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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00143728
Recruitment Status : Suspended (Enrollment.)
First Posted : September 2, 2005
Last Update Posted : September 25, 2008
CIHR Canadian HIV Trials Network
Information provided by:
University of British Columbia

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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Lamivudine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 152 participants
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
Study Start Date : January 2004
Estimated Primary Completion Date : May 2010
Estimated Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Lamivudine

Intervention Details:
  • Drug: Lamivudine
    See Detailed Description.

Primary Outcome Measures :
  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. [ Time Frame: 24 weeks ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00143728

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Canada, British Columbia
Downtown IDC
Vancouver, British Columbia, Canada
Cool Aid Community Health Centre
Victoria, British Columbia, Canada
Canada, Manitoba
St. Boniface General Hospital
Winnipeg, Manitoba, Canada
Canada, Ontario
McMaster University
Hamilton, Ontario, Canada
Haven Program
Sudbury, Ontario, Canada
Maple Leaf Clinic
Toronto, Ontario, Canada
Sunnybrook Hospital
Toronto, Ontario, Canada
Canada, Quebec
Montreal General Hospital
Montreal, Quebec, Canada
Centre Hospitalier de l'université de Laval
Ste-Foy, Quebec, Canada
Sponsors and Collaborators
University of British Columbia
CIHR Canadian HIV Trials Network
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Principal Investigator: Julio Montaner, MD University of British Columbia/Providence Health Care
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Responsible Party: Dr. Julio Montaner, University of British Columbia Identifier: NCT00143728    
Other Study ID Numbers: P03-0051
CTN 189
First Posted: September 2, 2005    Key Record Dates
Last Update Posted: September 25, 2008
Last Verified: September 2008
Keywords provided by University of British Columbia:
Treatment Experienced
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents