Immune Reconstitution Inflammatory Syndrome

National Institutes of Health Clinical Center, 9000 Rockville Pike

The Thai Red Cross AID Research Center (TRC-ARC)

Bamrasnaradura Infectious Disease Institute (BIDI)

Immune Reconstitution Syndrome in HIV-Infected Patients Taking Antiretroviral Therapy

A Cohort Observational Study Evaluating Predictors, Incidence and Immunopathogenesis of Immune Reconstitution Syndrome (IRIS) in HIV-1 Infected Patients With CD4 Count Less Than or Equal to 100 Cells/microL Who Are Initiating Antiretroviral Therapy

National Institute of Allergy and Infectious Diseases (NIAID)

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.

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).

Pneumocystis

HIV/AIDS

Steroid

Conventional steroid regimen

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).

Shortened steroid regimen

Centro de Investigacion en Enfermedades Infecciosas

Short-term Steroid Therapy in Patients With P. Jirovecii Pneumonia Due to HIV / AIDS

Shortened Steroid Therapy in Patients With Moderate and Severe Pneumonia Due to P. Jirovecii Associated With HIV / AIDS

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.

To compare cumulative incidence of mortality in patients receiving the shortened steroid scheme or the conventional 21-day schedule, at 90 days

To compare mortality in patients receiving the shortened steroid scheme or the conventional 21-day schedule

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

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

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

To compare the time of intubation expressed in days of intubation,in subjects receiving the shortened steroid scheme or the conventional 21-day schedule

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)

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).

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)

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

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)

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)

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

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.

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.

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)

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)

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

To compare the changes in the diffusing lung capacity of carbon monoxide (DLCO) in patients receiving the shortened and conventional steroid scheme

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

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

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

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

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

Gustavo Reyes-Teran

Principal Investigator

Centro de Investigación en. Enfermedades Infecciosas, Mexico

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.

Placebo for 2 months followed by Combivir and efavirenz for 10 months

HIV Infections

Tuberculous Meningitis

Arm 1: Combivir and efavirenz for 12 months Arm 2: Placebo for 2 months then Combivir and efavirenz for 10 months

Combivir and efavirenz

Hospital for Tropical Diseases

Pham Ngoc Thach Hospital

Immediate Versus Deferred Antiretroviral Therapy for HIV-Associated Tuberculous Meningitis

Randomised Controlled Trial of Immediate Versus Deferred Antiretroviral Therapy for HIV-Associated Tuberculous Meningitis

Centre for Tropical Diseases

University of Oxford

Wellcome Trust

Females participants who are about to start first line antiretroviral therapy.

Herpes Virus-Related Illnesses

National Institutes of Health Clinical Center

Villa Maria Hospital Uganda

Herpesviruses Reactivation In Hiv-Infected Women Initiating ART (HERA)

On Day 0 (day of HIV diagnosis and study enrollment) participants will receive a chest x-ray and provide a sputum specimen for spot Xpert Ultra testing (48-hour results). Those with high clinical/radiographic suspicion for TB will start same-day TB treatment. On Day 2, participants will return for results of Xpert Ultra testing (spot specimen) and to provide a specimen for early morning Xpert Ultra testing. Those who are Xpert Ultra positive will start TB treatment. Those who are not diagnosed with TB will start ART on Day 9, after testing and treatment for other opportunistic infections. A liquid TB culture will be performed on both the spot and early morning specimens.

On Day 0 (day of HIV diagnosis and study enrollment) participants will receive a chest x-ray and Xpert Ultra testing with same-day results. Based on clinical symptoms, Xpert Ultra results, and chest x-ray, physician will determine whether or not the participant has tuberculosis. Those who are diagnosed with TB will start same-day TB treatment. Those who are not diagnosed with TB will start same-day ART.

Tuberculosis

Treatment with ART or TB medication on day of HIV diagnosis

Same-Day Treatment

Standard treatment

GHESKIO

A Trial of Same-Day Testing and Treatment to Improve Outcomes Among Symptomatic Patients Newly Diagnosed With HIV

Proportion of participants who are in care with HIV-1 RNA <200 copies/ml

Proportion of participants with HIV-1 RNA <50 copies/ml and <1000 copies/ml

Proportion of participants with 48-week adherence to ART of at least 90% by pharmacy refill records

Proportion of participants with perfect (100%) adherence as measured by 3-day self-report at 48 weeks after HIV testing

Proportion of participants meeting WHO criteria for ART failure and proportion initiating second-line ART during the study period

Sensitivity, specificity, predictive values, and likelihood ratios of spot and early morning Xpert Ultra results and chest x-ray, as single and as combined tests, with liquid culture as gold standard

Median time spent in clinic during first day and month of the study

Scores on the Connectedness to Treatment Setting Scale

Diagnosis of culture-positive TB after ART initiation (BACTEC MGIT 960, Becton Dickinson)

Incidence of paradoxical or unmasking IRIS

New Division of AIDS Grade 3 or Grade 4 signs, symptoms, or laboratory abnormalities that are at least a one-grade increase from baseline

Scores on the HRSA Patient Satisfaction Survey

Proportion of participants who report last missed dose of ART was at least 2 weeks ago

When the study has been completed, anonymized data will be made publicly available, which will permit replication of reported outcomes.

iris/fever

Immune Reconstitution Syndrome in HIV-Infected Patients Taking Antiretroviral Therapy

Short-term Steroid Therapy in Patients With P. Jirovecii Pneumonia Due to HIV / AIDS

Immediate Versus Deferred Antiretroviral Therapy for HIV-Associated Tuberculous Meningitis

Herpesviruses Reactivation In Hiv-Infected Women Initiating ART (HERA)

A Trial of Same-Day Testing and Treatment to Improve Outcomes Among Symptomatic Patients Newly Diagnosed With HIV

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