Trial record 20 of 22 for:    " April 25, 2012":" May 25, 2012"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Therapeutic Concepts.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Therapeutic Concepts
ClinicalTrials.gov Identifier:
NCT01608269
First received: May 25, 2012
Last updated: May 29, 2012
Last verified: May 2012
  Purpose

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


Condition Intervention Phase
HiV1- Positive
Drug: Abacavir/Lamivudine
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Nucleoside Switch Pilot for Virologically Controlled HIV Subjects With Decreasing CD4 Cells Who Have Received TDF-based ARV Therapy

Resource links provided by NLM:


Further study details as provided by Therapeutic Concepts:

Primary Outcome Measures:
  • Efficacy. [ Time Frame: 1 years ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • Safety [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Adverse events and treatment limiting toxicities at all time points.


Estimated Enrollment: 30
Study Start Date: November 2010
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
ABC/3TC (Epzicom), NRTI Drug: Abacavir/Lamivudine
one tablet once a day
Other Name: ABC/3TC

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01608269

Contacts
Contact: Bernie Miguel, BS 713-526-9821 research@josephgathe.com

Locations
United States, Texas
Therapeutic Concepts, PA Recruiting
Houston, Texas, United States, 77004
Contact: Bernie A. Miguel, BS    713-526-9821    research@josephgathe.com   
Principal Investigator: Joseph C. Gathe, Jr., MD         
Sponsors and Collaborators
Therapeutic Concepts
  More Information

No publications provided

Responsible Party: Therapeutic Concepts
ClinicalTrials.gov Identifier: NCT01608269     History of Changes
Other Study ID Numbers: 101-002
Study First Received: May 25, 2012
Last Updated: May 29, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lamivudine
Abacavir
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on July 31, 2014