The Switch Study: The Role of Lamivudine/Emtricitabine (3TC/FTC) in Antiretroviral Regimens

• Status: Completed
• Trial end date: 2005-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Collaborators: Santa Clara Valley Health & Hospital System; University of California, Davis

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)