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

NCT00152061 | Completed

• 3 other identifiers: 74009IRB protocol 74009SPO number 25036
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

HIV; Antiretroviral Drug Resistance; Treatment Experienced

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• 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.

Interventions

3TC and FTC DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Stanford University: lead
• Santa Clara Valley Health & Hospital System: collaborator
• University of California, Davis: collaborator

Study Sites (1)

Santa Clara Medical Center, PACE Clinic

San Jose, California, 95128, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Racivir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Andrew Zolopa, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 9, 2005
• Study Start: January 1, 2005
• Study Completion: August 1, 2005
• Last Updated: June 19, 2013

Record last verified: 2013-06

Locations

US (1)