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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01701895
Recruitment Status : Completed
First Posted : October 5, 2012
Last Update Posted : December 2, 2015
Gilead Sciences
Information provided by (Responsible Party):
Prema Menezes, PhD, PA-C, University of North Carolina, Chapel Hill

Brief Summary:
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.

Condition or disease
HIV-1 Infection

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Study Type : Observational
Actual Enrollment : 33 participants
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
Study Start Date : October 2012
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Primary Outcome Measures :
  1. Compliance with meal instruction [ Time Frame: once per month over 48 weeks ]
    Compliance will be assessed monthly by a subject-completed food diary and phone assessments.

Secondary Outcome Measures :
  1. Evaluation of subjects' attitudes toward contraception [ Time Frame: up to 48 weeks ]
    Subjects are questioned about their contraceptive choices.

  2. Association between caloric intake and virologic suppression [ Time Frame: up to 48 weeks ]
  3. Assessment of medication adherence [ Time Frame: up to 48 weeks ]
    Subjects will self-report adherence on a visual analog scale.

Other Outcome Measures:
  1. Measurement of change in fasting lipids [ Time Frame: Week 48 ]
  2. Measurement of change in fasting lipids [ Time Frame: Baseline ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01701895

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United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7215
Sponsors and Collaborators
Prema Menezes, PhD, PA-C
Gilead Sciences
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Principal Investigator: Prema Menezes, PhD, PA-C University of North Carolina, Chapel Hill
Additional Information:
Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. January 10, 2011; 1-166. Available at Accessed 20Jun2011
Sekar V, Ryan R, Schaible D, et al Pharmacokinetic profile of darunavir co-administered with low-dose ritonavir in treatment-experienced women and men with HIV infection: 4-week analysis in a substudy of the GRACE (Gender, Race, And Clinical Experience) study. 9th International Workshop on Clinical Pharmacology of HIV Therapy. April 7-9, 2008. New Orleans. Abstract O16
Umeh O, Currier J, Park JG et al. Sex differences in lopinavir/ritonavir soft gel capsule pharmacokinetics among HIV infected females and males. Conference on Retroviruses and Opportunistic Infections. February 3-6,2008, Boston, Massachusetts Abstract 786
Cohen C, Molina JM, Cahn P et al, Pooled 48 week efficacy and safety results from ECHO and THRIVE, two double blind randomized Phase III trials comparing TMC 278 vs. efavirenz in treatment naïve HIV-1 infected patients. HIV DART 2010 Abstract 45

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Responsible Party: Prema Menezes, PhD, PA-C, Clinical Assistant Professor of Medicine, University of North Carolina, Chapel Hill Identifier: NCT01701895    
Other Study ID Numbers: CID 1213 - IRB 12-1550
First Posted: October 5, 2012    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: November 2015
Keywords provided by Prema Menezes, PhD, PA-C, University of North Carolina, Chapel Hill:
Additional relevant MeSH terms:
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HIV Seropositivity
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases