HIVNCT00516581
Occurrence of Pneumocystis Pneumonia in HIV-Infected Patients and the Interference of the HAART
An observational study of HIV, run by UPECLIN HC FM Botucatu Unesp at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- HIV
- How many people
- 376 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2003to Feb 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 376 HIV-infected or AIDS patients were studied from January 1992 to December 2002
Who may be able to join
- HIV infection
Who cannot join
- No HIV infection
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Faculdade de Medicina de Botucatu - Unesp
Botucatu, São Paulo, 18618970
About this study
Official title: 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.
Read the 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
- Keywords
- Pneumocystis Pneumonia, Acquired Immune Deficiency Syndrome, Highly Active Antiretroviral Therapy, Treatment Experienced, Treatment Naive
- Medical subject headings
- Pneumonia, Pneumocystis, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| no HAART | Patients that no received HAART | |
| with HAART | Patients that received HAART |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2007 (estimated)
- Study startFeb 2003
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 376 participants (actual)
Sponsor and investigators
- Lead sponsor
- UPECLIN HC FM Botucatu Unesp
- Sponsor type
- University, hospital or other
- Investigators
- Alexandre N Barbosa, MD, MSc, Principal investigator, UPECLIN HC FM Botucatu Unesp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00516581
- Sponsor's protocol ID
- upeclin/HC/FMB-Unesp-13
- Other IDs
- PCP UnespFMB 2003
- Status last verified
- Sep 2008
- First submitted
- 14 Aug 2007
- Last updated
- 5 Sep 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occurrence of Pneumocystis Pneumonia in HIV-Infected Patients and the Interference of the Highly Active Antiretroviral Therapy
- ClinicalTrials.gov ID
- NCT00516581
- Acronym / sponsor ID
- upeclin/HC/FMB-Unesp-13
- Conditions
- HIV
- Keywords
- Pneumocystis Pneumonia, Acquired Immune Deficiency Syndrome, Highly Active Antiretroviral Therapy, Treatment Experienced, Treatment Naive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 376 participants (actual)
- Lead sponsor
- UPECLIN HC FM Botucatu UnespUniversity, hospital or other
- Study start
- Feb 2003
- Study completion
- Feb 2005 (actual)
- First posted
- 15 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| no HAART | – | –Patients that no received HAART |
| with HAART | – | –Patients that received HAART |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 376 HIV-infected or AIDS patients were studied from January 1992 to December 2002
Key inclusion criteria (1 listed)
- HIV infection
Key exclusion criteria (1 listed)
- No HIV infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandre N Barbosa, MD, MSc principal investigator
UPECLIN HC FM Botucatu Unesp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by UPECLIN HC FM Botucatu Unesp at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2008.