Terminé

A Study to Evaluate the Effect of Anti-HIV Therapy on Lean Tissue (Muscle) in HIV-Positive Patients

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Ce qui est collecté

Collecte de données

Qui peut participer

HIV Infections

À partir de 18 ans
Comment se déroule l'étude

Histoire Naturelle

Observation de l'évolution d'une maladie sans intervention médicale, afin de comprendre son déroulement et ses différentes phases.
Observationnel

Résumé

Sponsor principalNational Institute of Allergy and Infectious Diseases (NIAID)
Dernière mise à jour : 24 juin 2005
Issu d'une base de données validée par les autorités. Revendiquer cette étude

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. 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.

Titre officielEffect of Highly Active Antiretroviral Therapy (HAART) on Lean Body Mass 
Sponsor principalNational Institute of Allergy and Infectious Diseases (NIAID)
Dernière mise à jour : 24 juin 2005
Issu d'une base de données validée par les autorités. Revendiquer cette étude

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design
200 participants à inclureNombre total de participants que l'essai clinique vise à recruter.
Histoire Naturelle
Ces études observent la façon dont une maladie évolue naturellement, sans traitement. Elles aident à comprendre son développement, ses effets dans le temps et son impact sur la qualité de vie.

Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères
Tout sexeLe sexe biologique des participants éligibles à s'inscrire.
À partir de 18 ansTranche d'âge des participants éligibles à participer.
Volontaires sains non autorisésIndique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.
Conditions
Pathologie
HIV Infections
Critères

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.



Centres d'étude

Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.
Cette étude comporte 21 sites
Suspendu
Univ of Southern California / LA County USC Med CtrLos Angeles, United StatesVoir le site
Suspendu
Univ of California / San Diego Treatment CtrSan Diego, United States
Suspendu
Stanford at Kaiser / Kaiser Permanente Med CtrSan Francisco, United States
Suspendu
Stanford Univ Med CtrStanford, United States

Terminé21 Centres d'Étude