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.
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록
연락처 및 위치
연구 장소
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California
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Los Angeles, California, 미국, 900331079
- Univ of Southern California / LA County USC Med Ctr
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San Diego, California, 미국, 921036325
- Univ of California / San Diego Treatment Ctr
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San Francisco, California, 미국, 94115
- Stanford at Kaiser / Kaiser Permanente Med Ctr
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Stanford, California, 미국, 943055107
- Stanford Univ Med Ctr
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District of Columbia
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Washington, District of Columbia, 미국, 20059
- Howard Univ
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Georgia
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Atlanta, Georgia, 미국, 30308
- Emory Univ
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Hawaii
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Honolulu, Hawaii, 미국, 96816
- Queens Med Ctr
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Illinois
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Chicago, Illinois, 미국, 60611
- Northwestern Univ Med School
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Chicago, Illinois, 미국, 60612
- Cook County Hosp
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Louisiana
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New Orleans, Louisiana, 미국, 70112
- Tulane Univ School of Medicine
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New Orleans, Louisiana, 미국, 70112
- Charity Hosp / Tulane Univ Med School
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Massachusetts
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Boston, Massachusetts, 미국, 02215
- Beth Israel Deaconess - West Campus
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Boston, Massachusetts, 미국, 02215
- Beth Israel Deaconess Med Ctr
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New York
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New York, New York, 미국, 10003
- Beth Israel Med Ctr
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New York, New York, 미국, 10021
- Cornell Univ Med Ctr
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New York, New York, 미국, 10021
- Chelsea Ctr
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Ohio
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Cleveland, Ohio, 미국, 44106
- Case Western Reserve Univ
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Columbus, Ohio, 미국, 432101228
- Ohio State Univ Hosp Clinic
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19104
- Univ of Pennsylvania at Philadelphia
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Washington
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Seattle, Washington, 미국, 981224304
- Univ of Washington
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San Juan, 푸에르토 리코, 009365067
- Univ of Puerto Rico
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참여기준
자격 기준
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건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
공동 작업자 및 조사자
수사관
- 연구 의자: C Shikuma
- 연구 의자: F Sattler
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 등록 날짜
최초 제출
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처음 게시됨 (추정)
연구 기록 업데이트
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추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .