PneumocystisNCT03856229
Short-term Steroid Therapy in Patients With P. Jirovecii Pneumonia Due to HIV / AIDS
A study testing Conventional steroid regimen and Shortened steroid regimen in people with Pneumocystis and HIV/AIDS, run by Centro de Investigación en. Enfermedades Infecciosas, Mexico at 1 site in Mexico.
Trial summary
The treatment guidelines for Pneumocystis pneumonia (PCP) suggest adding 40mg of prednisone (or its equivalent in methylprednisolone) twice per day on days 1 through 5, 40 mg days 6 through 10, and 20 mg daily on days 11 through 21 in subjects with moderate and serious PCP. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pneumocystis, HIV/AIDS, Steroid
- What is being tested?
- Conventional steroid regimen and Shortened steroid regimen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteMexico
- Study dates
- 4 Mar 2019to 30 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older than 18 years
- To have a gasometry at the admission that confirms moderate or severe PCP.
- Patients receiving trimethoprim / sulfamethoxazole in doses of 15 to 20 mg / kg per day from the first 24 hours after admission.
- Patients who have begun adjuvant treatment with steroids in the first 48 hours after admission.
- No history of chronic pulmonary disease.
- APACHE at hospitalization less than 20 points.
Who cannot join
- Allergic to TMP/SMX, who have not tolerated desensitization.
- History of inflammatory, infectious, autoimmune or neoplastic diseases except Kaposi's sarcoma, which merit the chronic use of steroids.
- Pleural or pericardial effusion and meningitis from any cause.
- Septic shock not related to PCP.
- Subjects who during the hospitalization have been diagnosed with any neoplasia (except Kaposi´s sarcoma)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site
Centro de Investigacion en Enfermedades Infecciosas
México, State of Mexico, 14080
About this study
Official title: Shortened Steroid Therapy in Patients With Moderate and Severe Pneumonia Due to P. Jirovecii Associated With HIV / AIDS
The treatment guidelines for Pneumocystis pneumonia (PCP) suggest adding 40mg of prednisone (or its equivalent in methylprednisolone) twice per day on days 1 through 5, 40 mg days 6 through 10, and 20 mg daily on days 11 through 21 in subjects with moderate and serious PCP. Steroids have shown to improve clinical outcome and reduction in mortality in HIV-infected patients the effectiveness of adjuvant steroid treatment for PCP has been observed if it starts within the first 24 to 48 hours. Possibly, there is a long-term benefit with their use in the recovery of function and limitation of chronic pulmonary complications; recently, benefits have been observed in decreasing the incidence of Inflammatory Immune Reconstitution Syndrome (IRIS) due to Mycobacterium tuberculosis. On the other hand, steroids could increase the morbidity related to adverse reactions as well as paradoxical worsening of associated herpes virus infection, which are attributed to IRIS or as a result of immunosuppression generated by their use. Recently, it has been shown that gradually steroids withdrawal is not necessary in patients who have received less than 21 days of treatment.
This non-inferiority work aims to confirm the null hypothesis that a reduced steroid scheme in patients with moderate PCP (8 days) and severe pneumonia (14 days) is sufficient to limit long-term ventilatory complications and acute postinflammatory syndrome, compared to the conventional 21-day scheme. It also has been hypothesized that it could be associated with fewer cases of IRIS due to herpes virus type 1,2,3 and 8.
Read the detailed description
The investigators selected hospitalized subjects with confirmed or suspected moderate or severe PCP: the diagnostic certainty will be based on the following criteria:
Proved PCP. Defined as cases with presence of P. jirovecii cysts in bronchial alveolar lavage (BAL) exams or lung biopsy.
Possible PCP. Defined by the following two criteria: 1) the presence of three of four items: cough, fever, dyspnea and compatible radiological or tomographic findings 2) associated clinical improvement after the onset of trimethoprim/sulfamethoxazole (TMP / SMX).
Probable PCP. Defined as the presence of one of the two previous criteria, without other identified microorganisms.
The radiological or tomographic findings compatible with PCP are: presence of bilateral reticular infiltrate, ground glass, crazy paving pattern and presence of bullae, cysts or spontaneous pneumothorax.
The microbiological findings will be the identification of cysts in the Grocott stain or a positive immunofluorescence test (IFA).
