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

• Evaluation of subjects' attitudes toward contraception [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]
  Subjects are questioned about their contraceptive choices.
• Association between caloric intake and virologic suppression [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]
• Assessment of medication adherence [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]
  Subjects will self-report adherence on a visual analog scale.

• Measurement of change in fasting lipids [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
• Measurement of change in fasting lipids [ Time Frame: Baseline ] [ Designated as safety issue: No ]

The purpose of this research study is to evaluate how easy it is for female HIV- positive subjects taking Complera to comply with the dietary requirement using a food diary in the short term (4 weeks) and long term (24 weeks and 48 weeks) and to determine association between calorie intake and virologic suppression. A secondary goal of the study is to evaluate subjects' attitudes towards contraception.

HIV positive females ≥ 18 years of age who are currently on Complera with suppressed viral load (VL) defined as having VL <50 copies/ml in the 6 months prior to study entry and no known resistance to FTC, TDF, or rilpivirine. Subjects must be of child bearing potential defined as a premenopausal female capable of becoming pregnant.

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Inclusion Criteria:

1. HIV-1 infection documented by HIV serology or detectable viral load at any point prior to study entry.
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).

   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. Pre-menopausal.
6. Able and willing to provide informed consent.
7. In the opinion of the investigator, able to comply with study medication and procedures, including ability to complete food diary
8. Willing to receive monthly phone calls.
9. 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. Surgical sterilization
2. 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.
3. 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.
4. Acute viral hepatitis.
5. Known allergy/hypersensitivity to components of the study drugs or their formulations.
6. Current or expected use of medication on the prohibited medication list.