A Randomized, Double-Blind Study of 566C80 Versus Septra (Sulfamethoxazole/Trimethoprim) for the Treatment of Pneumocystis Carinii Pneumonia in AIDS Patients
- Conditions
- Pneumonia, Pneumocystis CariniiHIV Infections
- Registration Number
- NCT00000655
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (38)
Georgetown Univ Med Ctr
🇺🇸Washington, District of Columbia, United States
Univ of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Veterans Administration Med Ctr
🇺🇸Washington, District of Columbia, United States
Natl Inst of Allergy & Infect Dis / Cln Ctr
🇺🇸Bethesda, Maryland, United States
Good Samaritan Hosp
🇺🇸Portland, Oregon, United States
Regional Med Ctr at Memphis
🇺🇸Memphis, Tennessee, United States
The Regional Medical Ctr, Memphis
🇺🇸Memphis, Tennessee, United States
CHU Saint Pierre
🇧🇪Brussels, Belgium
Wellesley Hosp
🇨🇦Toronto, Ontario, Canada
Dr Julio S G Montaner
🇨🇦Vancouver, British Columbia, Canada
Montreal Gen Hosp
🇨🇦Montreal, Quebec, Canada
Hopital Bichat - Claude Bernard
🇫🇷Paris, France
August-Viktoria-Krankenhaus Chefarst derII Inneren Abteilung
🇩🇪Berlin 41, Germany
Universitat Munchen / Medizinische Poliklinik
🇩🇪Munich 2, Germany
Natac Med Centre
🇳🇱Amsterdam, Netherlands
San Juan Veterans Administration Med Ctr
🇵🇷San Juan, Puerto Rico
Kobler Centre / Saint Stephen's Hosp
🇬🇧London, United Kingdom
Kaiser Foundation Hosp
🇺🇸Harbor City, California, United States
USC
🇺🇸Los Angeles, California, United States
Dr Richard Meyer
🇺🇸Los Angeles, California, United States
UCLA CARE Ctr
🇺🇸Los Angeles, California, United States
Univ of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Infectious Disease Med Group
🇺🇸Oakland, California, United States
Univ of California / San Diego Treatment Ctr
🇺🇸San Diego, California, United States
San Francisco Gen Hosp
🇺🇸San Francisco, California, United States
Dr Winkler Weinberg
🇺🇸Roswell, Georgia, United States
Beth Israel Med Ctr / Peter Krueger Clinic
🇺🇸New York, New York, United States
Saint Vincent's Hosp and Med Ctr
🇺🇸New York, New York, United States
Harlem AIDS Treatment Group / Harlem Hosp Ctr
🇺🇸New York, New York, United States
Duke Univ Med Ctr
🇺🇸Durham, North Carolina, United States
Washington Univ School of Medicine
🇺🇸St Louis, Missouri, United States
Buckley Braffman Stern Med Associates
🇺🇸Philadelphia, Pennsylvania, United States
Plaza Med Ctr
🇺🇸Houston, Texas, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Saint Mary's Hosp
🇬🇧London, United Kingdom
Johns Hopkins Univ School of Medicine
🇺🇸Baltimore, Maryland, United States
UCSF - San Francisco Gen Hosp
🇺🇸San Francisco, California, United States
Dr Marcus Conant
🇺🇸San Francisco, California, United States