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A Randomized, Double-Blind Study of 566C80 Versus Septra (Sulfamethoxazole/Trimethoprim) for the Treatment of Pneumocystis carinii Pneumonia in AIDS Patients Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on A Randomized, Double-Blind Study of 566C80 Versus Septra (Sulfamethoxazole/Trimethoprim) for the Treatment of Pneumocystis carinii Pneumonia in AIDS Patients conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Randomized, Double-Blind Study of 566C80 Versus Septra (Sulfamethoxazole/Trimethoprim) for the Treatment of Pneumocystis carinii Pneumonia in AIDS Patients Clinical research trials and A Randomized, Double-Blind Study of 566C80 Versus Septra (Sulfamethoxazole/Trimethoprim) for the Treatment of Pneumocystis carinii Pneumonia in AIDS Patients healthcare trials take place in many of cities 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 evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including A Randomized, Double-Blind Study of 566C80 Versus Septra (Sulfamethoxazole/Trimethoprim) for the Treatment of Pneumocystis carinii Pneumonia in AIDS Patients. A Randomized, Double-Blind Study of 566C80 Versus Septra (Sulfamethoxazole/Trimethoprim) for the Treatment of Pneumocystis carinii Pneumonia in AIDS Patients Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a A Randomized, Double-Blind Study of 566C80 Versus Septra (Sulfamethoxazole/Trimethoprim) for the Treatment of Pneumocystis carinii Pneumonia in AIDS Patients clinical trial. Test subjects oftentimes recieve the best healthcare possible for their A Randomized, Double-Blind Study of 566C80 Versus Septra (Sulfamethoxazole/Trimethoprim) for the Treatment of Pneumocystis carinii Pneumonia in AIDS Patients condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Randomized, Double-Blind Study of 566C80 Versus Septra (Sulfamethoxazole/Trimethoprim) for the Treatment of Pneumocystis carinii Pneumonia in AIDS Patients  A Randomized, Double-Blind Study of 566C80 Versus Septra (Sulfamethoxazole/Trimethoprim) for the Treatment of Pneumocystis carinii Pneumonia in AIDS Patients
A Randomized, Double-Blind Study of 566C80 Versus Septra (Sulfamethoxazole/Trimethoprim) for the Treatment of Pneumocystis carinii Pneumonia in AIDS Patients
For Condition: Pneumonia, Pneumocystis carinii,HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Glaxo Wellcome
Synopsis: To evaluate the effectiveness of atovaquone (566C80) compared to a standard antipneumocystis agent, (SMX/TMP), for the treatment of mild to moderate Pneumocystis carinii pneumonia (PCP) in AIDS patients. To compare the safety of short-term (21 days) treatment with 566C80 and SMX/TMP in AIDS patients with an acute episode of PCP. Standard therapies for acute treatment of PCP involve either SMX/TMP or pentamidine isetionate. Although both treatments are equally effective, side effects prevent completion of therapy in 11-55 percent of patients.
Details: Standard therapies for acute treatment of PCP involve either SMX/TMP or pentamidine isetionate. Although both treatments are equally effective, side effects prevent completion of therapy in 11-55 percent of patients. Patients are randomized into one of two treatment groups to receive either (1) 566C80 for 21 days, or (2) SMX/TMP for 21 days. Patients will be stratified according to severity of PCP. Group A will be those with an arterial-alveolar (A-a) DO2 < 35 mm Hg. Group B will have an A-a DO2 of 35-45 mm Hg., and will also be required to receive therapy with Corticosteroids. All doses are taken with food. During the 21 days of treatment, patients are examined clinically for adverse effects and have hematology (blood-related) and clinical chemistry studies conducted a minimum of 2 times weekly. More frequent monitoring may be required at the discretion of the investigator. To evaluate the effectiveness of study medication, the clinical status of each patient is evaluated 2 to 3 times per week (e.g., dyspnea score, cough score, chest tightness/pain score, vital signs). Also, on days 7 and 21 of treatment, an arterial blood gas measurement and chest X-ray are performed. Patients who experience severe toxicities will be discontinued from the study and placed on alternative therapy. Patients will also be removed from study if they show significant clinical deterioration within the first 7 days of therapy or if there is no improvement after 10 days of therapy. This study involves a double placebo with one group randomized to receive oral 566C80 and placebo tablets which look like SMX/TMP while the other group will receive SMX/TMP and placebo tablets looking like 566C80.
