Status:
COMPLETED
The Switch Study: The Role of Lamivudine/Emtricitabine (3TC/FTC) in Antiretroviral Regimens
Lead Sponsor:
Stanford University
Collaborating Sponsors:
Santa Clara Valley Health & Hospital System
University of California, Davis
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
NA
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 re...
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
End Date :
August 1 2005
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00152061
Start Date
January 1 2005
End Date
August 1 2005
Last Update
June 19 2013
Active Locations (1)
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1
Santa Clara Medical Center, PACE Clinic
San Jose, California, United States, 95128