Assessing Short and Long Term Compliance With Caloric Intake in HIV Positive Women Taking Complera
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.
|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|
- 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.
- 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 ]
|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)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01701895
|Contact: Erin Hoffman, BSfirstname.lastname@example.org|
|Contact: Miriam Chicurel-Bayard, RN, BSNemail@example.com|
|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 firstname.lastname@example.org|
|Contact: Miriam Chicurel-Bayard, RN, BSN 919-843-9922 email@example.com|
|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|
|Principal Investigator:||Prema Menezes, PhD, PA-C||University of North Carolina, Chapel Hill|