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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

Trial Information

Current as of May 09, 2025

Completed

Keywords

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

ClinConnect Summary

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 If the BAL is negative for pneumocysts, the patient will be withdrawn from this protocol and will be followed per the screening PFT protocol at Stony Brook.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.

About National Institute Of Allergy And Infectious Diseases (Niaid)

The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.

Locations

Stony Brook, New York, United States

Patients applied

0 patients applied

Trial Officials

Smaldone G

Study Chair

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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