Back to resultsThe Switch Study: The Role of Lamivudine/Emtricitabine (3TC/FTC) in Antiretroviral Regimens
Primary Purpose
HIV Infections
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
3TC and FTC
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV, Antiretroviral Drug Resistance, Treatment Experienced
Eligibility Criteria
Inclusion Criteria: HIV-1 seropositive patients >= 18 years of age Willingness and ability to understand and sign a written informed consent and comply with the protocol procedure Prior treatment with nucleoside reverse transcriptase inhibitors (NRTI's), non-nucleoside reverse transcriptase inhibitors (NNRTI's) and protease inhibitor (PI)-containing regimens On a stable PI and 3TC or FTC -containing regimen for >= 2 months Plasma HIV-1 RNA >5000 copies/ml CD4 >100 Documented M184V or I on genotype within 3 months of study entry At least 3 PI-associated resistance mutations on genotype within 3 months of study entry, (including known resistance mutations at codons 10, 30, 46, 50, 54, 71, 82, 84, and 90) Exclusion Criteria: In the opinion of the investigator a patient that is either unwilling or unable to be adherent to antiretroviral drugs Requirement for concomitant treatment with medicines that interfere with the therapy prescribed in the study Patients who have never taken 3TC or FTC, or with no prior documentation of the M184V mutation Active hepatitis B infection Vaccination within 2 weeks of entering the study An acute opportunistic illness within 4 weeks of entering the study; chronic infections will not be excluded Use of immunomodulatory medications such as IL-2 Planned use of enfuvirtide, (T20) in salvage regimen, (in T20 naïve subjects)
Sites / Locations
- Santa Clara Medical Center, PACE Clinic
Outcomes
Primary Outcome Measures
To evaluate the role of lamivudine, (3TC), and emtricitabine, (FTC), in salvage regimens in patients with prior 3TC/FTC use, documented resistance to 3TC/FTC, and ongoing viremia as assessed by:
Impact on the initial rate of change in HIV-1 viral load after removing 3TC/FTC from the failing regimen, and
Overall change from baseline in HIV-1 viral load at 24 weeks (HIV-VL AUC 24 wks).
Secondary Outcome Measures
To evaluate the impact of continued versus discontinued 3TC/FTC on the prevalence, frequency and dynamics of the M184V/I amino acid substitution over 24 weeks.
To determine the proportion of patients failing and/or not responding to therapy after 24 weeks as defined by failure to achieve HIV-1 viral load less than 400 copies/ml and/or less than 50 copies/ml
To assess the changes from baseline in absolute CD4 (and CD8) cell counts at 24 weeks.
Full Information
NCT ID
NCT00152061
First Posted
September 8, 2005
Last Updated
June 18, 2013
Sponsor
Stanford University
Collaborators
Santa Clara Valley Health & Hospital System, University of California, Davis
1. Study Identification
Unique Protocol Identification Number
NCT00152061
Brief Title
The Switch Study: The Role of Lamivudine/Emtricitabine (3TC/FTC) in Antiretroviral Regimens
Official Title
The Role of 3TC/FTC in Partially Suppressive Antiretroviral Regimens: The Switch Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University
Collaborators
Santa Clara Valley Health & Hospital System, University of California, Davis
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
In this study the researchers will be enrolling patients who are failing their current antiretroviral regimen who also have resistance to 3TC or FTC. Patients will have their current antiretroviral regimen changed based on resistance testing and also be randomly assigned to either include, or not include 3TC/FTC in this new regimen. The purpose of the research is to investigate whether the change in therapy results in a decrease in the amount of virus particles and an increase in the CD4 cell count. In addition the researchers are investigating the relationship between the existence of resistance and the rate of decrease in viral load, and also to determine if continuing 3TC/FTC (despite being resistant to the medications) has any effect on the rate of decrease of viral load, or effect on CD4 counts.
Detailed Description
In this randomized, open-label, controlled trial, HIV-infected patients who are failing 3TC/FTC-containing highly active antiretroviral therapy, (HAART), will be offered individual treatment selection based on best clinical judgment and genotypic HIV-RNA resistance analysis. Patients who meet entry criteria will first be randomized to either continue or discontinue 3TC/FTC while they remain on their current therapy. HIV-1 viral load will be measured 4 times over a period of 14 days to determine the virologic response to this change. At day 14, each patient's regimen will be optimized to a new combination based on a genotype test taken at study entry. Patients will then start on the new salvage regimen, including or not including 3TC/FTC based on their initial randomization. Additional HIV-1 viral load measurements will be obtained to determine the virologic response to the new salvage regimen over 24 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, Antiretroviral Drug Resistance, Treatment Experienced
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
3TC and FTC
Primary Outcome Measure Information:
Title
To evaluate the role of lamivudine, (3TC), and emtricitabine, (FTC), in salvage regimens in patients with prior 3TC/FTC use, documented resistance to 3TC/FTC, and ongoing viremia as assessed by:
Title
Impact on the initial rate of change in HIV-1 viral load after removing 3TC/FTC from the failing regimen, and
Title
Overall change from baseline in HIV-1 viral load at 24 weeks (HIV-VL AUC 24 wks).
Secondary Outcome Measure Information:
Title
To evaluate the impact of continued versus discontinued 3TC/FTC on the prevalence, frequency and dynamics of the M184V/I amino acid substitution over 24 weeks.
Title
To determine the proportion of patients failing and/or not responding to therapy after 24 weeks as defined by failure to achieve HIV-1 viral load less than 400 copies/ml and/or less than 50 copies/ml
Title
To assess the changes from baseline in absolute CD4 (and CD8) cell counts at 24 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
HIV-1 seropositive patients >= 18 years of age
Willingness and ability to understand and sign a written informed consent and comply with the protocol procedure
Prior treatment with nucleoside reverse transcriptase inhibitors (NRTI's), non-nucleoside reverse transcriptase inhibitors (NNRTI's) and protease inhibitor (PI)-containing regimens
On a stable PI and 3TC or FTC -containing regimen for >= 2 months
Plasma HIV-1 RNA >5000 copies/ml
CD4 >100
Documented M184V or I on genotype within 3 months of study entry
At least 3 PI-associated resistance mutations on genotype within 3 months of study entry, (including known resistance mutations at codons 10, 30, 46, 50, 54, 71, 82, 84, and 90)
Exclusion Criteria:
In the opinion of the investigator a patient that is either unwilling or unable to be adherent to antiretroviral drugs
Requirement for concomitant treatment with medicines that interfere with the therapy prescribed in the study
Patients who have never taken 3TC or FTC, or with no prior documentation of the M184V mutation
Active hepatitis B infection
Vaccination within 2 weeks of entering the study
An acute opportunistic illness within 4 weeks of entering the study; chronic infections will not be excluded
Use of immunomodulatory medications such as IL-2
Planned use of enfuvirtide, (T20) in salvage regimen, (in T20 naïve subjects)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Zolopa, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Santa Clara Medical Center, PACE Clinic
City
San Jose
State/Province
California
ZIP/Postal Code
95128
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Switch Study: The Role of Lamivudine/Emtricitabine (3TC/FTC) in Antiretroviral Regimens
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