skip to content

Clinical Trials

MainTitle

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

This study has been suspended
Sponsor
University of British Columbia

Collaborator
CIHR Canadian HIV Trials Network

Information provided by (Responsible Party)
University of British Columbia
ClinicalTrials.gov Identifier
NCT00143728

First received: August 31, 2005
Last updated: September 24, 2008
Last Verified: September 2008
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
HIV Infections

Drug : Lamivudine
Phase 4

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

Further study details as provided by University of British Columbia:

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

Estimated Enrollment: 152
Study Start Date: January 2004
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00143728

Locations

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

Sponsors and Collaborators

University of British Columbia
CIHR Canadian HIV Trials Network

Investigators

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

More Information


Responsible Party: Dr. Julio Montaner, University of British Columbia  
ClinicalTrials.gov Identifier: NCT00143728   History of Changes  
Other Study ID Numbers: P03-0051  
  CTN 189  
Study First Received: August 31, 2005  
Last Updated: September 24, 2008  

Keywords provided by University of British Columbia:

HIV
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Lamivudine

ClinicalTrials.gov processed this data on October 20, 2017
This information is provided by ClinicalTrials.gov.