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A Controlled Trial Comparing the Efficacy of Aerosolized Pentamidine and Parenteral/Oral Sulfamethoxazole-Trimethoprim in the Treatment of Pneumocystis carinii Pneumonia in AIDS Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about A Controlled Trial Comparing the Efficacy of Aerosolized Pentamidine and Parenteral/Oral Sulfamethoxazole-Trimethoprim in the Treatment of Pneumocystis carinii Pneumonia in AIDS conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Controlled Trial Comparing the Efficacy of Aerosolized Pentamidine and Parenteral/Oral Sulfamethoxazole-Trimethoprim in the Treatment of Pneumocystis carinii Pneumonia in AIDS Clinical research trials and A Controlled Trial Comparing the Efficacy of Aerosolized Pentamidine and Parenteral/Oral Sulfamethoxazole-Trimethoprim in the Treatment of Pneumocystis carinii Pneumonia in AIDS medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like A Controlled Trial Comparing the Efficacy of Aerosolized Pentamidine and Parenteral/Oral Sulfamethoxazole-Trimethoprim in the Treatment of Pneumocystis carinii Pneumonia in AIDS. A Controlled Trial Comparing the Efficacy of Aerosolized Pentamidine and Parenteral/Oral Sulfamethoxazole-Trimethoprim in the Treatment of Pneumocystis carinii Pneumonia in AIDS Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a A Controlled Trial Comparing the Efficacy of Aerosolized Pentamidine and Parenteral/Oral Sulfamethoxazole-Trimethoprim in the Treatment of Pneumocystis carinii Pneumonia in AIDS clinical trial. Test subjects typically obtain the finest healthcare available for their A Controlled Trial Comparing the Efficacy of Aerosolized Pentamidine and Parenteral/Oral Sulfamethoxazole-Trimethoprim in the Treatment of Pneumocystis carinii Pneumonia in AIDS condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Controlled Trial Comparing the Efficacy of Aerosolized Pentamidine and Parenteral/Oral Sulfamethoxazole-Trimethoprim in the Treatment of Pneumocystis carinii Pneumonia in AIDS  A Controlled Trial Comparing the Efficacy of Aerosolized Pentamidine and Parenteral/Oral Sulfamethoxazole-Trimethoprim in the Treatment of Pneumocystis carinii Pneumonia in AIDS
A Controlled Trial Comparing the Efficacy of Aerosolized Pentamidine and Parenteral/Oral Sulfamethoxazole-Trimethoprim in the Treatment of Pneumocystis carinii Pneumonia in AIDS
For Condition: Pneumonia, Pneumocystis carinii,HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To compare the safety and effectiveness of drug therapy with aerosolized pentamidine (PEN) with that of conventional therapy, sulfamethoxazole plus trimethoprim (SMX/TMP) in the treatment of Pneumocystis carinii pneumonia (PCP) in patients who have AIDS, are HIV positive, or are at high risk for HIV infection. New treatments are needed for PCP, a common lung infection in patients with AIDS, because many patients treated with the two standard treatments, PEN given by injections and SMX/TMP, have had adverse effects that required a change in treatment. There is also a high relapse rate after the standard treatments. Preliminary experiments in humans suggest that aerosolized PEN is as effective as the standard treatments for PCP, and causes few adverse effects.
Details: New treatments are needed for PCP, a common lung infection in patients with AIDS, because many patients treated with the two standard treatments, PEN given by injections and SMX/TMP, have had adverse effects that required a change in treatment. There is also a high relapse rate after the standard treatments. Preliminary experiments in humans suggest that aerosolized PEN is as effective as the standard treatments for PCP, and causes few adverse effects. Patients entered in the study are randomly assigned to aerosolized PEN or to intravenous SMX/TMP, for a 21-day trial. SMX/TMP is given 4 times a day and aerosolized PEN once a day. Doses are determined by body size. Patients who receive aerosolized PEN also receive a placebo intravenous injection and patients who receive SMX/TMP also receive a placebo aerosol. Patients are hospitalized at least 5 days. Patients who improve may be discharged after 5 days at the discretion of the attending physician. Discharged patients continue the study with oral SMX/TMP and aerosolized placebo or aerosolized PEN and oral placebo. Patients who fail to respond or who develop severe adverse effects are switched to intravenous PEN or other standard therapy. During the 21-day trial, zidovudine (AZT) may not be used. AZT may be resumed after therapy for the acute PCP episode is completed.
