive persons who have already shown resistance to this drug.

Study Overview

Status

Suspended

Conditions

HIV Infections

Intervention / Treatment

Drug: Lamivudine

Study Type

Interventional

Enrollment (Anticipated)

152

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- British Columbia
  - Vancouver, British Columbia, Canada
    - Downtown IDC
  - Victoria, British Columbia, Canada
    - Cool Aid Community Health Centre
- Manitoba
  - Winnipeg, Manitoba, Canada
    - St. Boniface General Hospital
- Ontario
  - Hamilton, Ontario, Canada
    - McMaster University
  - Sudbury, Ontario, Canada
    - Haven Program
  - Toronto, Ontario, Canada
    - Sunnybrook Hospital
  - Toronto, Ontario, Canada
    - Maple Leaf Clinic
- Quebec
  - Montreal, Quebec, Canada
    - Montreal General Hospital
  - Ste-Foy, Quebec, Canada
    - Centre Hospitalier de l'Universite de Laval

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Be HIV positive
Be at least 18 years old.
Currently receiving 3TC for HIV infection in conjunction with at least three other antiretroviral drugs. Must have started this regimen at least three months prior to starting this study.
A plasma viral load of less than 50 copies/mL on at least two occasions (measured at least 28 days apart immediately prior to screening).
Evidence of resistance to 3TC

Exclusion Criteria:

Pregnancy or breastfeeding.
Hepatitis B surface antigen (HbsAg) positive at time of screening or with the previous year.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Virologic failure (VL above 50 copies/ml) on two consecutive dates, at least two weeks apart, in the absence of concurrent acute illness or recent immunization during the first 24 weeks. Time Frame: 24 weeks	24 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Percent and absolute change in viral load from baseline to week 24 and week 48. Time Frame: 48 weeks	48 weeks
Change in CD4 count in both absolute number and percentage from baseline to week 24 and week 48. Time Frame: 48 weeks	48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Collaborators

CIHR Canadian HIV Trials Network

Investigators

Principal Investigator: Julio Montaner, MD, University of British Columbia/Providence Health Care

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (Anticipated)

May 1, 2010

Study Completion (Anticipated)