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

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.