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

Primary Purpose

HIV Infections

Status
Suspended
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Lamivudine
Sponsored by
University of British Columbia
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV, Treatment Experienced

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Downtown IDC
  • Cool Aid Community Health Centre
  • St. Boniface General Hospital
  • McMaster University
  • Haven Program
  • Maple Leaf Clinic
  • Sunnybrook Hospital
  • Montreal General Hospital
  • Centre Hospitalier de l'université de Laval

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percent and absolute change in viral load from baseline to week 24 and week 48.
Change in CD4 count in both absolute number and percentage from baseline to week 24 and week 48.

Full Information

First Posted
August 31, 2005
Last Updated
September 24, 2008
Sponsor
University of British Columbia
Collaborators
CIHR Canadian HIV Trials Network
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1. Study Identification

Unique Protocol Identification Number
NCT00143728
Brief Title
3TC or No 3TC for HIV With 3TC Resistance
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Suspended
Why Stopped
Enrollment.
Study Start Date
January 2004 (undefined)
Primary Completion Date
May 2010 (Anticipated)
Study Completion Date
May 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of British Columbia
Collaborators
CIHR Canadian HIV Trials Network

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, Treatment Experienced

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
152 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Lamivudine
Intervention Description
See Detailed Description.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Percent and absolute change in viral load from baseline to week 24 and week 48.
Time Frame
48 weeks
Title
Change in CD4 count in both absolute number and percentage from baseline to week 24 and week 48.
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julio Montaner, MD
Organizational Affiliation
University of British Columbia/Providence Health Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
Downtown IDC
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Cool Aid Community Health Centre
City
Victoria
State/Province
British Columbia
Country
Canada
Facility Name
St. Boniface General Hospital
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Haven Program
City
Sudbury
State/Province
Ontario
Country
Canada
Facility Name
Maple Leaf Clinic
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Sunnybrook Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Montreal General Hospital
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Centre Hospitalier de l'université de Laval
City
Ste-Foy
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

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

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