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A Phase II Open Randomized Comparison of 566C80 and Pentamidine Isethionate for the Treatment of Pneumocystis carinii Pneumonia in AIDS Patients Who are Intolerant of Trimethoprim / Sulfamethoxazole Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about A Phase II Open Randomized Comparison of 566C80 and Pentamidine Isethionate for the Treatment of Pneumocystis carinii Pneumonia in AIDS Patients Who are Intolerant of Trimethoprim / Sulfamethoxazole conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Phase II Open Randomized Comparison of 566C80 and Pentamidine Isethionate for the Treatment of Pneumocystis carinii Pneumonia in AIDS Patients Who are Intolerant of Trimethoprim / Sulfamethoxazole Clinical research trials and A Phase II Open Randomized Comparison of 566C80 and Pentamidine Isethionate for the Treatment of Pneumocystis carinii Pneumonia in AIDS Patients Who are Intolerant of Trimethoprim / Sulfamethoxazole health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like A Phase II Open Randomized Comparison of 566C80 and Pentamidine Isethionate for the Treatment of Pneumocystis carinii Pneumonia in AIDS Patients Who are Intolerant of Trimethoprim / Sulfamethoxazole. A Phase II Open Randomized Comparison of 566C80 and Pentamidine Isethionate for the Treatment of Pneumocystis carinii Pneumonia in AIDS Patients Who are Intolerant of Trimethoprim / Sulfamethoxazole Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a A Phase II Open Randomized Comparison of 566C80 and Pentamidine Isethionate for the Treatment of Pneumocystis carinii Pneumonia in AIDS Patients Who are Intolerant of Trimethoprim / Sulfamethoxazole clinical trial. Subjects frequently get the best healthcare possible for their A Phase II Open Randomized Comparison of 566C80 and Pentamidine Isethionate for the Treatment of Pneumocystis carinii Pneumonia in AIDS Patients Who are Intolerant of Trimethoprim / Sulfamethoxazole condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Phase II Open Randomized Comparison of 566C80 and Pentamidine Isethionate for the Treatment of Pneumocystis carinii Pneumonia in AIDS Patients Who are Intolerant of Trimethoprim / Sulfamethoxazole  A Phase II Open Randomized Comparison of 566C80 and Pentamidine Isethionate for the Treatment of Pneumocystis carinii Pneumonia in AIDS Patients Who are Intolerant of Trimethoprim / Sulfamethoxazole
A Phase II Open Randomized Comparison of 566C80 and Pentamidine Isethionate for the Treatment of Pneumocystis carinii Pneumonia in AIDS Patients Who are Intolerant of Trimethoprim / Sulfamethoxazole
For Condition: Pneumonia, Pneumocystis carinii,HIV Infections
Status: Completed
Sponsor(s): Glaxo Wellcome ,
Synopsis: To compare the safety of atovaquone (566C80) with intravenous (IV) pentamidine for the treatment of mild to moderate Pneumocystis carinii pneumonia (PCP) in AIDS patients who are intolerant of therapy with trimethoprim / sulfamethoxazole (TMP / SMX) by comparing the incidence of premature discontinuation of therapy due to toxicity. To compare the efficacy of 566C80 with intravenous (IV) pentamidine for the treatment of mild to moderate PCP in the same population.
Details:
Eligibility:
Study Type: Interventional, Treatment, Open Label, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have the following: - History of, or are currently experiencing, intolerance to TMP / SMX, or to another sulfonamide, which required discontinuation of therapy. - Pneumocystis carinii pneumonia (PCP). - Willing and able to give informed consent. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded. - Malabsorption disorder or vomiting that would, in the judgement of the investigator, potentially limit the retention and absorption of an oral therapy. - Concurrent bacterial, fungal, or viral pneumonitis, pulmonary Kaposi's sarcoma, or other concurrent illness, or chronic pulmonary disease that, in the investigator's opinion, would make interpretation of drug efficacy difficult. - Present occurrences of abnormal prolongation of QT interval on standard, 12 lead EKG. Concurrent Medication: Excluded: - Drugs with potential anti-pneumocystis effect (eg: - sulfonamides, dapsone, trimethoprim, other dihydrofolate reductase (DHFR) inhibitors, primaquine, clindamycin, sulfonylureas). - Ganciclovir. - Zidovudine. - Investigational agents including anti-retroviral agents (ddI, ddC, etc.). Patients receiving these drugs prior to entry must discontinue their use during the therapy phase (21 days) of the trial. - Corticosteroids (except replacement therapy) during the 21 day treatment period (Strata A and C Patients). - Class 1A antiarrhythmics (ie: - quinidine, procainamide, disopyramide). Patients with the following are excluded: - Judged by the investigator to be in impending respiratory failure. - Known intolerance to parenteral pentamidine isethionate, or therapeutic failure with same for treatment of current episode of PCP. - Significant psychosis or emotional disorder that, in the investigator's opinion, would preclude the patient from adhering to the protocol. - Inability or unwillingness to take medication orally or with food. - Prior documented glucose-6-phosphate dehydrogenase (G6PD) deficiency. - History, or present occurrences, of abnormal prolongation of QT interval on standard, 12 lead EKG. - Termination from FDA 053A due to toxicity. - For patients entering under historic intolerance criteria (Groups A and B), prior therapy for this episode of PCP is an exclusion. Prior Medication: Excluded: - Treatment within 4 weeks of entry for a prior episode of PCP. - For patients entering under historic intolerance criteria (Groups A and B), prior therapy for this episode of PCP is an exclusion. Required: - Adjuvant prednisone for patient enrolled in Strata B or D.
Total Enrollment:
Location and Contact Information:
Infectious Disease Research Consortium of Georgia
Atlanta, Georgia, 30345
United States
East Bay AIDS Ctr
Berkeley, California, 94704
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
Saint Vincent's Hosp and Med Ctr
New York City, New York, 10011
United States
UCI Med Ctr
Orange, California, 92668
United States
Massachusetts Gen Hosp
Boston, Massachusetts, 02114
United States
UCLA CARE Ctr
Los Angeles, California, 90095
United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, 97210
United States
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, 19107
United States
Dr Patrick Joseph
San Ramon, California, 94583
United States
Davies Med Ctr
San Francisco, California, 94114
United States
Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York City, New York, 10037
United States
Gathe, Joseph, M.D.
Houston, Texas, 77004
United States
Beth Israel Med Ctr
New York City, New York, 10003
United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405
United States
Regional Med Ctr at Memphis
Memphis, Tennessee, 38103
United States
Boston City Hosp
Boston, Massachusetts, 02118
United States
Cedars Sinai Med Ctr
Los Angeles, California, 90048
United States
Kaiser Foundation Hosp
Harbor City, California, 90710
United States
AIDS Community Research Consortium
Redwood City, California, 94063
United States
Additional Information:
Study ID Numbers: 053B; 05
Study Start Date:
Record last reviewed: May 1992
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001996
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4. A Double-Blind Randomized Clinical Trial of a Rifabutin Regimen in the Treatment of Mycobacterium-avium Complex (MAC) Bacteremia in Patients With AIDS
5. A Multicenter Phase II Double-Blind Exploratory Study to Evaluate Differences Among Various Zidovudine/Didanosine Regimens on Quantitative Measures of Viral Burden in Relatively Early HIV-1 Infection
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A Phase II Open Randomized Comparison of 566C80 and Pentamidine Isethionate for the Treatment of Pneumocystis carinii Pneumonia in AIDS Patients Who are Intolerant of Trimethoprim / Sulfamethoxazole
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