Occurrence of Pneumocystis Pneumonia in HIV-Infected Patients and the Interference of the HAART

This study has been completed.
Sponsor:
Information provided by:
UPECLIN HC FM Botucatu Unesp
ClinicalTrials.gov Identifier:
NCT00516581
First received: August 14, 2007
Last updated: September 4, 2008
Last verified: September 2008
  Purpose

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.


Condition Phase
HIV
Phase 3

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Occurrence of Pneumocystis Pneumonia in HIV-Infected Patients and the Interference of the Highly Active Antiretroviral Therapy

Resource links provided by NLM:


Further study details as provided by UPECLIN HC FM Botucatu Unesp:

Enrollment: 376
Study Start Date: February 2003
Study Completion Date: February 2005
Groups/Cohorts
no HAART
Patients that no received HAART
with HAART
Patients that received HAART

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

376 HIV-infected or AIDS patients were studied from January 1992 to December 2002

Criteria

Inclusion Criteria:

  • HIV infection

Exclusion Criteria:

  • No HIV infection
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00516581

Locations
Brazil
Faculdade de Medicina de Botucatu - Unesp
Botucatu, Sao Paulo, Brazil, 18618970
Sponsors and Collaborators
UPECLIN HC FM Botucatu Unesp
Investigators
Principal Investigator: Alexandre N Barbosa, MD, MSc UPECLIN HC FM Botucatu Unesp
  More Information

No publications provided

Responsible Party: Sergio Muller, Faculdade de Medicina de Botucatu - Unesp
ClinicalTrials.gov Identifier: NCT00516581     History of Changes
Other Study ID Numbers: upeclin/HC/FMB-Unesp-13, PCP UnespFMB 2003
Study First Received: August 14, 2007
Last Updated: September 4, 2008
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by UPECLIN HC FM Botucatu Unesp:
Pneumocystis Pneumonia
Acquired Immune Deficiency Syndrome
Highly Active Antiretroviral Therapy
Treatment Experienced
Treatment Naive

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Pneumocystis
Lung Diseases
Lung Diseases, Fungal
Mycoses
Pneumocystis Infections
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on October 22, 2014