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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000707 |
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.
Condition | Intervention |
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Pneumonia, Pneumocystis Carinii HIV Infections |
Drug: Pentamidine isethionate |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | 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 |
Estimated Enrollment: | 20 |
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 outpatient basis. The aerosol therapy is given by a respiratory therapist 5 times a week, for a total of 21 days of treatment. In addition, patients participate in two radioactive aerosol studies in which the patient inhales a radioactive gas while sitting with his/her back against a gamma camera. The resulting picture outlines the lungs. Then the gas is exhaled and the patient breathes an aerosol of PEN. This mist contains a single dose of PEN mixed with a small amount of radioactivity (99mTc-pertechnetate). The gamma camera determines where the particles deposit in the lungs. The radioactive exposure is equivalent to a typical x-ray of the ribs. Patients also undergo diagnostic bronchoscopy with lavage, and PFT. Blood is drawn to measure the blood level of PEN. Patients are followed (clinical exams and PFT's) for 6 months after the end of therapy. Prophylaxis for PCP is allowed during the 6-month follow-up.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Treatment:
Allowed during aerosolization:
Metaproterenol or albuterol to treat bronchospasm.
Patients must have:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Concurrent Medication:
Excluded:
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.
Study ID Numbers: | ACTG 048 |
Study First Received: | November 2, 1999 |
Last Updated: | July 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00000707 |
Health Authority: | United States: Federal Government |
Respiratory Function Tests AIDS-Related Opportunistic Infections Pneumonia, Pneumocystis carinii Pentamidine Lung |
HIV Seropositivity Drug Evaluation Administration, Inhalation Aerosols Acquired Immunodeficiency Syndrome |
Opportunistic Infections Sexually Transmitted Diseases, Viral Clotrimazole Pneumocystosis Miconazole Acquired Immunodeficiency Syndrome Tioconazole Immunologic Deficiency Syndromes Virus Diseases Mycoses Pneumonia, Pneumocystis Respiratory Tract Infections |
Respiratory Tract Diseases Pneumocystis Infections HIV Seropositivity HIV Infections Lung Diseases AIDS-Related Opportunistic Infections Sexually Transmitted Diseases Pentamidine Retroviridae Infections Pneumonia Lung Diseases, Fungal |
Communicable Diseases Anti-Infective Agents Trypanocidal Agents RNA Virus Infections Antiprotozoal Agents Slow Virus Diseases Immune System Diseases |
Infection Pharmacologic Actions Antiparasitic Agents Antifungal Agents Therapeutic Uses Lentivirus Infections |