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

This study has suspended participant recruitment.
(Enrollment.)
Sponsor:
Collaborator:
CIHR Canadian HIV Trials Network
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00143728
First received: August 31, 2005
Last updated: September 24, 2008
Last verified: September 2008

August 31, 2005
September 24, 2008
January 2004
May 2010   (final data collection date for primary outcome measure)
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 ]
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.
Complete list of historical versions of study NCT00143728 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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.
Not Provided
Not Provided
 
3TC or No 3TC for HIV With 3TC Resistance
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
Drug: Lamivudine
See Detailed Description.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
152
May 2010
May 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00143728
P03-0051, CTN 189
Not Provided
Dr. Julio Montaner, University of British Columbia
University of British Columbia
CIHR Canadian HIV Trials Network
Principal Investigator: Julio Montaner, MD University of British Columbia/Providence Health Care
University of British Columbia
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP