Assessing the prevalence of pulmonary function testing abnormalities in HIV-infected patients with and without a history of PJP.
ID
Source
Brief title
Condition
- Protozoal infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The prevalence of abnormalities in pulmonary function testing like obstructive
or restrictive lung disease and CO diffusion impairment. The following
parameters will be assessed: Vital capacity, Forced Expiratory Volume in 1
second (FEV1) and carbon-dioxide diffusion capacity.
Secondary outcome
1. to establish if the prevalence of obstructive ventilatory disorder in HIV
infected patients with a history of PJP is significantly higher than in the HIV
positive matched controls;
2. to establish if the prevalence of restrictive ventilatory disorder in HIV
infected patients with a history of PJP is significantly higher than in the HIV
positive matched controls;
3. to establish if there is relation between diminishing of de pulmonary
diffusion capacity and the self-reported pulmonary complaints;
4. to establish if the self-reported pulmonary complaints are more prevalent in
the group of HIV patients with history of PJP compared to matched controls.
Background summary
In the early years of the HIV-epidemic, Pneumocystis jirovecii pneumonia (PJP)
was one of the leading causes of morbidity and mortality in HIV-infected
patients. One of the most significant features of PJP is the severe impairment
of the pulmonary diffusion capacity, which was also used to establish the
diagnosis. The introduction of effective combined antiretroviral therapy (cART)
has led to a dramatic improvement in the survival of HIV-infected patients with
opportunistic infections, and also of those with PJP. However, it is unclear
whether the diffusion capacity completely resolves after completing of the
antimicrobial therapy directed against Pneumocystis.
In the University Medical Centre Utrecht, approximately 50 HIV-positive
patients with a history of PJP underwent pulmonary function testing as a matter
of routine care. The presence of persistent impaired diffusion capacity was
frequently encountered in these patients. However, it is unclear what the
background prevalence of diffusion impairment in the general HIV-positive
population in the Netherlands is. In order to draw conclusions from the earlier
observations, we are planning to set-up a cohort of HIV-positive controls
without a history of PJP that are matched by age, gender, nadir CD4 cell count,
time since HIV diagnosis and smoking history with the historical cohort.
Patients from the historical cohort will be approached to give consent for the
use of the earlier data.
Study objective
Assessing the prevalence of pulmonary function testing abnormalities in
HIV-infected patients with and without a history of PJP.
Study design
Observational cohort study
Study burden and risks
Patients without a history of PJP: The burden of research for these patients is
very limited. The study consists of two parts. First, the patient is contacted
twice by phone: the first phone call to explain the study, after which the
patient (after consenting) is sent information pertaining to the study to his
home address. The second phone call will be made after two weeks in order to
answer remaining questions about the study and to ask whether the patient wants
to participate (in which case he will sign and return the sent informed consent
forms). Second, the patient will undergo pulmonary function testing - which
takes approximately 40 minutes. There are no health or safety risks related to
the pulmonary function testing.
Only the group without history of PJP will undergo a pulmonary function
testing. In the group of patients with history of PJP, the results of the
routinely performed pulmonary function tests will be used. These patients will
also be called twice for recruitment and consent, via the same procedure as
described above.
With respect to the patients who already underwent pulmonary function testing,
the burden is also limited. They will only be approached for consent to use the
data of the earlier pulmonary function tests.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
HIV-infected patients with and without a history of Pneumocystis Jirovecii
Pneumonia
Exclusion criteria
* Active pulmonary infection or cardiac decompensation at the moment of
pulmonary function testing
* Chronic condition which could influence the pulmonary function testing
* Unexplained dyspnoea, tachypnoea or other acute respiratory complaints at the
moment of pulmonary function testing (<3 weeks of duration)
* In the opinion of treating physician, not being able to cooperate during the
pulmonary function testing.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL62009.041.20 |