Assessing Short and Long Term Compliance With Caloric Intake in HIV Positive Women Taking Complera
2015年11月30日 更新者:Prema Menezes, PhD, PA-C
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.
調査の概要
状態
完了
条件
研究の種類
観察的
入学 (実際)
33
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
North Carolina
-
Chapel Hill、North Carolina、アメリカ、27599-7215
- University of North Carolina at Chapel Hill
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
女性
サンプリング方法
非確率サンプル
調査対象母集団
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.
説明
Inclusion Criteria:
- 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.
- 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.
- 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.
- 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.
- Able and willing to provide informed consent.
- In the opinion of the investigator, able to comply with study medication and procedures, including ability to complete food diary.
- Willing to receive monthly phone calls.
- 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:
- 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.
- 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.
- Acute viral hepatitis.
- Known allergy/hypersensitivity to components of the study drugs or their formulations.
- Current or expected use of medication on the prohibited medication list.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか?
デザインの詳細
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Compliance with meal instruction
時間枠:once per month over 48 weeks
|
Compliance will be assessed monthly by a subject-completed food diary and phone assessments.
|
once per month over 48 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Evaluation of subjects' attitudes toward contraception
時間枠:up to 48 weeks
|
Subjects are questioned about their contraceptive choices.
|
up to 48 weeks
|
|
Association between caloric intake and virologic suppression
時間枠:up to 48 weeks
|
up to 48 weeks
|
|
|
Assessment of medication adherence
時間枠:up to 48 weeks
|
Subjects will self-report adherence on a visual analog scale.
|
up to 48 weeks
|
その他の成果指標
結果測定 |
時間枠 |
|---|---|
|
Measurement of change in fasting lipids
時間枠:Week 48
|
Week 48
|
|
Measurement of change in fasting lipids
時間枠:Baseline
|
Baseline
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
協力者
捜査官
- 主任研究者:Prema Menezes, PhD, PA-C、University of North Carolina, Chapel Hill
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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. doi: 10.1310/JFXH-G3X2-EYM6-D6UG.
- 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. doi: 10.1016/s0895-4356(01)00449-8.
- 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. doi: 10.1097/00002030-200201250-00017.
- 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. doi: 10.1097/01.aids.0000247578.08449.ff.
- 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.
- 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 CJ, Molina JM, Cahn P, Clotet B, Fourie J, Grinsztejn B, Wu H, Johnson MA, Saag M, Supparatpinyo K, Crauwels H, Lefebvre E, Rimsky LT, Vanveggel S, Williams P, Boven K; ECHO Study Group; THRIVE Study Group. Efficacy and safety of rilpivirine (TMC278) versus efavirenz at 48 weeks in treatment-naive HIV-1-infected patients: pooled results from the phase 3 double-blind randomized ECHO and THRIVE Trials. J Acquir Immune Defic Syndr. 2012 May 1;60(1):33-42. doi: 10.1097/QAI.0b013e31824d006e.
- 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.
- 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. doi: 10.1097/01.aids.0000161765.75663.27.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2012年10月1日
一次修了 (実際)
2015年10月1日
研究の完了 (実際)
2015年10月1日
試験登録日
最初に提出
2012年10月2日
QC基準を満たした最初の提出物
2012年10月4日
最初の投稿 (見積もり)
2012年10月5日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年12月2日
QC基準を満たした最後の更新が送信されました
2015年11月30日
最終確認日
2015年11月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。