Clinical Trials

MainTitle

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

This study has been completed
Sponsor
UPECLIN HC FM Botucatu Unesp


Information provided by (Responsible Party)
UPECLIN HC FM Botucatu Unesp
ClinicalTrials.gov Identifier
NCT00516581

First received: August 14, 2007
Last updated: September 4, 2008
Last Verified: September 2008
History of Changes
Purpose

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

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

Enrollment: 376
Study Start Date: February 2003
Study Completion Date: February 2005

Arms
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

Eligibility

Ages Eligible for Study: 18 Years to 70 Years  
Sexes Eligible for Study: All  
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

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

More Information


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  

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

ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.