Clinical trial NCT01701895: Assessing Short and Long Term Compliance With Caloric Intake in HIV Positive Women Taking Complera
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV-1 Infection
Keywords: Complera
short-term
long-term
compliance
caloric
intake
HIV
positive
women
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2012-10-05
Enrollment: 33
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Compliance with meal instruction
timeFrame: once per month over 48 weeks
Secondary outcomes:
measure: Evaluation of subjects' attitudes toward contraception
timeFrame: up to 48 weeks
measure: Association between caloric intake and virologic suppression
timeFrame: up to 48 weeks
measure: Assessment of medication adherence
timeFrame: up to 48 weeks
Other outcomes:
measure: Measurement of change in fasting lipids
timeFrame: Week 48
measure: Measurement of change in fasting lipids
timeFrame: Baseline
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Prema Menezes, PhD, PA-C
role: PRINCIPAL_INVESTIGATOR
References:
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