A Study of Pentamidine Plus Dapsone in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Patients Who Cannot Take Trimethoprim or Sulfonamides
NCT ID: NCT00001028
Last Updated: 2021-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
400 participants
INTERVENTIONAL
1994-06-30
Brief Summary
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Both aerosolized pentamidine and dapsone have been shown to prevent PCP, but both drugs cause side effects. This study attempts to determine which drug is more efficacious as prophylaxis against PCP in patients who cannot tolerate trimethoprim/sulfamethoxazole.
Detailed Description
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Patients are evenly divided between two treatment arms to receive either aerosolized pentamidine every 4 weeks or dapsone orally three times weekly. Follow-up data is collected every 3 months, and patients are clinically evaluated every 6 months. Patients who develop PCP or a severe or persistent study drug toxicity may be switched to the alternative study drug at the clinician's discretion. Average duration of follow-up is 2 years.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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Pentamidine isethionate
Dapsone
Eligibility Criteria
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Inclusion Criteria
* HIV infection.
* CD4 count \<= 200 cells/mm3 or \<= 15 percent of total lymphocytes OR a history of prior PCP.
* History of intolerance to trimethoprim and/or sulfonamides.
* No active pneumocystosis. Patient or guardian must sign informed consent. Pregnant patients are eligible at the clinician's discretion. Patients who do not meet required laboratory values may be eligible at the discretion of the clinician.
Exclusion Criteria
Excluded:
* Any medication with potential anti-PCP activity.
Patients with the following prior conditions are excluded:
* Treatment-limiting reaction to pentamidine or dapsone.
13 Years
ALL
No
Sponsors
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Jacobus Pharmaceutical
INDUSTRY
Fujisawa Pharmaceutical Co
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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El-Sadr W
Role: STUDY_CHAIR
Luskin-Hawk R
Role: STUDY_CHAIR
Locations
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Community Consortium of San Francisco
San Francisco, California, United States
Denver CPCRA / Denver Public Hlth
Denver, Colorado, United States
Wilmington Hosp / Med Ctr of Delaware
Wilmington, Delaware, United States
Veterans Administration Med Ctr / Regional AIDS Program
Washington D.C., District of Columbia, United States
AIDS Research Alliance - Chicago
Chicago, Illinois, United States
Wishard Hosp / Indiana Univ Hosp
Indianapolis, Indiana, United States
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
New Orleans, Louisiana, United States
Comprehensive AIDS Alliance of Detroit
Detroit, Michigan, United States
Henry Ford Hosp
Detroit, Michigan, United States
North Jersey Community Research Initiative
Newark, New Jersey, United States
Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York, New York, United States
Bronx Lebanon Hosp Ctr
The Bronx, New York, United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, United States
Richmond AIDS Consortium
Richmond, Virginia, United States
Countries
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References
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el-Sadr W, Wentworth D, Dehlinger M, Larntz K. Design and implementation of a community-based trial for prophylaxis for P. carinii pneumonia (PCP). Int Conf AIDS. 1993 Jun 6-11;9(1):79 (abstract no WS-B36-2)
Other Identifiers
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11565
Identifier Type: REGISTRY
Identifier Source: secondary_id
CPCRA 013
Identifier Type: -
Identifier Source: org_study_id