Assessing Short and Long Term Compliance With Caloric Intake in HIV Positive Women Taking Complera

Inclusion Criteria:

1. HIV-1 infection documented by HIV serology or detectable viral load at any point
prior to study entry or other documentation confirming HIV infection. If no
documentation is available to confirm HIV infection, a rapid test may be performed to
document HIV infection.

2. HIV+ female ≥18 years old and obtaining care at UNC Health Care Infectious Diseases
Clinic, Wake County Human Services Clinic, or Durham County Early Intervention
Clinic. Patients receiving care at other clinics may be entered with approval of the
study team.

3. HIV viral load (VL) < 50 copies/ml as measured by any FDA-approved test for
quantifying HIV-1 RNA during the six months prior to study entry (PSE). The timing of
the viral load may be longer than 6 months depending on the schedule of the last
clinic visit attended by the subject. The intent of the protocol was to assess viral
load status at the previous clinic visit which may occur at an interval longer than
six months due to the scheduling constraints of the UNC Infectious Diseases clinic.
Viral loads drawn > than 6 months (but not > 8 months) prior to the study entry visit
are acceptable. A single "blip" of > 50 and < 200 copies/ml is permissible provided
the most recent VL is <50 copies/ml.

4. No documented resistance to FTC, TDF or rilpivirine. Note: genotyping will not be
performed on study. Subjects with no historical genotype will be considered to have
no documented resistance.

5. Able and willing to provide informed consent.

6. In the opinion of the investigator, able to comply with study medication and
procedures, including ability to complete food diary.

7. Willing to receive monthly phone calls.

8. Agreement between ID clinic provider and study team that clinical monitoring and care
of patient will reside with the ID clinic provider. The study responsibility is
limited to providing 48 weeks of Complera.

Exclusion Criteria:

1. Any condition which, in the opinion of the investigator, would be likely to interfere
with ability to take the study medications appropriately and comply with the study
protocol.

2. Current active illness requiring systemic treatment and/or hospitalization until the
individual completes therapy or, in the opinion of the investigator, is clinically
stable on therapy for at least 7 days prior to study entry.

3. Acute viral hepatitis.

4. Known allergy/hypersensitivity to components of the study drugs or their
formulations.

5. Current or expected use of medication on the prohibited medication list.