3TC or No 3TC for HIV With 3TC Resistance
This study has suspended participant recruitment.
(Enrollment.)
Sponsor:
University of British Columbia
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
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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 4 |
| 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:
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:
-
Drug: Lamivudine
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
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00143728
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
CIHR 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 |
ClinicalTrials.gov processed this record on March 03, 2015