Effect of Highly Active Antiretroviral Therapy (HAART) on Viral Burden and Immune Function in the Lungs of HIV-Infected Subjects
Data Collection
Blood-Borne Infections+17
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
Study start date: August 1, 1999
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.50 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 5 locations
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, United StatesOpen Indiana Univ. School of Medicine, Infectious Disease Research Clinic in 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