Patients will be classified as moderate PCP when the partial pressure of oxygen (PaO2) is less than 70 mmHg and the alveolar arterial difference (Da-a) is greater than 35 mmHg and severe PCP when it is greater than 45 mmHg.
The sample size was calculated for non-inferiority tests to a tail with an estimated mortality of 16% for both groups; using a Z alpha in 1.65 and Z beta in 1.645, with a non-inferiority margin of 0.6; resulting in 98 subjects per group.
After obtaining the informed consent, patients will be randomized accordingly to their CD4+ T cell count (less or more than 50 cells/mm3 and assigned to each group:
- Group A or Conventional Steroids use (CoSt).patients will receive 21 days of steroid treatment.
- Group B or Shortened Steroids use (SSt). Subjects with moderate PCP will receive 8 days of steroids and subjects with severe PCP 14 days of steroids.
The equivalent prednisone doses of systemic steroids will be recorded, as well as the duration of their administration since it could be modified according to the criteria of the treating physicians; demographic data, the start date of ART (Antiretroviral Therapy), and the presence of other opportunistic, nosocomial and co-infections will also be recorded.
The laboratory data that will be recorded at the time of diagnostic suspicion of PCP will be: CD4+ T cell count, HIV viral load, lactate dehydrogenase (LDH), C-reactive protein (PCRe), pAO2, Da-aO2.
Once the patient has been discharged, the patient will be scheduled to continue ambulatory, conventional follow-up at 90, 180 and 360 days after starting the ART and to evaluate secondary outcomes.
Once 50% of the sample size has completed 30 days of follow-up, a preliminary analysis will be conducted to assess safety and efficacy; if differences in the mortality are observed, the study will be terminated.
- Conditions
- Pneumocystis, HIV/AIDS, Steroid
- Being tested
- Conventional steroid regimen, Shortened steroid regimen
- Keywords
- HIV/AIDS, PCP treatment, Steroids for PCP
- 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.
Conventional steroid regimenDrug
Also called CoSt
Subjects will receive the conventional steroid regimen with prednisolone or equivalent (with methylprednisolone): Day 1 to 5: 40 mg orally every 12 h; Day 6 to 10: 40 orally every 24 hours; and Day 11 to 21: 20 mg orally every 24 h.
Shortened steroid regimenDrug
Also called SSt
- Subjects with Moderate PCP. Prednisolone (or equivalent with methylprednisolone) 40 mg orally every 12 h (Day 1 to 5);40 mg orally every 24 hours (Day 6 to 8).
- Subjects with severe PCP. Prednisolone (or equivalent with methylprednisolone) 40 mg orally every 12 h (Day 1 to 5),40 mg orally every 24 hours (Day 6 to 10); and 20 mg orally every 24 h (Day 11 to 14).
| Study group | Role | What they receive |
|---|---|---|
| Group A conventional steroid regimen | Active comparator | Subjects will receive the conventional steroid regimen with prednisolone or equivalent (with methylprednisolone): Day 1 to 5: 40 mg orally every 12 h; Day 6 to 10: 40 orally every 24 hours; and Day 11 to 21: 20 mg orally every 24 h. Receives: Drug: Conventional steroid regimen |
| Group B shortened steroid regimen | Experimental | Subjects will receive the shortened steroid regimen for the severity of pneumonia with prednisone or equivalent with methylprednisolone, depending the severity of pneumonia:
* Moderate PCP. 40 mg orally every 12 h (Day 1 to 5);40 mg orally every 24 hours (Day 6 to 8).
* Severe PCP. 40 mg orally every 12 h (Day 1 to 5),40 mg orally every 24 hours (Day 6 to 10); and 20 mg orally every 24 h (Day 11 to 14). Receives: Drug: Shortened steroid regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of Mortality at 30 days
To compare 30-day cumulative incidence of mortality in subjects with moderate and severe PCP and HIV infection in patients receiving the shortened steroid scheme or the conventional 21-day schedule.
