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A Controlled Comparative Trial of Sulfamethoxazole-Trimethoprim Versus Aerosolized Pentamidine for Secondary Prophylaxis of Pneumocystis carinii Pneumonia in AIDS Patients Receiving Azidothymidine (AZT) Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on A Controlled Comparative Trial of Sulfamethoxazole-Trimethoprim Versus Aerosolized Pentamidine for Secondary Prophylaxis of Pneumocystis carinii Pneumonia in AIDS Patients Receiving Azidothymidine (AZT) conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. A Controlled Comparative Trial of Sulfamethoxazole-Trimethoprim Versus Aerosolized Pentamidine for Secondary Prophylaxis of Pneumocystis carinii Pneumonia in AIDS Patients Receiving Azidothymidine (AZT) Clinical research trials and A Controlled Comparative Trial of Sulfamethoxazole-Trimethoprim Versus Aerosolized Pentamidine for Secondary Prophylaxis of Pneumocystis carinii Pneumonia in AIDS Patients Receiving Azidothymidine (AZT) health trials take place in a lot of 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 potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like A Controlled Comparative Trial of Sulfamethoxazole-Trimethoprim Versus Aerosolized Pentamidine for Secondary Prophylaxis of Pneumocystis carinii Pneumonia in AIDS Patients Receiving Azidothymidine (AZT). A Controlled Comparative Trial of Sulfamethoxazole-Trimethoprim Versus Aerosolized Pentamidine for Secondary Prophylaxis of Pneumocystis carinii Pneumonia in AIDS Patients Receiving Azidothymidine (AZT) Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a A Controlled Comparative Trial of Sulfamethoxazole-Trimethoprim Versus Aerosolized Pentamidine for Secondary Prophylaxis of Pneumocystis carinii Pneumonia in AIDS Patients Receiving Azidothymidine (AZT) clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their A Controlled Comparative Trial of Sulfamethoxazole-Trimethoprim Versus Aerosolized Pentamidine for Secondary Prophylaxis of Pneumocystis carinii Pneumonia in AIDS Patients Receiving Azidothymidine (AZT) condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Controlled Comparative Trial of Sulfamethoxazole-Trimethoprim Versus Aerosolized Pentamidine for Secondary Prophylaxis of Pneumocystis carinii Pneumonia in AIDS Patients Receiving Azidothymidine (AZT)  A Controlled Comparative Trial of Sulfamethoxazole-Trimethoprim Versus Aerosolized Pentamidine for Secondary Prophylaxis of Pneumocystis carinii Pneumonia in AIDS Patients Receiving Azidothymidine (AZT)
A Controlled Comparative Trial of Sulfamethoxazole-Trimethoprim Versus Aerosolized Pentamidine for Secondary Prophylaxis of Pneumocystis carinii Pneumonia in AIDS Patients Receiving Azidothymidine (AZT)
For Condition: Pneumonia, Pneumocystis carinii,HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To determine if the drug combination sulfamethoxazole-trimethoprim (SMX-TMP), given by mouth, and the drug pentamidine (PEN), given by inhaled aerosol, are effective in preventing a relapse of Pneumocystis carinii pneumonia (PCP) when they are given to patients who have recovered from a first episode of PCP and are being given zidovudine (AZT) to treat primary HIV infection. AZT prolongs survival in patients with AIDS and decreases the occurrence of opportunistic infections such as PCP. However, PCP recurs in about 43 percent of patients receiving AZT, indicating a need for other treatments to reduce the relapse rate. The two medications to be tested in this study, SMX/TMP and aerosolized PEN, have also been partially effective in preventing recurrence of PCP. It is hoped that the combination of AZT with these medications will be more effective than AZT or one of the medications alone.
Details: AZT prolongs survival in patients with AIDS and decreases the occurrence of opportunistic infections such as PCP. However, PCP recurs in about 43 percent of patients receiving AZT, indicating a need for other treatments to reduce the relapse rate. The two medications to be tested in this study, SMX/TMP and aerosolized PEN, have also been partially effective in preventing recurrence of PCP. It is hoped that the combination of AZT with these medications will be more effective than AZT or one of the medications alone. Patients receive the standard dose of AZT at study entry. Low body weight patients receive AZT at a lower dose. Patients are randomly assigned to one of two medications intended to prevent the recurrence of PCP. Patients assigned to SMX/TMP will take 1 capsule which contains both drugs once a day for 1 year. Patients assigned to PEN will have 1 aerosol treatment every 4 weeks for 1 year. Blood will be drawn at intervals in order to estimate blood levels of the drugs and to detect any adverse effects from the drugs. Note: Earlier versions of this protocol reflect its original design as a 3-arm study comparing aerosolized PEN, SMX/TMP, and pyrimethamine-sulfadoxine as secondary prophylaxis of PCP in AIDS patients receiving AZT. In order to reduce the effective sample size and permit the completion of accrual in a reasonable period of time, the pyrimethamine - sulfadoxine arm of this study has been discontinued. Patients randomized to this arm will be continued in this study on the original randomized therapy. Management of these patients will follow that described for SMX/TMP in the latest protocol version. AMENDED: Lower dose of AZT allowed.
