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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
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Prema Menezes, PhD, PA-C, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01701895
First received: October 2, 2012
Last updated: September 15, 2014
Last verified: September 2014

October 2, 2012
September 15, 2014
October 2012
September 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01701895 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
  • 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 ]
Same as current
 
Assessing Short and Long Term Compliance With Caloric Intake in HIV Positive Women Taking Complera
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

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

HIV-1 Infection
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
December 2015
September 2015   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact: Erin Hoffman, BS 919-843-0720 erin_hoffman@med.unc.edu
Contact: Miriam Chicurel-Bayard, RN, BSN 919-843-9922 miriam_chicurel@med.unc.edu
United States
 
NCT01701895
CID 1213 - IRB 12-1550
No
Prema Menezes, PhD, PA-C, University of North Carolina, Chapel Hill
Prema Menezes, PhD, PA-C
Gilead Sciences
Principal Investigator: Prema Menezes, PhD, PA-C University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP