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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University of North Carolina, Chapel Hill
Gilead Sciences
Information provided by (Responsible Party):
Prema Menezes, PhD, PA-C, University of North Carolina, Chapel Hill Identifier:
First received: October 2, 2012
Last updated: September 15, 2014
Last verified: September 2014

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-1 Infection

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: CID 1213 - Assessing Short and Long Term Compliance With Caloric Intake in HIV Positive Women After Switching to Fixed Dose Combination of Rilpivirine, Emtricitabine and Tenofovir DF

Resource links provided by NLM:

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Compliance with meal instruction [ Time Frame: once per month over 48 weeks ] [ Designated as safety issue: No ]
    Compliance will be assessed monthly by a subject-completed food diary and phone assessments.

Secondary Outcome Measures:
  • 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.

Other Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: October 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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 may or may not be of child bearing potential.


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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01701895

Contact: Erin Hoffman, BS 919-843-0720
Contact: Miriam Chicurel-Bayard, RN, BSN 919-843-9922

United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599-7215
Contact: Erin Hoffman, BS    919-843-0720   
Contact: Miriam Chicurel-Bayard, RN, BSN    919-843-9922   
Principal Investigator: Prema Menezes, PhD, PA-C         
Sub-Investigator: Joseph J Eron, Jr., MD         
Sub-Investigator: David A Wohl, MD         
Sub-Investigator: Cheryl Marcus, RN, BSN         
Sponsors and Collaborators
Prema Menezes, PhD, PA-C
Gilead Sciences
Principal Investigator: Prema Menezes, PhD, PA-C University of North Carolina, Chapel Hill
  More Information

Additional Information:
Responsible Party: Prema Menezes, PhD, PA-C, Clinical Assistant Professor of Medicine, University of North Carolina, Chapel Hill Identifier: NCT01701895     History of Changes
Other Study ID Numbers: CID 1213 - IRB 12-1550
Study First Received: October 2, 2012
Last Updated: September 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
women processed this record on February 27, 2015