3TC or No 3TC for HIV With 3TC Resistance - Full Text View

Sponsor:	University of British Columbia
Collaborator:	Canadian HIV Trials Network
Information provided by:	University of British Columbia
ClinicalTrials.gov Identifier:	NCT00143728

Purpose

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	Intervention	Phase
HIV Infections	Drug: Lamivudine	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Lamivudine

U.S. FDA Resources

Further study details as provided by University of British Columbia:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percent and absolute change in viral load from baseline to week 24 and week 48. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Change in CD4 count in both absolute number and percentage from baseline to week 24 and week 48. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	152
Study Start Date:	January 2004
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Intervention Details:

See Detailed Description.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00143728

Locations

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

Canadian HIV Trials Network

Investigators

Principal Investigator:

Julio Montaner, MD

University of British Columbia/Providence Health Care

More Information

No publications provided

Responsible Party:	Dr. Julio Montaner, University of British Columbia
ClinicalTrials.gov Identifier:	NCT00143728 History of Changes
Other Study ID Numbers:	P03-0051, CTN 189
Study First Received:	August 31, 2005
Last Updated:	September 24, 2008
Health Authority:	Canada: Health Canada

Keywords provided by University of British Columbia:

HIV
Treatment Experienced

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

Lamivudine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on February 09, 2012