- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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
Registrering
Kontakter og plasseringer
Studiesteder
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California
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Los Angeles, California, Forente stater, 900331079
- Univ of Southern California / LA County USC Med Ctr
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San Diego, California, Forente stater, 921036325
- Univ of California / San Diego Treatment Ctr
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San Francisco, California, Forente stater, 94115
- Stanford at Kaiser / Kaiser Permanente Med Ctr
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Stanford, California, Forente stater, 943055107
- Stanford Univ Med Ctr
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District of Columbia
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Washington, District of Columbia, Forente stater, 20059
- Howard Univ
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Georgia
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Atlanta, Georgia, Forente stater, 30308
- Emory Univ
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Hawaii
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Honolulu, Hawaii, Forente stater, 96816
- Queens Med Ctr
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Illinois
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Chicago, Illinois, Forente stater, 60611
- Northwestern Univ Med School
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Chicago, Illinois, Forente stater, 60612
- Cook County Hosp
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Louisiana
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New Orleans, Louisiana, Forente stater, 70112
- Tulane Univ School of Medicine
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New Orleans, Louisiana, Forente stater, 70112
- Charity Hosp / Tulane Univ Med School
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Massachusetts
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Boston, Massachusetts, Forente stater, 02215
- Beth Israel Deaconess - West Campus
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Boston, Massachusetts, Forente stater, 02215
- Beth Israel Deaconess Med Ctr
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New York
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New York, New York, Forente stater, 10003
- Beth Israel Med Ctr
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New York, New York, Forente stater, 10021
- Cornell Univ Med Ctr
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New York, New York, Forente stater, 10021
- Chelsea Ctr
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Ohio
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Cleveland, Ohio, Forente stater, 44106
- Case Western Reserve Univ
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Columbus, Ohio, Forente stater, 432101228
- Ohio State Univ Hosp Clinic
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19104
- Univ of Pennsylvania at Philadelphia
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Washington
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Seattle, Washington, Forente stater, 981224304
- Univ of Washington
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San Juan, Puerto Rico, 009365067
- Univ of Puerto Rico
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Samarbeidspartnere og etterforskere
Etterforskere
- Studiestol: C Shikuma
- Studiestol: F Sattler
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ACTG 892
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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