Measured: 30 days
Secondary outcomes (24)
Cumulative incidence of Mortality at 90 days
To compare cumulative incidence of mortality in patients receiving the shortened steroid scheme or the conventional 21-day schedule, at 90 days
Measured: 90 days
Cumulative incidence of mortality at 360 days
To compare mortality in patients receiving the shortened steroid scheme or the conventional 21-day schedule
Measured: 360 days
Cumulative incidence of mortality by CMV pneumonitis
To compare cumulative incidence of mortality stratified by the CMV pneumonitis (yes or not) in patients receiving the shortened steroid scheme or the conventional 21-day schedule, at 360 days
Measured: 360 days
Cumulative incidence of mortality by CD4+T cell count
To compare cumulative incidence of mortality stratified by the CD4+ T cell count (less of or more than 50 cells per mm3), in patients receiving the shortened steroid scheme or the conventional 21-day schedule
Measured: 360 days
Cumulative incidence of mortality by PCP severity
To compare cumulative incidence of mortality stratified by the PCP severity (moderate or severe), according with the gasometric parameters (AIDSinfo), in patients receiving the shortened steroid scheme or the conventional 21-day schedule
Measured: 360 days
Time of intubation
To compare the time of intubation expressed in days of intubation,in subjects receiving the shortened steroid scheme or the conventional 21-day schedule
Measured: 90 days
Time of intubation stratified by PCP severity
To compare the time of intubation expressed in days of intubation, in patients receiving the shortened and conventional steroid scheme, stratified by the PCP severity (moderate or severe), according with the gasometric parameters (AIDSinfo)
Measured: 90 days
Number of participants with ventilatory requirements, stratified by the CD4+ T cell count
To compare the ventilatory requirements expressed by need for reintubation or intubation during hospitalization, in patients receiving the shortened and conventional steroid scheme, stratified by the CD4+ T cell count (less or more than 50 cells per mm3).
Measured: 90 days
Number of participants with ventilatory requirements stratified by the CMV coinfection
To compare the ventilatory requirements, expressed by need for reintubation, in patients receiving the shortened and conventional steroid scheme, stratified by the CMV coinfection (yes or not)
Measured: 90 days
Media of arterial oxygenation
To compare the arterial oxygenation thresholds using the media of arterial partial pressure of oxygen (PaO2) in arterial blood gasometry, obtained at admission, and 21 days in subjects receiving the shortened and conventional steroid scheme
Measured: 90 days
Media of arterial oxygenation, stratified by PCP severity
To compare the arterial oxygenation thresholds using the media of arterial partial pressure of oxygen (PaO2) in arterial blood gasometry, obtained at admission, and 21 days in subjects receiving the shortened and conventional steroid scheme, stratified by the PCP severity (moderate or severe)
Measured: 90 days
Media of arterial oxygenation, stratified by CD4+ T cell Count
To compare the arterial oxygenation thresholds using the media of arterial partial pressure of oxygen (PaO2) in arterial blood gasometry, obtained at admission, and 21 days in subjects receiving the shortened and conventional steroid scheme, stratified by the CD4+ T cell count (less or more than 50 cells per mm3)
Measured: 90 days
Media of arterial oxygenation, stratified by the CMV pneumonitis
To compare the arterial oxygenation thresholds using the media of arterial partial pressure of oxygen (PaO2) in arterial blood gasometry, obtained at admission, and 21 days in subjects receiving the shortened and conventional steroid scheme, stratified by the presence or absence of CMV pneumonitis
Measured: 90 days
Pulmonary function
To compare the pulmonary function, expressed by the spirometric pattern (normal, or obstructive, or restrictive), in pre and post-bronchodilator spirometry at 360 days in patients receiving the shortened and conventional steroid scheme.
Measured: 360 days
Pulmonary function changes
To compare the changes in the spirometry pattern (normal, or obstructive, or restrictive), between baseline and 360 days in subjects receiving the shortened and conventional steroid scheme.
