A Study to Evaluate the Effect of Anti-HIV Therapy on Lean Tissue (Muscle) in HIV-Positive Patients
Effect of Highly Active Antiretroviral Therapy (HAART) on Lean Body Mass
The purpose of this study is to determine whether HIV-positive patients with extremely low viral loads (level of HIV in the blood) have a greater gain in lean tissue during anti-HIV (antiretroviral) therapy than patients with higher viral loads.
Many HIV-positive patients experience changes in body composition (muscle, fat, etc.) while on antiretroviral therapy. However, any weight gained while taking antiretrovirals is mostly fat. A patient's viral load may affect whether weight gained is a result of increased fat or increased muscle. A large-scale study is needed to closely evaluate the effects of antiretroviral therapy on body composition.
調査の概要
状態
条件
詳細な説明
Effective antiretroviral therapy, as measured by a decrease in HIV-1 RNA levels, may sustain or improve important components of body composition, perhaps through a decrease in the underlying pro-inflammatory activity and resting energy expenditure. Moderate weight gain has been reported to be associated with HAART. Meaningful increase in total body weight, however, may need to be comprised of augmentation of lean body mass (primarily muscle), since mortality in HIV and cancer wasting is associated with sizable decreases in lean body mass (LBM) and there is no evidence that increases in fat cell mass are protective. To date, there has not been any large-scale prospective evaluation of the effects of HAART on body composition. Nor has it been determined whether increasing body weight or specific components of body composition (fat or lean body mass) in persons who have lost substantive amounts of weight protects against AIDS-defining complications or prolongs survival.
This is a 48-week, observational study of lean body mass, appetite, functional performance, and systemic markers of inflammation during highly active antiretroviral therapy (HAART) in patients co-enrolled in ACTG antiretroviral studies. Patients are stratified by body mass index (BMI) into 2 cohorts: less than 23 kg/m2 versus greater than or equal to 23 to 28 kg/m2. At selected study visits, times of antiretroviral medication change, and following the diagnosis of an AIDS-defining event, the following are assessed: height (screening visit only), weight, lean body mass, appetite (by questionnaire), functional performance (by questionnaire), and markers of systemic inflammation.
研究の種類
入学
連絡先と場所
研究場所
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California
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Los Angeles、California、アメリカ、900331079
- Univ of Southern California / LA County USC Med Ctr
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San Diego、California、アメリカ、921036325
- Univ of California / San Diego Treatment Ctr
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San Francisco、California、アメリカ、94115
- Stanford at Kaiser / Kaiser Permanente Med Ctr
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Stanford、California、アメリカ、943055107
- Stanford Univ Med Ctr
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District of Columbia
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Washington、District of Columbia、アメリカ、20059
- Howard Univ
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Georgia
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Atlanta、Georgia、アメリカ、30308
- Emory Univ
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Hawaii
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Honolulu、Hawaii、アメリカ、96816
- Queens Med Ctr
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Illinois
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Chicago、Illinois、アメリカ、60611
- Northwestern Univ Med School
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Chicago、Illinois、アメリカ、60612
- Cook County Hosp
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Louisiana
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New Orleans、Louisiana、アメリカ、70112
- Tulane Univ School of Medicine
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New Orleans、Louisiana、アメリカ、70112
- Charity Hosp / Tulane Univ Med School
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Massachusetts
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Boston、Massachusetts、アメリカ、02215
- Beth Israel Deaconess - West Campus
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Boston、Massachusetts、アメリカ、02215
- Beth Israel Deaconess Med Ctr
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New York
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New York、New York、アメリカ、10003
- Beth Israel Med Ctr
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New York、New York、アメリカ、10021
- Cornell Univ Med Ctr
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New York、New York、アメリカ、10021
- Chelsea Ctr
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Ohio
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Cleveland、Ohio、アメリカ、44106
- Case Western Reserve Univ
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Columbus、Ohio、アメリカ、432101228
- Ohio State Univ Hosp Clinic
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104
- Univ of Pennsylvania at Philadelphia
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Washington
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Seattle、Washington、アメリカ、981224304
- Univ of Washington
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San Juan、プエルトリコ、009365067
- Univ of Puerto Rico
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria
Patients may be eligible for this study if they:
- Are enrolled in an adult AIDS clinical trial.
- Are HIV-positive.
- Have a viral load of at least 10,000 copies/ml.
- Are expected to live at least 6 months.
- Are at least 18 years old.
Exclusion Criteria
Patients will not be eligible for this study if they:
- Have a history of diabetes requiring medication.
- Have a history of heart disorders.
- Have a fever, diarrhea, nausea, or a condition which makes it difficult to eat within the 14 days prior to study entry.
- Have swelling due to any cause.
- Are pregnant or breast-feeding.
- Are receiving any therapy to increase your appetite or gain weight within 30 days prior to study entry.
- Are receiving any therapy for a severe infection or medical illness within 14 days prior to study entry.
- Are taking certain medications.
研究計画
研究はどのように設計されていますか?
デザインの詳細
協力者と研究者
捜査官
- スタディチェア:C Shikuma
- スタディチェア:F Sattler
出版物と役立つリンク
一般刊行物
- Sattler FR, Schroeder ET, Dube MP, Jaque SV, Martinez C, Blanche PJ, Azen S, Krauss RM. Metabolic effects of nandrolone decanoate and resistance training in men with HIV. Am J Physiol Endocrinol Metab. 2002 Dec;283(6):E1214-22. doi: 10.1152/ajpendo.00189.2002. Epub 2002 Aug 27.
- Shikuma CM, Zackin R, Sattler F, Mildvan D, Nyangweso P, Alston B, Evans S, Mulligan K; AIDS Clinical Trial Group 892 Team. Changes in weight and lean body mass during highly active antiretroviral therapy. Clin Infect Dis. 2004 Oct 15;39(8):1223-30. doi: 10.1086/424665. Epub 2004 Sep 27.
研究記録日
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
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。
HIV感染症の臨床試験
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French National Agency for Research on AIDS and...Elizabeth Glaser Pediatric AIDS Foundation完了パートナーの HIV 検査 | カップルの HIV カウンセリング | カップルのコミュニケーション | HIV の発生率カメルーン, ドミニカ共和国, グルジア, インド
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Erasmus Medical Centerまだ募集していません
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University of Maryland, Baltimore引きこもった
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Hospital Clinic of Barcelona完了
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University of WashingtonNational Institute of Mental Health (NIMH)募集