View Clinical Trial (Medical Research Study)
Nucleoside Switch Pilot for Virologically Controlled HIV Subjects With Decreasing CD4 Cells Who Have Received TDF-based ARV Therapy
| City: |
|
Houston |
| State: |
|
Texas |
| Zip Code: |
|
77004 |
| Conditions: |
|
HiV1- Positive |
| Purpose: |
|
The purpose of this study is to assess the safety, tolerability, and antivira activity of
Epzicom in virologically controlled HIV subjects.
|
| Study Summary: |
|
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.
|
| 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.
|
| NCT ID: |
|
NCT01608269 |
| Primary Contact: |
|
Bernie Miguel, BS
Phone: 713-526-9821
Email: research@josephgathe.com
|
| Backup Contact: |
|
N/A |
| Location Contact: |
|
Houston, Texas 77004
United States
Bernie A. Miguel, BS
Phone: 713-526-9821
Email: research@josephgathe.com
Site Status: Recruiting |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
May 20, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|