A Study to Assess the Efficacy of Raltegravir (Isentress®), Administered in Combination With Other Antiretroviral Drugs as Treatment for Adults and Older Adults Infected With the Human Immunodeficiency Virus 1 (HIV-1)(MK-0518-145) (Wirksamkeit Von Isentress® Unter Praxisbedingungen) (WIP)
2016年4月15日 更新者：Merck Sharp & Dohme LLC
A Non-interventional Cohort Study for the Assessment of the Efficacy of RALTEGRAVIR 400 mg Administered Twice Daily in Combination With Other Antiretroviral Drugs to Treat Infection With the Human Immunodeficiency Virus 1 (HIV-1) in Adults and Aging Patients (≥ 50 Years) Under Conditions That Are Representative of the Nationwide Treatment of HIV-positive Patients in Germany
This is an observational, non-comparative, multicenter, open-label study.
Participants will be treated with Raltegravir according to standard clinical practice, and monitored over a total period of 96 weeks.
In an extension to the study (Amendment 1), a new cohort of aging participants (≥ 50 years) will be recruited and monitored over a total period of 48 weeks.
Participants who stop taking Raltegravir before the end of the 96-week period or 48-week period, respectively, will be followed up for 3 months after discontinuing the drug.
The primary objective is to determine the proportion of participants with a human immunodeficiency virus (HIV)-1 viral load < 50 copies/mL after 48 weeks of treatment with Raltegravir.
調査の概要
研究の種類
観察的
入学 (実際)
451
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
全て
サンプリング方法
非確率サンプル
調査対象母集団
Adults with confirmed HIV-1 infection
説明
Inclusion Criteria
The prospective participant must meet, at least, all of the criteria below to be eligible for study participation. The participant:
- Is a minimum age of 18 years (adults) or 50 years (aging participants);
- Is male or female;
- Has confirmed infection with HIV-1 (positive HIV test according to appropriate standard practice);
- Has commenced antiretroviral treatment with Raltegravir according to the recommendations made in the Summary of Product Characteristics at the time of enrollment on the study, or a maximum 6 months prior to enrollment on the study;
- Has any cluster of differentiation (CD4) cell (specialized white blood cell) count upon enrollment on the study.
Exclusion criteria
If the prospective participant meets any of the criteria below (among others determined by the study staff) they will NOT be eligible for study participation. The participant:
- For which Raltegravir, or its ingredients, are contraindicated;
- Has intolerance to Raltegravir, or its ingredients;
- If female, is pregnant, breastfeeding, or is planning a pregnancy or egg donation during the study.
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
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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Overall Participants
HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 96 weeks (Initial Cohort), 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
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Raltegravir, 400 mg, per oral (p.o.) twice daily (b.i.d.) for 48 or 144 weeks
他の名前：
Raltegravir, 400 mg, per oral (p.o.) twice daily (b.i.d.) for 96, 144, or 48 weeks
他の名前：
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Aging Participants
HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany. Includes newly enrolled participants ≥ 50 years of age (Amendment Cohort), plus participants from the Initial Cohort who were ≥ 50 years of age at time of recruitment and who completed 48 weeks of treatment (Prolonged Cohort). |
Raltegravir, 400 mg, per oral (p.o.) twice daily (b.i.d.) for 48 or 144 weeks
他の名前：
Raltegravir, 400 mg, per oral (p.o.) twice daily (b.i.d.) for 96, 144, or 48 weeks
他の名前：
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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 |
|---|---|---|
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Percentage of Participants With an HIV-1 Viral Load <50 Copies/mL After 48 Weeks of Raltegravir Treatment
時間枠：Baseline and 48 weeks
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The percentage of participants with an HIV-1 viral load <50 copies/mL of HIV-1 RNA after 48 weeks of raltegravir treatment was determined.
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Baseline and 48 weeks
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Percentage of Aging Participants With an HIV-1 Viral Load <50 Copies/mL After 48 Weeks of Raltegravir Treatment
時間枠：Baseline and 48 weeks
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The percentage of aging participants (>=50 years old at initiation of raltegravir treatment) with an HIV-1 viral load <50 copies/mL of HIV-1 RNA after 48 weeks of raltegravir treatment was determined.
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Baseline and 48 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Percentage of Participants With an HIV-1 Viral Load <50 Copies/mL After 96 Weeks of Raltegravir Treatment
時間枠：Baseline and 96 weeks
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The percentage of participants with an HIV-1 viral load <50 copies/mL of HIV-1 RNA after 96 weeks of raltegravir treatment was determined.
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Baseline and 96 weeks
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HIV-1 Viral Load After 96 Weeks of Raltegravir Treatment
時間枠：Baseline and 96 weeks
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The HIV-1 viral load (log10 copies/mL of HIV-1 RNA) was determined at Baseline and after 96 weeks of raltegravir treatment.
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Baseline and 96 weeks
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Change From Baseline in CD4+ T-cell Counts After 96 Weeks of Raltegravir Treatment
時間枠：Baseline and 96 weeks
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Mean CD4+ T-cell counts were determined at baseline and after 96 weeks of raltegravir treatment.
A positive change from baseline indicates an increase in CD4+ T-cell count.
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Baseline and 96 weeks
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HIV-1 Viral Load in Aging Participants After 48 Weeks of Raltegravir Treatment
時間枠：Baseline and 48 weeks
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The HIV-1 viral load (log10 copies/mL of HIV-1 RNA) was determined in aging participants (>=50 years old at initiation of raltegravir treatment) at Baseline and after 48 weeks of raltegravir treatment.
