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
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
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.
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.

 Patients are randomized to receive either dapsone or atovaquone daily, with follow-up at the
 clinic every 4 months.
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.