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

NCT ID: NCT00516581

Last Updated: 2008-09-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 376 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2003-02-28
• Study Completion Date: 2005-02-28

Brief Summary

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.

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.

Conditions

HIV

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

no HAART

Patients that no received HAART

No interventions assigned to this group

with HAART

Patients that received HAART

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• HIV infection

Exclusion Criteria

• No HIV infection

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UPECLIN HC FM Botucatu Unesp

OTHER

Sponsor Role: lead

Responsible Party

Faculdade de Medicina de Botucatu - Unesp

Principal Investigators

Alexandre N Barbosa, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

UPECLIN HC FM Botucatu Unesp

Locations

Faculdade de Medicina de Botucatu - Unesp

Botucatu, São Paulo, Brazil

Countries

Brazil

Other Identifiers

PCP UnespFMB 2003

Identifier Type: -

Identifier Source: secondary_id

upeclin/HC/FMB-Unesp-13

Identifier Type: -

Identifier Source: org_study_id