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- Klinische proef NCT00000890
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.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving
Contacten en locaties
Studie Locaties
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San Juan, Puerto Rico, 009365067
- Univ of Puerto Rico
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California
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Los Angeles, California, Verenigde Staten, 900331079
- Univ of Southern California / LA County USC Med Ctr
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San Diego, California, Verenigde Staten, 921036325
- Univ of California / San Diego Treatment Ctr
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San Francisco, California, Verenigde Staten, 94115
- Stanford at Kaiser / Kaiser Permanente Med Ctr
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Stanford, California, Verenigde Staten, 943055107
- Stanford Univ Med Ctr
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District of Columbia
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Washington, District of Columbia, Verenigde Staten, 20059
- Howard Univ
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Georgia
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Atlanta, Georgia, Verenigde Staten, 30308
- Emory Univ
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Hawaii
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Honolulu, Hawaii, Verenigde Staten, 96816
- Queens Med Ctr
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Illinois
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Chicago, Illinois, Verenigde Staten, 60611
- Northwestern Univ Med School
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Chicago, Illinois, Verenigde Staten, 60612
- Cook County Hosp
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Louisiana
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New Orleans, Louisiana, Verenigde Staten, 70112
- Tulane Univ School of Medicine
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New Orleans, Louisiana, Verenigde Staten, 70112
- Charity Hosp / Tulane Univ Med School
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Massachusetts
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Boston, Massachusetts, Verenigde Staten, 02215
- Beth Israel Deaconess - West Campus
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Boston, Massachusetts, Verenigde Staten, 02215
- Beth Israel Deaconess Med Ctr
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New York
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New York, New York, Verenigde Staten, 10003
- Beth Israel Med Ctr
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New York, New York, Verenigde Staten, 10021
- Cornell Univ Med Ctr
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New York, New York, Verenigde Staten, 10021
- Chelsea Ctr
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Ohio
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Cleveland, Ohio, Verenigde Staten, 44106
- Case Western Reserve Univ
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Columbus, Ohio, Verenigde Staten, 432101228
- Ohio State Univ Hosp Clinic
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Pennsylvania
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Philadelphia, Pennsylvania, Verenigde Staten, 19104
- Univ of Pennsylvania at Philadelphia
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Washington
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Seattle, Washington, Verenigde Staten, 981224304
- Univ of Washington
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Medewerkers en onderzoekers
Onderzoekers
- Studie stoel: C Shikuma
- Studie stoel: F Sattler
Publicaties en nuttige links
Algemene publicaties
- 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.
Studie record data
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- RNA-virusinfecties
- Virusziekten
- Infecties
- Door bloed overgedragen infecties
- Overdraagbare ziekten
- Seksueel overdraagbare aandoeningen, viraal
- Seksueel overdraagbare aandoeningen
- Lentivirus-infecties
- Retroviridae-infecties
- Immunologische deficiëntie syndromen
- Ziekten van het immuunsysteem
- HIV-infecties
Andere studie-ID-nummers
- ACTG 892
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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