The Switch Study: The Role of Lamivudine/Emtricitabine (3TC/FTC) in Antiretroviral Regimens
Completed · Not applicable
Conditions studied: HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00152061
- Run by
- Stanford University
- People needed
- 40
- Starts
- 2005-01-01
- Expected to finish
- 2005-08-01
- Last updated by the study team
- 2013-06-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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)
Where it is running
- Santa Clara Medical Center, PACE Clinic — San Jose, California, United States
Full record on ClinicalTrials.gov
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