Overview

A Randomized, Comparative Study of Daily Dapsone and Daily Atovaquone for Prophylaxis Against PCP in HIV-Infected Patients Who Are Intolerant of Trimethoprim and/or Sulfonamides

Status:
Completed

Trial end date:
1997-07-01

Target enrollment:
0

Participant gender:
All

Summary

To compare the efficacy and safety of dapsone versus atovaquone in preventing or delaying the onset of histologically proven or probable Pneumocystis carinii pneumonia in HIV-infected patients with CD4 counts <= 200 cells/mm3 or <= 15 percent of the total lymphocyte count who are intolerant to trimethoprim and/or sulfonamides. Trimethoprim/sulfamethoxazole (TMP/SMX), which is effective for secondary PCP prophylaxis, is associated with allergic manifestations and side effects that limit its use. Patients who are intolerant of TMP/SMX require an effective alternative. Dapsone and atovaquone have both shown promise as PCP prophylactic agents.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Treatments:

Atovaquone
Dapsone
Trimethoprim

Criteria

Inclusion Criteria

Concurrent Medication: Strongly recommended:

- Pyrimethamine (50 mg) and folinic acid (15 mg) weekly in patients receiving dapsone
who have CD4 count < 100 cells/mm3 and are toxoplasmosis seropositive.

Patients must have:

- Working diagnosis of HIV infection.

- CD4 count <= 200 cells/mm3 or <= 15 percent of total lymphocyte count at any time in
the past OR a history of PCP.

- History of intolerance of trimethoprim and/or sulfonamides that required permanent
discontinuation.

NOTE:

- Pregnant patients are eligible at the clinician's discretion.

Prior Medication:

Allowed:

- Prior PCP prophylaxis.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

- Active pneumocystosis.

Concurrent Medication:

Excluded:

- PCP prophylaxis (other than study drug) or any medication with potential anti-PCP
activity.

Patients with the following prior conditions are excluded:

- Known treatment-limiting reaction to dapsone or atovaquone.