Measured: 360 days
Pulmonary function by spirometry, stratified by CD4+ T cell count
To compare the pulmonary function, expressed by the spirometric pattern (normal, or obstructive, or restrictive), in pre and post-bronchodilator spirometry, in patients receiving the shortened and conventional steroid scheme, stratified by the CD4+ T cell count (less or more than 50 cells per mm3)
Measured: 360 days
Pulmonary function by spirometry, stratified by PCP severity
To compare the pulmonary function, expressed by the spirometric pattern (normal, or obstructive, or restrictive), in pre and post-bronchodilator spirometry, in patients receiving the shortened and conventional steroid scheme, stratified by the PCP severity (moderate or severe)
Measured: 360 days
Pulmonary function by spirometry, stratified by CMV pneumonitis
To compare the pulmonary function, expressed by the spirometric pattern (normal, or obstructive, or restrictive), in pre and post-bronchodilator spirometry, in patients receiving the shortened and conventional steroid scheme, stratified by the presence or absence of CMV pneumonitis
Measured: 360 days
Changes in diffusing lung capacity of carbon monoxide
To compare the changes in the diffusing lung capacity of carbon monoxide (DLCO) in patients receiving the shortened and conventional steroid scheme
Measured: 360 days
Changes in diffusing lung capacity of carbon monoxide by CMV coinfection
To compare the changes in the diffusing lung capacity of carbon monoxide (DLCO) in patients receiving the shortened and conventional steroid scheme, stratified by the CMV coinfection
Measured: 360 days
Changes in diffusing lung capacity of carbon monoxide by the PCP severity
To compare the changes in the diffusing lung capacity of carbon monoxide (DLCO) in patients receiving the shortened and conventional steroid scheme, stratified by the PCP severity
Measured: 360 days
Changes in diffusing lung capacity of carbon monoxide by CD4+ cell count
To compare the changes in the diffusing lung capacity of carbon monoxide (DLCO) in patients receiving the shortened and conventional steroid scheme, stratified by the CD4+ T cell count less or more than 50 cells per mm3
Measured: 360 days
IRIS
Compare the cumulative incidence of IRIS associated with herpes virus infection 1, 2, 3, and 8, in patients receiving the shortened and conventional steroid scheme
Measured: 360 days
Herpes virus dynamic
Measure the replication of herpes virus with the plasma viral load of Epstein-Barr Virus (EBV), Cytomegalovirus (CMV) and human herpes-virus 8 (HHV8) in blood
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start4 Mar 2019
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumocystisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After obtaining the informed consent. The subjects will be randomized 6 days after starting treatment for PCP with trimethoprim/ sulfamethoxazole plus prednisone or methylprednisolone. Stratified randomization will be generated by an electronic system, in blocks of 6 and 8, and a 1:1 ratio, according to the CD4+ T cell count (less or more than 50 cells/mm3 and assigned to each group: * Group A or Conventional Steroids use (CoSt). Patients will receive 21 days of steroid treatment. * Group B or Shortened Steroids use (SSt). Subjects with moderate PCP will receive 8 days of steroids and subjects with severe PCP 14 days of steroids.
- Masking
- None (open label)
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro de Investigación en. Enfermedades Infecciosas, Mexico
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gustavo Reyes-Teran, Centro de Investigación en. Enfermedades Infecciosas, Mexico
- Investigators
- Gustavo Reyes-Teran, M.D., Principal investigator, Instituto Nacional de Enfermedades Respiratorias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03856229
- Sponsor's protocol ID
- C40-18
- Status last verified
- Mar 2026
- First submitted
- 8 Feb 2019
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shortened Steroid Therapy in Patients With Moderate and Severe Pneumonia Due to P. Jirovecii Associated With HIV / AIDS
- ClinicalTrials.gov ID
- NCT03856229
- Acronym / sponsor ID
- C40-18
- Conditions
- Pneumocystis, HIV/AIDS, Steroid
- Keywords
- HIV/AIDS, PCP treatment, Steroids for PCP
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Centro de Investigación en. Enfermedades Infecciosas, MexicoOther government
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 27 Feb 2019 (actual)
- 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.
The treatment guidelines for Pneumocystis pneumonia (PCP) suggest adding 40mg of prednisone (or its equivalent in methylprednisolone) twice per day on days 1 through 5, 40 mg days 6 through 10, and 20 mg daily on days 11 through 21 in subjects with moderate and serious PCP. Steroids have shown to improve clinical outcome and reduction in mortality in HIV-infected patients the effectiveness of adjuvant steroid treatment for PCP has been observed if it starts within the first 24 to 48 hours. Possibly, there is a long-term benefit with their use in the recovery of function and limitation of chronic pulmonary complications; recently, benefits have been observed in decreasing the incidence of Inflammatory Immune Reconstitution Syndrome (IRIS) due to Mycobacterium tuberculosis. On the other hand, steroids could increase the morbidity related to adverse reactions as well as paradoxical worsening of associated herpes virus infection, which are attributed to IRIS or as a result of immunosuppression generated by their use. Recently, it has been shown that gradually steroids withdrawal is not necessary in patients who have received less than 21 days of treatment.
This non-inferiority work aims to confirm the null hypothesis that a reduced steroid scheme in patients with moderate PCP (8 days) and severe pneumonia (14 days) is sufficient to limit long-term ventilatory complications and acute postinflammatory syndrome, compared to the conventional 21-day scheme. It also has been hypothesized that it could be associated with fewer cases of IRIS due to herpes virus type 1,2,3 and 8.
