3TC or No 3TC for HIV With 3TC Resistance
Information source: University of British Columbia
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Lamivudine (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University of British Columbia Official(s) and/or principal investigator(s):
Julio Montaner, MD, Principal Investigator, Affiliation: University of British Columbia/Providence Health Care
Overall contact:
Sophie Geeraerts, Phone: 604-806-8758, Email: sophie@hivnet.ubc.ca
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.
Clinical Details
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 design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Primary outcome: 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: 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Sophie Geeraerts, Phone: 604-806-8758, Email: sophie@hivnet.ubc.ca
Downtown IDC, Vancouver, British Columbia, Canada; Recruiting
Brian Conway, MD, Phone: 604-642-6429
Cool Aid Community Health Centre, Victoria, British Columbia, Canada; Recruiting
Chris Fraser, Phone: 250-385-1466
St. Boniface General Hospital, Winnipeg, Manitoba, Canada; Not yet recruiting
Stuart Rosser, MD, Phone: 204-237-2948
Maple Leaf Clinic, Toronto, Ontario, Canada; Recruiting
Mona Loutfy, MD, Phone: 416-949-3905
Sunnybrook Hospital, Toronto, Ontario, Canada; Recruiting
Anita Rachlis, MD, Phone: 416-480-4689
Haven Program, Sudbury, Ontario, Canada; Recruiting
Roger Sandre, MD, Phone: 705-523-7059
McMaster University, Hamilton, Ontario, Canada; Recruiting
Sharon Walsley, MD, Phone: 416-340-3871
Montreal General Hospital, Montreal, Quebec, Canada; Recruiting
Julian Falutz, MD, Phone: 514-934-8070
Centre Hospitalier de l’université de Laval, Ste Foy, Quebec, Canada; Recruiting
Sylvie Trottier, MD, Phone: 418-654-2705
Additional Information
Starting date: January 2004
Last updated: October 19, 2005
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