- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00143728
3TC or No 3TC for HIV With 3TC Resistance
September 24, 2008 updated by: University of British Columbia
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
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 Overview
Study Type
Interventional
Enrollment (Anticipated)
152
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
British Columbia
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Vancouver, British Columbia, Canada
- Downtown IDC
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Victoria, British Columbia, Canada
- Cool Aid Community Health Centre
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-
Manitoba
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Winnipeg, Manitoba, Canada
- St. Boniface General Hospital
-
-
Ontario
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Hamilton, Ontario, Canada
- McMaster University
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Sudbury, Ontario, Canada
- Haven Program
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Toronto, Ontario, Canada
- Sunnybrook Hospital
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Toronto, Ontario, Canada
- Maple Leaf Clinic
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Quebec
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Montreal, Quebec, Canada
- Montreal General Hospital
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Ste-Foy, Quebec, Canada
- Centre Hospitalier de l'Universite de Laval
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percent and absolute change in viral load from baseline to week 24 and week 48.
Time Frame: 48 weeks
|
48 weeks
|
Change in CD4 count in both absolute number and percentage from baseline to week 24 and week 48.
Time Frame: 48 weeks
|
48 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Julio Montaner, MD, University of British Columbia/Providence Health Care
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2004
Primary Completion (Anticipated)
May 1, 2010
Study Completion (Anticipated)
May 1, 2010
Study Registration Dates
First Submitted
August 31, 2005
First Submitted That Met QC Criteria
August 31, 2005
First Posted (Estimate)
September 2, 2005
Study Record Updates
Last Update Posted (Estimate)
September 25, 2008
Last Update Submitted That Met QC Criteria
September 24, 2008
Last Verified
September 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Lamivudine
Other Study ID Numbers
- P03-0051
- CTN 189
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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