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

NCT01608269 | Completed Phase 4

• 1 other identifier: 101-002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

HiV1- Positive

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Safety

  1 year

Study Arms (1)

ABC/3TC (Epzicom), NRTI

OTHER

Drug: Abacavir/Lamivudine

Interventions

Abacavir/Lamivudine DRUG

one tablet once a day

Also known as: ABC/3TC

ABC/3TC (Epzicom), NRTI

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Therapeutic Concepts: lead

Study Sites (1)

Therapeutic Concepts, PA

Houston, Texas, 77004, United States

Location

MeSH Terms

Interventions

abacavir, lamivudine drug combination

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2012
• First Posted: May 31, 2012
• Study Start: November 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: April 28, 2017

Record last verified: 2012-05

Locations

US (1)