Effect of Highly Active Antiretroviral Therapy (HAART) on Viral Burden and Immune Function in the Lungs of HIV-Infected Subjects
Collecte de données
Infections transmises par le sang+17
+ Maladies génito-urinaires
+ Maladies Génitales
Étude thérapeutique
Résumé
Date de début de l'étude : 1 août 1999
Date à laquelle le premier participant a commencé l'étude.Lymphocytic alveolitis in HIV-infected patients probably represents a local immune response to HIV-infected cells in the lung. The intensity of lymphocytic alveolitis may therefore reflect the viral load in the lung. If so, treatment that reduces viral load in the lung (e.g., HAART) should also decrease the number of cytotoxic T lymphocytes (CTLs) in the alveolar space and should return pulmonary immune responses toward normal. Patients are stratified by CD4 count: less than 200 cells/mm3 or 200 - 500 cells/mm3. BAL is performed and blood samples are collected prior to initiation of HAART and after 1 and 6 months of HAART. If a patient has detectable HIV in the lung after 6 months of HAART, the patient is asked to submit to an optional fourth BAL after 12 months of HAART. BAL fluid and cells are analyzed for HIV viral load, percent lymphocytes, and lymphocyte subsets. Responses in the lung are compared to simultaneous changes in these variables found in the peripheral blood. Each patient serves as his/her own control.
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.50 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 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
Critères
Inclusion Criteria Patients may be eligible for this study if they: * Are HIV-positive. * Are at least 18 years old. * Have a CD4 count less than or equal to 500 cells/mm3 and an HIV RNA level greater than or equal to 5000 copies/ml. * Are about to start a regimen of at least 3 anti-HIV drugs (HAART). Exclusion Criteria Patients will not be eligible for this study if they: * Have ever received protease inhibitors (PIs) or nonnucleoside reverse transcriptase inhibitors (NNRTIs). * Have had signs or symptoms of lung disease in the past 30 days (pneumonia, bronchitis, emphysema, asthma, severe cough, or severe shortness of breath). * Have received certain medications, including HIV vaccines. * Have received chemotherapy within 30 days prior to study entry, or have cancer that will require chemotherapy. * Are pregnant and will be beyond the first 3 months of pregnancy by Week 24 (Month 6) of the study.
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 5 sites
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, United StatesOuvrir Indiana Univ. School of Medicine, Infectious Disease Research Clinic dans Google MapsNY Univ. HIV/AIDS CRS
New York, United StatesUniv. of Cincinnati CRS
Cincinnati, United StatesHosp. of the Univ. of Pennsylvania CRS
Philadelphia, United States