Assessing Short and Long Term Compliance With Caloric Intake in HIV Positive Women Taking Complera
Information source: University of North Carolina, Chapel Hill
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV-1 Infection
Phase: N/A
Status: Active, not recruiting
Sponsored by: Prema Menezes, PhD, PA-C Official(s) and/or principal investigator(s): Prema Menezes, PhD, PA-C, Principal Investigator, Affiliation: University of North Carolina, Chapel Hill
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.
Clinical Details
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 design: Observational Model: Case-Only, Time Perspective: Prospective
Primary outcome: Compliance with meal instruction
Secondary outcome: Evaluation of subjects' attitudes toward contraceptionAssociation between caloric intake and virologic suppression Assessment of medication adherence
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
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.
Locations and Contacts
University of North Carolina at Chapel Hill, Chapel Hill, North Carolina 27599-7215, United States
Additional Information
SF-36® Health Survey Update by John E. Ware, Jr., Ph.D.
Related publications: 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 http://www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf. Accessed 20Jun2011 Bartlett JA, Fath MJ, Demasi R, Hermes A, Quinn J, Mondou E, Rousseau F. An updated systematic overview of triple combination therapy in antiretroviral-naive HIV-infected adults. AIDS. 2006 Oct 24;20(16):2051-64. Review. El-Ibiary SY, Cocohoba JM. Effects of HIV antiretrovirals on the pharmacokinetics of hormonal contraceptives. Eur J Contracept Reprod Health Care. 2008 Jun;13(2):123-32. doi: 10.1080/13625180701829952. Review. 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 Ford N, Lee J, Andrieux-Meyer I, Calmy A. Safety, efficacy, and pharmacokinetics of rilpivirine: systematic review with an emphasis on resource-limited settings. HIV AIDS (Auckl). 2011;3:35-44. doi: 10.2147/HIV.S14559. Epub 2011 Apr 28. 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 Hodder SL, Mounzer K, Dejesus E, Ebrahimi R, Grimm K, Esker S, Ecker J, Farajallah A, Flaherty JF; AI266073 Study Group. Patient-reported outcomes in virologically suppressed, HIV-1-Infected subjects after switching to a simplified, single-tablet regimen of efavirenz, emtricitabine, and tenofovir DF. AIDS Patient Care STDS. 2010 Feb;24(2):87-96. doi: 10.1089/apc.2009.0259. Walsh JC, Mandalia S, Gazzard BG. Responses to a 1 month self-report on adherence to antiretroviral therapy are consistent with electronic data and virological treatment outcome. AIDS. 2002 Jan 25;16(2):269-77. Giordano TP, Guzman D, Clark R, Charlebois ED, Bangsberg DR. Measuring adherence to antiretroviral therapy in a diverse population using a visual analogue scale. HIV Clin Trials. 2004 Mar-Apr;5(2):74-9. Prins M, Meyer L, Hessol NA. Sex and the course of HIV infection in the pre- and highly active antiretroviral therapy eras. AIDS. 2005 Mar 4;19(4):357-70. Review. Justice AC, Holmes W, Gifford AL, Rabeneck L, Zackin R, Sinclair G, Weissman S, Neidig J, Marcus C, Chesney M, Cohn SE, Wu AW; Adult AIDS Clinical Trials Unit Outcomes Committee. Development and validation of a self-completed HIV symptom index. J Clin Epidemiol. 2001 Dec;54 Suppl 1:S77-90.
Starting date: October 2012
Last updated: May 4, 2015
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