The Switch Study: The Role of Lamivudine/Emtricitabine (3TC/FTC) in Antiretroviral Regimens
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ClinicalTrials.gov Identifier: NCT00152061 |
Recruitment Status
:
Completed
First Posted
: September 9, 2005
Last Update Posted
: June 19, 2013
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: 3TC and FTC | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | The Role of 3TC/FTC in Partially Suppressive Antiretroviral Regimens: The Switch Study |
Study Start Date : | January 2005 |
Actual Study Completion Date : | August 2005 |

- 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).
- 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.

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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:
- 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)

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): NCT00152061
United States, California | |
Santa Clara Medical Center, PACE Clinic | |
San Jose, California, United States, 95128 |
Principal Investigator: | Andrew Zolopa, MD | Stanford University |
Responsible Party: | Stanford University |
ClinicalTrials.gov Identifier: | NCT00152061 History of Changes |
Other Study ID Numbers: |
74009 IRB protocol 74009 SPO number 25036 |
First Posted: | September 9, 2005 Key Record Dates |
Last Update Posted: | June 19, 2013 |
Last Verified: | June 2013 |
Keywords provided by Stanford University:
HIV Antiretroviral Drug Resistance 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 |