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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
152
See Detailed Description.
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
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
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
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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