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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 Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on 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 conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. 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 Clinical research trials and 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 healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as 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. 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 Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a 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 clinical trial. Human subjects often receive the most effective healthcare possible for their 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 condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > 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  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
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
For Condition: Pneumonia, Pneumocystis carinii,HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Open Label
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 20
Location and Contact Information:
Overall Study Official:
SmaldoneG, Study Chair,
SUNY - Stony Brook
Stony Brook, New York, 117948153
United States
Additional Information:
Study ID Numbers: ACTG 048;
Study Start Date:
Record last reviewed: June 1991
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000707
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4. Comparing the Effects of Smoked and Oral Marijuana in Individuals with HIV/AIDS
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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
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