A Study of Pentamidine Plus Dapsone in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Patients Who Cannot Take Trimethoprim or Sulfonamides
A Study of Pentamidine Plus Dapsone in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Patients Who Cannot Take Trimethoprim or Sulfonamides
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.
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.

 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.
Inclusion Criteria

 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.

 Exclusion Criteria

 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.