Search / Trial NCT00000707

Aerosols in the Treatment of Asymptomatic Pneumocystis Pneumonia: A Pilot Study Assessing the Effectiveness of Aerosolized Pentamidine as Treatment of Subclinical Pneumocystis Infection in Patients With No Clinical Symptoms

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of December 10, 2023

Completed

Keywords

Respiratory Function Tests Aids Related Opportunistic Infections Pneumonia, Pneumocystis Carinii Pentamidine Lung Hiv Seropositivity Drug Evaluation Administration, Inhalation Aerosols Acquired Immunodeficiency Syndrome

Description

Many AIDS patients develop PCP, but the effectiveness of early diagnosis and treatment of PCP is not known. The effectiveness of PEN may be improved if treatment is begun when the parasite burden (the number of organisms in the lung) is still small, and before respiratory symptoms appear. If PFT of HIV-infected patients is able to identify patients in the early stages of infection, outpatient treatment of these patients offers a possible alternative to the expense and toxicity of continuous preventive therapy of all high-risk patients. Patients are treated with aerosolized PEN on an outpat...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Treatment:
  • Allowed during aerosolization:
  • Metaproterenol or albuterol to treat bronchospasm.
  • Patients must have:
  • HIV infection confirmed by ELISA, HIV culture, or p24 antigenemia.
  • Suspected subclinical Pneumocystis carinii infection as detected by > 10 percent change in lung volumes and/or diffusing capacity indicative of progressive restrictive disease as detected by monthly screening pulmonary function tests (PFT's). Patients will be afebrile and have no respiratory signs or symptoms of clinical disease. Morphologic confirmation of pneumocysts will be determined by bronchoalveolar lavage (BAL) performed 24 hours after the initial aerosol inhalation. If the BAL is negative for pneumocysts, the patient will be withdrawn from this protocol and will be followed per the screening PFT protocol at Stony Brook.
  • Diagnostic bronchoscopy and BAL must be performed within 2 weeks of detection of > 10 percent change in PFTs.
  • Ability and willingness to sign informed consent.
  • Prior Medication:
  • Allowed:
  • Primary prophylaxis with agents active against Pneumocystis carinii pneumonia (PCP), but no more than 5 patients may have received prior prophylaxis with aerosolized pentamidine.
  • Zidovudine.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following conditions or symptoms are excluded:
  • History of Pneumocystis carinii pneumonia (PCP).
  • Development of respiratory signs and/or symptoms in the interval between detection of pulmonary function test (PFT) abnormality and the time of initial aerosol deposition.
  • Dyspnea, cough, or bronchospasm that prevents cooperation with aerosol administration.
  • History of a major adverse reaction to pentamidine defined by absolute neutropenia, < 750 polymorphonuclear leukocytes plus bands; thrombocytopenia, < 40000 platelets; creatinine rise, > 3.0 mg/dl; liver function abnormalities, SGOT or SGPT > 5 x normal; hypoglycemia, < 50 mg/dl; rash, exfoliative or mucositis; cough, unremitting cough or bronchospasm uncontrolled by bronchodilator preventing > 50 percent of dose delivered for > 2 days.
  • Concurrent Medication:
  • Excluded:
  • Zidovudine.
  • Patients unable to cooperate with aerosol administration are excluded.
  • Prior Medication:
  • Excluded:
  • - Another antiprotozoal regimen for this episode. Unable to complete therapy or follow-up for social reasons in the opinion of the investigator.

Attachments

readout_NCT00000707_2023-12-10.pdf

4.5 MB

NCT00000707_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Stony Brook, New York, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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