3TC or No 3TC for HIV With 3TC Resistance
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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. |
| ClinicalTrials.gov Identifier: NCT00143728 |
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Recruitment Status
:
Suspended
(Enrollment.)
First Posted
: September 2, 2005
Last Update Posted
: September 25, 2008
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Sponsor:
University of British Columbia
Collaborator:
CIHR Canadian HIV Trials Network
Information provided by:
University of British Columbia
- Study Details
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- No Results Posted
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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 |
| 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
U.S. FDA Resources
Intervention Details:
-
Drug: Lamivudine
See Detailed Description.
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 ]
Secondary Outcome Measures
:
- Percent and absolute change in viral load from baseline to week 24 and week 48. [ Time Frame: 48 weeks ]
- 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
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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.
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 ClinicalTrials.gov identifier (NCT number): 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 |
| Responsible Party: | Dr. Julio Montaner, University of British Columbia |
| ClinicalTrials.gov Identifier: | NCT00143728 History of Changes |
| 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:
|
HIV Treatment Experienced |
Additional relevant MeSH terms:
|
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Lamivudine 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 |