Eligibility:
Study Type: Interventional, Treatment, Parallel Assignment, Pharmacokinetics Study
Minimum Age/Maximum Age: 12 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must fulfill the following criteria: - Randomization within 10 weeks of completing therapy for Pneumocystis carinii pneumonia (PCP). - Ability to tolerate oral and aerosolized therapy at the time of randomization. - Life expectancy > 4 months. Concurrent Medication: Allowed: - Inhaled bronchodilators for cough and bronchospasm related to aerosolized pentamidine treatment. - Aspirin at modest doses. - Ibuprofen at modest doses. - Acetaminophen at modest doses. - Erythropoietin for management of anemia. - Allowed to treat opportunistic infections while on study: - Acyclovir. - Ketoconazole. - Amphotericin B. - Nystatin. - Clotrimazole. - Also allowed: - Ganciclovir (DHPG) for maintenance therapy of life-threatening or sight-threatening cytomegalovirus retinitis (CMV retinitis) infection only. - Zidovudine (AZT) must be discontinued during the acute induction phase of treatment and will be restarted when maintenance therapy is introduced. Concurrent Treatment: Allowed: - Local radiation therapy for Kaposi's sarcoma. Prior Medication: Allowed: - Primary prophylactic therapy prior to Pneumocystis carinii pneumonia (PCP) episode. Risk Behavior: Allowed: - Patients maintained in a methadone maintenance program per local investigator's judgment. Exclusion Criteria - Active drug or alcohol abuse which would impair performance as a study subject. Concurrent Medication: Excluded: - Famotidine. - Any medications suspected of interference with the metabolism of zidovudine. - Flurazepam. - Chronic probenecid. - Phenobarbital. - Phenytoin. - Experimental therapies, except as noted. - Chronic oral bronchodilators should not be started in patients in order to maintain them on aerosolized pentamidine after they have exhibited pulmonary toxicity. Prior Medication: Excluded for the 30 patients who will undergo pharmacokinetic studies: - Zidovudine (AZT) at any time. - Excluded within 7 days of study entry for the 30 patients who will undergo pharmacokinetic studies: - Trimethoprim / sulfamethoxazole. - Pyrimethamine / sulfadoxine. - Aerosolized pentamidine. - Excluded: - Pentamidine by any route for the original infection. - Prophylactic therapy for Pneumocystis carinii pneumonia (PCP) between the discontinuation of acute treatment and study entry. Prior Treatment: Excluded within 2 weeks of study entry: - Transfusions of blood or red blood cells. Patients may not have any of the following symptoms or diseases: - Known treatment-limiting hypersensitivity to sulfonamides, trimethoprim, pyrimethamine, pentamidine, or zidovudine (AZT), especially but not limited to, exfoliative dermatitis, erythema multiforme, and Stevens-Johnson syndrome. - Development of severe hypoglycemia (serum glucose < 50 mg/dl with pentamidine therapy). - History of neoplasms other than basal cell carcinoma of the skin or carcinoma in situ of the cervix, or mucocutaneous Kaposi's sarcoma. - Known visceral Kaposi's sarcoma. - Known glucose-6-phosphate dehydrogenase (G-6-PD) deficiency.
Total Enrollment: 322
Location and Contact Information:
Overall Study Official:
HolzmanR, Study Chair,
Milton S Hershey Med Ctr
Hershey, Pennsylvania, 170330850
United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, 941102859
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
City Hosp Ctr at Elmhurst / Mount Sinai Hosp
Elmhurst, New York, 11373
United States
Homestead Private Office
Homestead, Pennsylvania, 15120
United States
UCLA CARE Ctr
Los Angeles, California, 90095
United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx, New York, 10461
United States
Stanford Univ School of Medicine
Stanford, California, 94305
United States
Univ of Massachusetts Med Ctr
Worcester, Massachusetts, 01655
United States
SUNY - Stony Brook
Stony Brook, New York, 117948153
United States
Duke Univ Med Ctr
Durham, North Carolina, 27710
United States
Summitt Med Ctr / San Francisco Gen Hosp
Oakland, California, 94609
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Sepulveda Veterans Adm Med Ctr / Olive View Med Ctr
Sylmar, California, 91342
United States
Harbor UCLA Med Ctr
Torrance, California, 90502
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
West Penn Hosp
Pittsburgh, Pennsylvania, 15224
United States
Boston Med Ctr
Boston, Massachusetts, 02118
United States
Shadyside Hosp
Pittsburgh, Pennsylvania, 15213
United States
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, 94115
United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
United States
Palo Alto Veterans Adm Med Ctr / Stanford Univ
Palo Alto, California, 94304
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Mem Sloan - Kettering Cancer Ctr
New York City, New York, 10021
United States
Holmes Hosp / Univ of Cincinnati Med Ctr
Cincinnati, Ohio, 452670405
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Univ of Pittsburgh Med School
Pittsburgh, Pennsylvania,
United States
Montefiore Med Ctr / Bronx Municipal Hosp
Bronx, New York, 10467
United States
Olive View Med Ctr
Sylmar, California, 91342
United States
Cornell Univ Med Ctr
New York City, New York, 10021
United States
Saint Francis' Med Ctr
Pittsburgh, Pennsylvania, 15201
United States
Beth Israel Med Ctr / Peter Krueger Clinic
New York City, New York, 10003
United States
Univ of Minnesota
Minneapolis, Minnesota, 55455
United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Univ of Washington
Seattle, Washington, 98105
United States
Presbyterian Univ Hosp
Pittsburgh, Pennsylvania, 15213
United States
Univ Hosp of Cleveland / Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Stanford Private Practice
Redwood City, California,
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Additional Information:
Study ID Numbers: ACTG 021;
Study Start Date:
Record last reviewed: September 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000727
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3. Interleukin 12 (IL-12) for the Treatment of Cryptosporidiosis in AIDS Patients
4. Effects on the Immune System of Anti-HIV Drugs in Patients Recently Infected with HIV
5. A Phase I Trial of HIV-1 C4-V3 Polyvalent Peptide Vaccine in HIV-1 Infected Persons
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A Controlled Comparative Trial of Sulfamethoxazole-Trimethoprim Versus Aerosolized Pentamidine for Secondary Prophylaxis of Pneumocystis carinii Pneumonia in AIDS Patients Receiving Azidothymidine (AZT)
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