A Study of Pentamidine Plus Dapsone in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Patients Who Cannot Take Trimethoprim or Sulfonamides
Completed · Phase 3
Conditions studied: Pneumonia, Pneumocystis Carinii, HIV Infections
In brief
To compare the safety and efficacy of aerosolized pentamidine and dapsone in the prevention of Pneumocystis carinii pneumonia (PCP) in high-risk HIV-infected patients who are intolerant to trimethoprim and/or sulfonamides. 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.
Key facts
- Study ID
- NCT00001028
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 400
- Expected to finish
- 1994-06-01
- Last updated by the study team
- 2021-11-01
Who can join
Age: 13 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients must have:
- 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.
You may not qualify if…
- Concurrent Medication:
- Excluded:
- Any medication with potential anti-PCP activity.
- Patients with the following prior conditions are excluded:
- Treatment-limiting reaction to pentamidine or dapsone.
Where it is running
- 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
Full record on ClinicalTrials.gov
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