Detailed description
The investigators selected hospitalized subjects with confirmed or suspected moderate or severe PCP: the diagnostic certainty will be based on the following criteria:
Proved PCP. Defined as cases with presence of P. jirovecii cysts in bronchial alveolar lavage (BAL) exams or lung biopsy.
Possible PCP. Defined by the following two criteria: 1) the presence of three of four items: cough, fever, dyspnea and compatible radiological or tomographic findings 2) associated clinical improvement after the onset of trimethoprim/sulfamethoxazole (TMP / SMX).
Probable PCP. Defined as the presence of one of the two previous criteria, without other identified microorganisms.
The radiological or tomographic findings compatible with PCP are: presence of bilateral reticular infiltrate, ground glass, crazy paving pattern and presence of bullae, cysts or spontaneous pneumothorax.
The microbiological findings will be the identification of cysts in the Grocott stain or a positive immunofluorescence test (IFA).
Patients will be classified as moderate PCP when the partial pressure of oxygen (PaO2) is less than 70 mmHg and the alveolar arterial difference (Da-a) is greater than 35 mmHg and severe PCP when it is greater than 45 mmHg.
The sample size was calculated for non-inferiority tests to a tail with an estimated mortality of 16% for both groups; using a Z alpha in 1.65 and Z beta in 1.645, with a non-inferiority margin of 0.6; resulting in 98 subjects per group.
After obtaining the informed consent, patients will be randomized accordingly to their CD4+ T cell count (less or more than 50 cells/mm3 and assigned to each group:
- Group A or Conventional Steroids use (CoSt).patients will receive 21 days of steroid treatment.
- Group B or Shortened Steroids use (SSt). Subjects with moderate PCP will receive 8 days of steroids and subjects with severe PCP 14 days of steroids.
The equivalent prednisone doses of systemic steroids will be recorded, as well as the duration of their administration since it could be modified according to the criteria of the treating physicians; demographic data, the start date of ART (Antiretroviral Therapy), and the presence of other opportunistic, nosocomial and co-infections will also be recorded.
The laboratory data that will be recorded at the time of diagnostic suspicion of PCP will be: CD4+ T cell count, HIV viral load, lactate dehydrogenase (LDH), C-reactive protein (PCRe), pAO2, Da-aO2.
Once the patient has been discharged, the patient will be scheduled to continue ambulatory, conventional follow-up at 90, 180 and 360 days after starting the ART and to evaluate secondary outcomes.
Once 50% of the sample size has completed 30 days of follow-up, a preliminary analysis will be conducted to assess safety and efficacy; if differences in the mortality are observed, the study will be terminated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- After obtaining the informed consent. The subjects will be randomized 6 days after starting treatment for PCP with trimethoprim/ sulfamethoxazole plus prednisone or methylprednisolone. Stratified randomization will be generated by an electronic system, in blocks of 6 and 8, and a 1:1 ratio, according to the CD4+ T cell count (less or more than 50 cells/mm3 and assigned to each group: * Group A or Conventional Steroids use (CoSt). Patients will receive 21 days of steroid treatment. * Group B or Shortened Steroids use (SSt). Subjects with moderate PCP will receive 8 days of steroids and subjects with severe PCP 14 days of steroids.
| Arm | Type | Receives |
|---|---|---|
| Group A conventional steroid regimen | Active comparator | Drug: Conventional steroid regimenSubjects will receive the conventional steroid regimen with prednisolone or equivalent (with methylprednisolone): Day 1 to 5: 40 mg orally every 12 h; Day 6 to 10: 40 orally every 24 hours; and Day 11 to 21: 20 mg orally every 24 h. |
| Group B shortened steroid regimen | Experimental | Drug: Shortened steroid regimenSubjects will receive the shortened steroid regimen for the severity of pneumonia with prednisone or equivalent with methylprednisolone, depending the severity of pneumonia: * Moderate PCP. 40 mg orally every 12 h (Day 1 to 5);40 mg orally every 24 hours (Day 6 to 8). * Severe PCP. 40 mg orally every 12 h (Day 1 to 5),40 mg orally every 24 hours (Day 6 to 10); and 20 mg orally every 24 h (Day 11 to 14). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Older than 18 years
- To have a gasometry at the admission that confirms moderate or severe PCP.
