- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00516581
Occurrence of Pneumocystis Pneumonia in HIV-Infected Patients and the Interference of the HAART
September 4, 2008 updated by: UPECLIN HC FM Botucatu Unesp
Occurrence of Pneumocystis Pneumonia in HIV-Infected Patients and the Interference of the Highly Active Antiretroviral Therapy
From the beginning of the AIDS epidemic, pulmonary pneumocystosis (PCP) has been distinguished as one of the most frequent opportunistic diseases with high morbid-mortality.
As from 1996, the advent of the highly active antiretroviral therapy (HAART) has changed the characteristics of such epidemic by reducing its related diseases and, as a result, AIDS-related mortality.
With the purpose to estimate PCP occurrence and HAART interference, 376 HIV-infected or AIDS patients were studied from January 1992 to December 2002.
Study Overview
Status
Completed
Conditions
Detailed Description
From the beginning of the AIDS epidemic, pneumocystis pneumonia (PCP) has been distinguished as one of the most frequent opportunistic diseases with high morbid-mortality.
As from 1996, the advent of the highly active antiretroviral therapy (HAART) has changed the characteristics of such epidemic by reducing its related diseases and, as a result, AIDS-related mortality.
With the purpose to estimate PCP occurrence and HAART interference, 376 HIV-infected or AIDS patients were studied from January 1992 to December 2002.
Among them, 58 (15.5%)
PCP cases were found.
There was a higher occurrence of PCP in the group of patients in which HAART was not used, with 40 (69.0%) of the episodes.
As regards the studied period, a tendency to a linear reduction in annual PCP incidence was observed.
The mean of T CD4+ lymphocytes in the patients with PCP (117 cells/mm3) was significantly lower when compared to that of the other individuals (325 cells/mm3).
Therefore, this study suggests a temporal reduction in PCP occurrence related to HAART use with higher T CD4+ lymphocyte counts.
Nevertheless, this opportunistic infection still shows significant incidence in AIDS patients.
Study Type
Observational
Enrollment (Actual)
376
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Sao Paulo
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Botucatu, Sao Paulo, Brazil, 18618970
- Faculdade de Medicina de Botucatu - UNESP
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
376 HIV-infected or AIDS patients were studied from January 1992 to December 2002
Description
Inclusion Criteria:
- HIV infection
Exclusion Criteria:
- No HIV infection
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
no HAART
Patients that no received HAART
|
with HAART
Patients that received HAART
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2003
Study Completion (Actual)
February 1, 2005
Study Registration Dates
First Submitted
August 14, 2007
First Submitted That Met QC Criteria
August 14, 2007
First Posted (Estimate)
August 15, 2007
Study Record Updates
Last Update Posted (Estimate)
September 5, 2008
Last Update Submitted That Met QC Criteria
September 4, 2008
Last Verified
September 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- upeclin/HC/FMB-Unesp-13
- PCP UnespFMB 2003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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