Study Stopped
Enrollment.
3TC or No 3TC for HIV With 3TC Resistance
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
2 other identifiers
interventional
152
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 hiv-infections
Started Jan 2004
Longer than P75 for phase_4 hiv-infections
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 31, 2005
CompletedFirst Posted
Study publicly available on registry
September 2, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedSeptember 25, 2008
September 1, 2008
6.3 years
August 31, 2005
September 24, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
24 weeks
Secondary Outcomes (2)
Percent and absolute change in viral load from baseline to week 24 and week 48.
48 weeks
Change in CD4 count in both absolute number and percentage from baseline to week 24 and week 48.
48 weeks
Interventions
See Detailed Description.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnancy or breastfeeding.
- Hepatitis B surface antigen (HbsAg) positive at time of screening or with the previous year.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of British Columbialead
- CIHR Canadian HIV Trials Networkcollaborator
Study Sites (9)
Downtown IDC
Vancouver, British Columbia, Canada
Cool Aid Community Health Centre
Victoria, British Columbia, Canada
St. Boniface General Hospital
Winnipeg, Manitoba, Canada
Haven Program
Greater Sudbury, Ontario, Canada
McMaster University
Hamilton, Ontario, Canada
Maple Leaf Clinic
Toronto, Ontario, Canada
Sunnybrook Hospital
Toronto, Ontario, Canada
Montreal General Hospital
Montreal, Quebec, Canada
Centre Hospitalier de l'université de Laval
Ste-Foy, Quebec, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Julio Montaner, MD
University of British Columbia/Providence Health Care
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 31, 2005
First Posted
September 2, 2005
Study Start
January 1, 2004
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
September 25, 2008
Record last verified: 2008-09