Nucleoside Switch Pilot for Virologically Controlled HIV Subjects With Decreasing CD4 Cells Who Have Received TDF-based ARV Therapy (EPZSwitch)

The purpose of this study is to assess the safety, tolerability, and antivira activity of Epzicom in virologically controlled HIV subjects.

Study Overview

• Status: Completed
• Conditions: HiV1- Positive
• Intervention / Treatment: Drug: Abacavir/Lamivudine

Detailed Description

Utilizing the ABC/3TC FDC tablets as the NRTI backbone, this open label study will compare the safety and efficacy of ABC/3TC when used as replacement for subjects with suboptimal CD4- cells count who are receiving TDF/FTC. TYhis study will be conducted for 48 weeks in HIV infected, HLA*B5701 begative subjects who were initially suppressed on a HAART regiment that includes TDF/FTC QD.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77004
      • Therapeutic Concepts, PA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• HIV-1 RNA ≤ 50 copies/mL by HIV-1 Ultrasensitive RNA, Quantitative.
• Treatment experienced subjects on virologically stable HAART regimen containing tenofovir-emtricitabine or tenofovir-lamivudine.

• Subject with CD4 cells that do not increase by 15% and/or that decrease by 15% over previous 12 months period.

  -≥ 18 years of age

• Cognitive ability to understand and provide written informed consent and willingness to participate in and comply with the study protocol
• Less than 7 days of prior ART with any licensed or investigational compound
• Patient does not currently have or has not been treated for an active opportunistic infection (OI) consistent with CDC definition (Appendix C) within 30 days of screening
• Vital signs, physical examination and laboratory results do not exhibit evidence of acute illness
• A female is eligible to enter and participate in this study if she is of:
• Non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal) or
• Child-bearing potential, has a negative serum pregnancy test at screen, and agrees to one of the following:
• Complete abstinence from intercourse from 2 weeks prior to administration of the study drug, throughout the study, and for at least 2 weeks after completion or premature discontinuation from the study to account for elimination of the investigational drug. Should a patient decide to become sexually active during the course of the study, she must be counseled and be willing to use one of the birth control methods listed below:
• Double barrier method (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide)
• Any intrauterine device (IUD) with published data showing that the expected failure rate is <1% per year (not all IUDs meet this criterion)
• Sterilization (female patient or male partner of female patient)
• Any other methods with published data showing that the lowest expected failure rate for that method is <1% per year.

Exclusion Criteria:

• Patient with active AIDS-defining opportunistic infection or disease according to the 1993 CDC AIDS surveillance definition (Clinical Category C) in the 30 days prior to baseline and that, in the opinion of the investigator, would preclude the patient from participating in the study (See Appendix C).
• Patient who are HLA B5701 Positive
• Patient who are determined to have ≥2 thymidine analog mutations to RT
• History of active substance abuse, excluding cannabis, or psychiatric illness that, in the opinion of the investigator, would preclude compliance with protocol, dosing schedule and assessments.
• Patient is either pregnant at time of screening evaluation or breast-feeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: ABC/3TC (Epzicom), NRTI	Drug: Abacavir/Lamivudine; one tablet once a day; Other Names: ABC/3TC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy.	Proportion of patients with CD4 changes from baseline at week 24 and 48. Proportion of patients with plasma HIV-1 RNA <75 copies/mL at week 24 and 48	1 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	Adverse events and treatment limiting toxicities at all time points.	1 year

Collaborators and Investigators

• Sponsor: Therapeutic Concepts

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: May 25, 2012
• First Submitted That Met QC Criteria: May 29, 2012
• First Posted (Estimate): May 31, 2012

Study Record Updates

• Last Update Posted (Actual): April 28, 2017
• Last Update Submitted That Met QC Criteria: April 27, 2017
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Lamivudine; Abacavir
• Other Study ID Numbers: 101-002