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

NCT00000707 | Completed

• 2 other identifiers: ACTG 04811022
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

To confirm the ability of pulmonary (lung) function testing (PFT) to detect Pneumocystis carinii pneumonia (PCP) before the development of clinical symptoms and to determine if pentamidine (PEN), a drug used in treating PCP, can be given effectively as an aerosol (inhaled mist). Other goals include the measurement of the actual amount of PEN that reaches the lung, and to determine if close clinical observation is safer and as effective as drug therapy for the prevention of subsequent episodes of PCP. 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.

Conditions

Pneumonia, Pneumocystis Carinii; HIV Infections

Keywords

Respiratory Function Tests; AIDS-Related Opportunistic Infections; Pneumonia, Pneumocystis carinii; Pentamidine; Lung; HIV Seropositivity; Drug Evaluation; Administration, Inhalation; Aerosols; Acquired Immunodeficiency Syndrome

Interventions

Pentamidine isethionate DRUG

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

SUNY - Stony Brook

Stony Brook, New York, 11794, United States

Location

Related Publications (1)

• Smaldone GC, Fuhrer J, Steigbigel RT, McPeck M. Factors determining pulmonary deposition of aerosolized pentamidine in patients with human immunodeficiency virus infection. Am Rev Respir Dis. 1991 Apr;143(4 Pt 1):727-37. doi: 10.1164/ajrccm/143.4_Pt_1.727.

  PMID: 2008984 BACKGROUND

MeSH Terms

Conditions

Pneumonia, Pneumocystis; HIV Infections; AIDS-Related Opportunistic Infections; HIV Seropositivity; Respiratory Aspiration; Acquired Immunodeficiency Syndrome

Interventions

Pentamidine

Condition Hierarchy (Ancestors)

Lung Diseases, Fungal; Mycoses; Bacterial Infections and Mycoses; Infections; Pneumocystis Infections; Respiratory Tract Infections; Pneumonia; Lung Diseases; Respiratory Tract Diseases; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Opportunistic Infections; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Benzamidines; Amidines; Organic Chemicals

Study Officials

• Smaldone G

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: June 1, 1991
• Last Updated: November 2, 2021

Record last verified: 2021-10

Locations

US (1)