Eligibility:
Study Type: Interventional, Treatment, Parallel Assignment, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patient must have the following: - Presumptive diagnosis of AIDS as defined by the CDC. - Untreated Pneumocystis carinii pneumonia (PCP). - Willingness and ability to give informed consent. Prior Medication: Allowed: - Prophylactic therapy for Pneumocystis carinii pneumonia (PCP) including aerosolized pentamidine or sulfamethoxazole/trimethoprim (SMX/TMP) (at a dose no greater than two DS tablets twice daily). Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: - Judged by the investigator to be in impending respiratory failure. - Malabsorption or vomiting that would, in the judgment of 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. Concurrent Medication: Excluded: - Corticosteroid treatment (except replacement therapy or patients in Group B). - Ganciclovir. - Zidovudine (AZT). - Investigational agents including antiretroviral agents (didanosine (ddI), dideoxycytidine (ddC), etc.). Drugs likely to have anti-pneumocystis effect such as: - Sulfonamides. - Pentamidine. - Dapsone. - Trimethoprim. - Other DHFR inhibitors. - Primaquine. - Clindamycin. - Sulfonylureas. Patients with the following are excluded: - Judged by the investigator to be in impending respiratory failure. - Prior therapy for this episode of PCP or treatment within 4 weeks of entry for a prior episode of PCP. - Unable to or refuse to discontinue zidovudine, ganciclovir, or other antiretroviral agents during the 21 day treatment period. - Unable to take medication orally or unwilling or unable to take study medication with food. - Significant psychosis or emotional disorder such that, in the investigator's opinion, the patient would not be compliant with the study protocol. - Prior documented glucose-6-phosphate dehydrogenase (G6PD) deficiency. - Prior history of life-threatening toxicity to SMX/TMP such as severe rash or Stevens-Johnson syndrome. Prior Medication: Excluded: - Prior therapy for this episode of Pneumocystis carinii pneumonia (PCP) or treatment within 4 weeks for a prior episode of PCP. - Blood transfusions.
Total Enrollment: 300
Location and Contact Information:
Overall Study Official:
HughesWT, Study Chair,
San Juan Veterans Administration Med Ctr
San Juan, , 009275800
Puerto Rico
Saint Mary's Hosp
London, ,
United Kingdom
Good Samaritan Hosp
Portland, Oregon, 972103079
United States
Dr Winkler Weinberg
Roswell, Georgia, 30076
United States
Dr Julio S G Montaner
Vancouver, British Columbia,
Canada
Regional Med Ctr at Memphis
Memphis, Tennessee, 38103
United States
Kaiser Foundation Hosp
Harbor City, California, 90710
United States
Kobler Centre / Saint Stephen's Hosp
London, ,
United Kingdom
Infectious Disease Med Group
Oakland, California, 94609
United States
Veterans Administration Med Ctr
Washington D.C., District of Columbia, 20422
United States
August-Viktoria-Krankenhaus Chefarst derII Inneren Abteilung
Berlin 41, ,
Germany
Universitat Munchen / Medizinische Poliklinik
Munich 2, ,
Germany
Plaza Med Ctr
Houston, Texas, 77004
United States
Beth Israel Med Ctr / Peter Krueger Clinic
New York City, New York, 10003
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
Wellesley Hosp
Toronto, Ontario,
Canada
USC
Los Angeles, California, 90033
United States
Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York City, New York, 10037
United States
UCLA CARE Ctr
Los Angeles, California, 90095
United States
Johns Hopkins Univ School of Medicine
Baltimore, Maryland, 21205
United States
Hopital Bichat - Claude Bernard
Paris, ,
France
Univ of Cincinnati
Cincinnati, Ohio, 452670405
United States
CHU Saint Pierre
Brussels, ,
Belgium
Saint Vincent's Hosp and Med Ctr
New York City, New York, 10011
United States
Dr Richard Meyer
Los Angeles, California, 90048
United States
Duke Univ Med Ctr
Durham, North Carolina, 27710
United States
The Regional Medical Ctr, Memphis
Memphis, Tennessee, 38105
United States
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, 19107
United States
UCSF - San Francisco Gen Hosp
San Francisco, California, 94110
United States
Natl Inst of Allergy & Infect Dis / Cln Ctr
Bethesda, Maryland, 20892
United States
Washington Univ School of Medicine
St. Louis, Missouri, 63108
United States
Montreal Gen Hosp
Montreal, Quebec,
Canada
Natac Med Centre
Amsterdam, ,
Netherlands
San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
United States
Dr Marcus Conant
San Francisco, California, 94115
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
United States
Additional Information:
Study ID Numbers: ACTG 167; NIAID 90-CC-185,Protocol #03,FDA 53A,Project P71
Study Start Date:
Record last reviewed: March 1992
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000655
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A Randomized, Double-Blind Study of 566C80 Versus Septra (Sulfamethoxazole/Trimethoprim) for the Treatment of Pneumocystis carinii Pneumonia in AIDS Patients
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