3TC or No 3TC for HIV With 3TC Resistance
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ClinicalTrials.gov Identifier: NCT00143728 |
Recruitment Status
:
Suspended
(Enrollment.)
First Posted
: September 2, 2005
Last Update Posted
: September 25, 2008
|
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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 |

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Drug: Lamivudine
- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
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.

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
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 |
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 |