Eligibility:
Study Type: Interventional, Treatment, Parallel Assignment
Minimum Age/Maximum Age: 12 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Prior Medication: Allowed: - Zidovudine (AZT), but must be suspended during study medication. Unequivocal diagnosis of Pneumocystis carinii pneumonia established by morphologic confirmation of three or more typical Pneumocystis carinii organisms in sputum, bronchoalveolar lavage fluid, or lung tissue obtained by transbronchial or open-lung biopsy within 3 days before or after randomization. If morphologic confirmation is not possible prior to therapy, patients may be randomized if the investigator believes there is a high suspicion of PCP based on clinical presentation. If morphologic diagnosis cannot be established within 5 days of randomization, the patient will be withdrawn from study therapy. Resting (A-a) DO2 less than 30 torr on room air at all ACTG sites except San Francisco General Hospital. Non-ACTG sites will enter patients up to a resting (A-a) DO2less than 55 mmHg on room air. Exclusion Criteria Co-existing Condition: Patients with the following are excluded: - Dyspnea, cough, bronchospasm, or other reasons causing inability to cooperate with aerosol administration. - History of major adverse reaction to pentamidine or sulfonamide-containing preparation defined as: - Absolute neutropenia of 750 or less PMN + bands cells/mm3. - Thrombocytopenia below 40000 platelets/mm3. - Rise in creatinine: - To more than 3.0 mg/dl. - Liver function abnormalities: - SGOT or SGPT greater than 5 x upper limit of normal. - Hypoglycemia below 50 mg/dl. - Rash: - Exfoliative or mucositis. - Cough: - Unremitting or bronchospasm uncontrolled by bronchodilator preventing more than 50 percent of delivered dose for more than 2 days. Concurrent Medication: Excluded: - Other drugs for the treatment or prevention of AIDS or Pneumocystis carinii pneumonia. - Zidovudine (AZT). Patients with the following are excluded: - Dyspnea, cough, bronchospasm, or other reasons causing inability to cooperate with aerosol administration. - History of major adverse reaction to pentamidine or sulfonamide-containing preparation defined as: - Absolute neutropenia of 750 or less PMN + bands cells/mm3. - Thrombocytopenia lower than 40000 platelets/mm3. - Rise in creatinine: - To greater than 3.0 mg/dl. - Liver function abnormalities: - SGOT or SGPT greater than 5 x upper limit of normal. - Hypoglycemia less than 50 mg/dl. - Rash: - Exfoliative or mucositis. - Cough: - Unremitting or bronchospasm uncontrolled by bronchodilator preventing more than 50 percent of delivered dose for more than 2 days. Prior Medication: Excluded within 14 days of study entry: - Systemic steroids higher than adrenal replacement doses. - Excluded within 6 weeks of study entry: - Another antiprotozoal regimen for this episode, whether therapeutic or prophylactic. - Sulfamethoxazole / trimethoprim. - Pyrimethamine. - Sulfadoxine / pyrimethamine. - Pentamidine. - Eflornithine.
Total Enrollment: 240
Location and Contact Information:
Overall Study Official:
BMontgomery, Study Chair,
Holmes Hosp / Univ of Cincinnati Med Ctr
Cincinnati, Ohio, 452670405
United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx, New York, 10461
United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Univ Hosp of Cleveland / Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
United States
Additional Information:
Study ID Numbers: ACTG 040;
Study Start Date:
Record last reviewed: February 1992
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000715
Other Hiv Infections Studies:
1. A Phase I Safety and Pharmacokinetics Study of 2',3'-Dideoxyinosine (ddI) Administered Twice Daily to Infants and Children With AIDS or Symptomatic HIV Infection
2. A Treatment IND for 566C80 Therapy of Pneumocystis carinii Pneumonia
3. Active Immunization of Asymptomatic, HIV-Infected Individuals With Recombinant GP160 HIV-1 Antigen: A Phase I/II Study of Immunogenicity and Toxicity
4. A Study of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia
5. Methadone Effects on Zidovudine (ZDV, AZT) Disposition
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A Controlled Trial Comparing the Efficacy of Aerosolized Pentamidine and Parenteral/Oral Sulfamethoxazole-Trimethoprim in the Treatment of Pneumocystis carinii Pneumonia in AIDS
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