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

• Status: Completed
• Trial end date: 1994-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborators: Fujisawa Pharmaceutical Co; Jacobus Pharmaceutical
• Treatments: Dapsone; Pentamidine; Trimethoprim

Criteria

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.