Terminé

Évaluation des complications pulmonaires dans l'infection par le VIH

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But de l'étude

Cette étude vise à observer et à comprendre les complications pulmonaires (liées aux poumons) chez les individus vivant avec une infection par le VIH.

Ce qui est collecté

Collecte de données

Qui peut participer

Infections transmises par le sang+19

+ Maladies génito-urinaires

+ Maladies Génitales

Jusqu'à 100 ans
Voir tous les critères d'éligibilité
Comment se déroule l'étude

Observationnel
Date de début : septembre 1987
Voir le détail du protocole

Résumé

Sponsor principalNational Heart, Lung, and Blood Institute (NHLBI)
Dernière mise à jour : 16 mars 2016
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Date de début de l'étude : 1 septembre 1987

Date à laquelle le premier participant a commencé l'étude.

BACKGROUND: Pulmonary infections as a group are the most commonly recognized life threatening disorders in patients with the AIDS. Although Pneumocystis carinii was the predominant pulmonary pathogen found in these patients, other organisms were clearly of importance as well, not with early years of the HIV epidemic only in patients with AIDS and ARC but in individuals with asymptomatic HIV infection. In the mid-1980s, physicians who examined many AIDS patients had the impression that a shift was occurring in the types and incidence of pulmonary complications associated with HIV infection. For example, there appeared to be an increased incidence of serious infections caused by pyogenic bacteria and pulmonary and extrapulmonary infection with M. tuberculosis had been noted with increased frequency. Furthermore, lymphoid interstitial pneumonitis (LIP), which is diagnostic of AIDS in children under 13 years old who are HIV antibody positive, was diagnosed with increased frequency in adults. Nonspecific interstitial pneumonitis also appeared to be on the rise. Legionella pneumonia, in contrast to its increased incidence during 1981-83, was now seldom encountered. However, apart from the increased incidence of tuberculosis, a reportable disease, these other shifts in the incidence of pulmonary complications had not been verified. Because diagnostic strategies in the development of new treatment regimens and new approaches for clinical research were dependent upon knowledge of the incidence and natural history of pulmonary complications associated with HIV infection, the collection of such information was important. The Request for Proposals for this initiative was released in January 1987. Awards were made in September 1987. The study was funded jointly by the NHLBI and the NIAID. The study was extended by the cooperative agreement mechanism in FY 1993. DESIGN NARRATIVE: The cohort consisted of 3 groups: Group A HIV seropositive, no symptoms attributable to HIV and CD4+ Cells >= 400 per microliter; Group B HIV seropositive chemical manifestations of HIV in past 6 months or CD4+ Cells < 400 per microliter; and Group C HIV seronegative controls. The pulmonary status of individuals in each of the categories was evaluated by such methods as chest radiography, pulmonary function tests, nuclear medicine studies, and histological and/or microbiological evaluation. The prospective cohort study described the incidence and course of lung diseases at all stages of HIV infection. Six clinical centers from different geographic areas in the United States began enrolling participants in 1988, and the resulting cohort comprised 1,369 members. HIV seropositive participants were randomized to "intensive" (pulmonary disease screening and follow-up at three-month intervals) or "routine" (six-month follow-up intervals with annual screening) follow-up to assess the impact of these strategies on patient outcomes. The contract-supported phase of the study was jointly funded by the NHLBI and the NIAID. In 1992, the NHLBI decided to extend follow-up for another five years. The contractors applied for research grants which were approved by the National Heart, Lung, and Blood Advisory Council in May 1992 and awarded in October, 1992. In the renewal, particular attention was given to identifying patterns of complications among demographic subgroups that had not been extensively studied, such as women and Blacks, and to defining differences between HIV transmission groups. The study ended in May, 1997. The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

NCT00005273
Sponsor principalNational Heart, Lung, and Blood Institute (NHLBI)
Dernière mise à jour : 16 mars 2016
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

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.

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

Homme

Le sexe biologique des participants éligibles à s'inscrire.

Jusqu'à 100 ans

Tranche d'âge des participants éligibles à participer.

Volontaires sains non autorisés

Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.

Conditions

Pathologie

Infections transmises par le sangMaladies génito-urinairesMaladies GénitalesInfections bactériennes et mycosesMaladies TransmissiblesSyndromes de Déficience ImmunologiqueMaladies du Système ImmunitaireInfectionsMycosesMaladies des voies respiratoiresInfections à RetroviridaeInfections à virus ARNMaladies Sexuellement TransmissiblesMaladies à virus lentMaladies viralesMaladies Sexuellement Transmissibles ViralesInfections à LentivirusSyndrome d'Immunodéficience AcquiseComplexe associé au SIDAMaladies pulmonairesInfections à VIHInfections à Pneumocystis

Critères

No eligibility criteria

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.
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TerminéAucun centre d'étude
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