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Baseline and 48 weeks
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Change From Baseline in CD4+ T-cell Counts in Aging Participants After 48 Weeks of Raltegravir Treatment
時間枠：Baseline and 48 weeks
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Mean CD4+ T-cell counts were determined in aging participants (>=50 years old at initiation of raltegravir treatment) at baseline and after 48 weeks of raltegravir treatment was determined.
A positive change from baseline indicates an increase in CD4+ T-cell count.
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Baseline and 48 weeks
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Change From Baseline in Mean Framingham Risk Score for the 10-Year Cardiovascular Risk in Aging Participants After 48 Weeks of Raltegravir Treatment
時間枠：Baseline and 48 weeks
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Mean Framingham Risk for 10-year cardiovascular risk was determined in aging participants (>=50 years old at initiation of raltegravir treatment).
Points were allotted for each of following 8 risk factors : sex, age, systolic blood pressure, treatment for hypertension, smoking, diabetes, total cholesterol, and high-density lipoprotein.
The sum of the points for each participant was assigned a percent 10-year cardiovascular risk on a lookup table, and could range from 0% to 100%.
The mean Framingham Risk for 10-year cardiovascular risk was then calculated for the analysis population.
The change from baseline was calculated as Baseline minus Week 48; a positive change indicates reduced risk.
This Outcome Measure was added with Amendment 1 and applies only to aging participants.
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Baseline and 48 weeks
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Change From Baseline in Mean D:A:D Risk Score for the 5-Year Cardiovascular Risk in Aging Participants After 48 Weeks of Raltegravir Treatment
時間枠：Baseline and 48 weeks
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Mean Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) Risk Score for 5-year cardiovascular risk was determined in aging participants (>=50 years old at initiation of raltegravir treatment) at Baseline and after 48 weeks of raltegravir treatment.
The score included the following 8 risk factors: sex, age, systolic blood pressure, family cardiovascular disease history, current smoking, previous cigarette smoker, diabetes, total cholesterol, high-density lipoprotein, currently on indinavir, currently on lopinavir, currently on abacavir, duration and current use of indinavir and duration and current use of lopinavir.
The D:A:D Risk Score is interpreted as low: <1%; moderate: 1-5%; high: 5-10%; and very high: >10%.
The change from baseline was calculated as Week 48 minus Baseline; a positive change indicates increased risk.
This Outcome Measure was added with Amendment 1 and applies only to aging participants.
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Baseline and 48 weeks
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Percentage of Aging Participants With Concomitant Diseases at Baseline
時間枠：Baseline
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The percentage of aging participants with Baseline comorbidities was reported.
This Outcome Measure was added with Amendment 1 and applies only to aging participants.
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Baseline
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Percentage of Aging Participants Taking Concomitant Medications at Baseline
時間枠：Baseline
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The percentage of aging participants taking concomitant medication in addition to their other antiretroviral therapy was reported.
This Outcome Measure was added with Amendment 1 and applies only to aging participants.
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Baseline
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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
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
- D'Agostino RB Sr, Vasan RS, Pencina MJ, Wolf PA, Cobain M, Massaro JM, Kannel WB. General cardiovascular risk profile for use in primary care: the Framingham Heart Study. Circulation. 2008 Feb 12;117(6):743-53. doi: 10.1161/CIRCULATIONAHA.107.699579. Epub 2008 Jan 22.
- Anderson KM, Odell PM, Wilson PW, Kannel WB. Cardiovascular disease risk profiles. Am Heart J. 1991 Jan;121(1 Pt 2):293-8. doi: 10.1016/0002-8703(91)90861-b.
- Friis-Moller N, Thiebaut R, Reiss P, Weber R, Monforte AD, De Wit S, El-Sadr W, Fontas E, Worm S, Kirk O, Phillips A, Sabin CA, Lundgren JD, Law MG; DAD study group. Predicting the risk of cardiovascular disease in HIV-infected patients: the data collection on adverse effects of anti-HIV drugs study. Eur J Cardiovasc Prev Rehabil. 2010 Oct;17(5):491-501. doi: 10.1097/HJR.0b013e328336a150.
- Anderson KM, Wilson PW, Odell PM, Kannel WB. An updated coronary risk profile. A statement for health professionals. Circulation. 1991 Jan;83(1):356-62. doi: 10.1161/01.cir.83.1.356. No abstract available.
- Naumann U, Moll A, Schleehauf D, Lutz T, Schmidt W, Jaeger H, Funke B, Witte V. Similar efficacy and tolerability of raltegravir-based antiretroviral therapy in HIV-infected patients, irrespective of age group, burden of comorbidities and concomitant medication: Real-life analysis of the German 'WIP' cohort. Int J STD AIDS. 2017 Aug;28(9):893-901. doi: 10.1177/0956462416679550. Epub 2016 Nov 14. Erratum In: Int J STD AIDS. 2017 Jun;28(7):738.
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
2010年10月1日
一次修了 (実際)
2015年4月1日
研究の完了 (実際)
2015年4月1日
試験登録日
最初に提出
2010年9月30日
QC基準を満たした最初の提出物
2010年9月30日
最初の投稿 (見積もり)
2010年10月4日
学習記録の更新
投稿された最後の更新 (見積もり)
2016年5月23日
QC基準を満たした最後の更新が送信されました
2016年4月15日
最終確認日
2016年4月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 0518-145
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