- Patients receiving trimethoprim / sulfamethoxazole in doses of 15 to 20 mg / kg per day from the first 24 hours after admission.
- Patients who have begun adjuvant treatment with steroids in the first 48 hours after admission.
- No history of chronic pulmonary disease.
Key exclusion criteria (5 listed)
- Allergic to TMP/SMX, who have not tolerated desensitization.
- History of inflammatory, infectious, autoimmune or neoplastic diseases except Kaposi's sarcoma, which merit the chronic use of steroids.
- Pleural or pericardial effusion and meningitis from any cause.
- Septic shock not related to PCP.
- Subjects who during the hospitalization have been diagnosed with any neoplasia (except Kaposi´s sarcoma)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional steroid regimenAlso: CoStSubjects will receive the conventional steroid regimen with prednisolone or equivalent (with methylprednisolone): Day 1 to 5: 40 mg orally every 12 h; Day 6 to 10: 40 orally every 24 hours; and Day 11 to 21: 20 mg orally every 24 h. | Drug | Group A conventional steroid regimen |
| Shortened steroid regimenAlso: SSt* Subjects with Moderate PCP. Prednisolone (or equivalent with methylprednisolone) 40 mg orally every 12 h (Day 1 to 5);40 mg orally every 24 hours (Day 6 to 8). * Subjects with severe PCP. Prednisolone (or equivalent with methylprednisolone) 40 mg orally every 12 h (Day 1 to 5),40 mg orally every 24 hours (Day 6 to 10); and 20 mg orally every 24 h (Day 11 to 14). | Drug | Group B shortened steroid regimen |
Primary outcome
Cumulative incidence of Mortality at 30 days
Time frame: 30 days
To compare 30-day cumulative incidence of mortality in subjects with moderate and severe PCP and HIV infection in patients receiving the shortened steroid scheme or the conventional 21-day schedule.
24 secondary outcomes
Cumulative incidence of Mortality at 90 days
Time frame: 90 days
Cumulative incidence of mortality at 360 days
Time frame: 360 days
Cumulative incidence of mortality by CMV pneumonitis
Time frame: 360 days
Cumulative incidence of mortality by CD4+T cell count
Time frame: 360 days
Cumulative incidence of mortality by PCP severity
Time frame: 360 days
Time of intubation
Time frame: 90 days
Time of intubation stratified by PCP severity
Time frame: 90 days
Number of participants with ventilatory requirements, stratified by the CD4+ T cell count
Time frame: 90 days
Number of participants with ventilatory requirements stratified by the CMV coinfection
Time frame: 90 days
Media of arterial oxygenation
Time frame: 90 days
Media of arterial oxygenation, stratified by PCP severity
Time frame: 90 days
Media of arterial oxygenation, stratified by CD4+ T cell Count
Time frame: 90 days
Media of arterial oxygenation, stratified by the CMV pneumonitis
Time frame: 90 days
Pulmonary function
Time frame: 360 days
Pulmonary function changes
Time frame: 360 days
Pulmonary function by spirometry, stratified by CD4+ T cell count
Time frame: 360 days
Pulmonary function by spirometry, stratified by PCP severity
Time frame: 360 days
Pulmonary function by spirometry, stratified by CMV pneumonitis
Time frame: 360 days
Changes in diffusing lung capacity of carbon monoxide
Time frame: 360 days
Changes in diffusing lung capacity of carbon monoxide by CMV coinfection
Time frame: 360 days
Changes in diffusing lung capacity of carbon monoxide by the PCP severity
Time frame: 360 days
Changes in diffusing lung capacity of carbon monoxide by CD4+ cell count
Time frame: 360 days
IRIS
Time frame: 360 days
Herpes virus dynamic
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Gustavo Reyes-Teran, M.D. principal investigator
Instituto Nacional de Enfermedades Respiratorias
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional steroid regimen and Shortened steroid regimen in people with Pneumocystis and HIV/AIDS, run by Centro de Investigación en. Enfermedades Infecciosas, Mexico at 1 site in Mexico.
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 6 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 27 Mar 2026. 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 Mexico. 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?
This study is still under way. Results are not available in the source record yet.
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.
What does the primary outcome measure?
Cumulative incidence of Mortality at 30 days (time frame: 30 days). It is what the study was designed to measure, not a finding.
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 27 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.