A Randomized, Double-Blind Study of 566C80 Versus Septra (Sulfamethoxazole/Trimethoprim) for the Treatment of Pneumocystis Carinii Pneumonia in AIDS Patients
5 other identifiers
interventional
300
8 countries
38
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
38 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
Primary Completion
Last participant's last visit for primary outcome
January 1, 1992
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedMarch 1, 2011
February 1, 2011
November 2, 1999
February 25, 2011
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
- +17 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (38)
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Kaiser Foundation Hosp
Harbor City, California, 90710, United States
USC
Los Angeles, California, 90033, United States
Dr Richard Meyer
Los Angeles, California, 90048, United States
UCLA CARE Ctr
Los Angeles, California, 90095, United States
Infectious Disease Med Group
Oakland, California, 94609, United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325, United States
San Francisco Gen Hosp
San Francisco, California, 941102859, United States
UCSF - San Francisco Gen Hosp
San Francisco, California, 94110, United States
Dr Marcus Conant
San Francisco, California, 94115, United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007, United States
Veterans Administration Med Ctr
Washington D.C., District of Columbia, 20422, United States
Dr Winkler Weinberg
Roswell, Georgia, 30076, United States
Johns Hopkins Univ School of Medicine
Baltimore, Maryland, 21205, 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
Beth Israel Med Ctr / Peter Krueger Clinic
New York, New York, 10003, United States
Saint Vincent's Hosp and Med Ctr
New York, New York, 10011, United States
Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York, New York, 10037, United States
Duke Univ Med Ctr
Durham, North Carolina, 27710, United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405, United States
Good Samaritan Hosp
Portland, Oregon, 972103079, United States
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, 19107, United States
Regional Med Ctr at Memphis
Memphis, Tennessee, 38103, United States
The Regional Medical Ctr, Memphis
Memphis, Tennessee, 38105, United States
Plaza Med Ctr
Houston, Texas, 77004, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
CHU Saint Pierre
Brussels, Belgium
Dr Julio S G Montaner
Vancouver, British Columbia, Canada
Wellesley Hosp
Toronto, Ontario, Canada
Montreal Gen Hosp
Montreal, Quebec, Canada
Hopital Bichat - Claude Bernard
Paris, France
August-Viktoria-Krankenhaus Chefarst derII Inneren Abteilung
Berlin, Germany
Universitat Munchen / Medizinische Poliklinik
Munich, Germany
Natac Med Centre
Amsterdam, Netherlands
San Juan Veterans Administration Med Ctr
San Juan, 009275800, Puerto Rico
Kobler Centre / Saint Stephen's Hosp
London, United Kingdom
Saint Mary's Hosp
London, United Kingdom
Related Publications (2)
Hughes W, et al. Comparison of 566C80 & trimethoprim-sulfamethoxazole (TMP-SMZ) for the treatment of P. carinii pneumonitis (PCP). An International Multicenter, CCTG & ACTG Collaboration. Int Conf AIDS. 1992 Jul 19-24;8(1):We48 (abstract no WeB 1019)
BACKGROUNDHughes W, Leoung G, Kramer F, Bozzette SA, Safrin S, Frame P, Clumeck N, Masur H, Lancaster D, Chan C, et al. Comparison of atovaquone (566C80) with trimethoprim-sulfamethoxazole to treat Pneumocystis carinii pneumonia in patients with AIDS. N Engl J Med. 1993 May 27;328(21):1521-7. doi: 10.1056/NEJM199305273282103.
PMID: 8479489BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hughes WT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Primary Completion
January 1, 1992
Last Updated
March 1, 2011
Record last verified: 2011-02