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

Study Overview
=================
Brief 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.

Detailed Description
-----------------
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.

Official Title
-----------------
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

Conditions
-----------------
Pneumonia, Pneumocystis Carinii, HIV Infections

Intervention / Treatment
-----------------
* Drug: Atovaquone
* Drug: Dapsone


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 13 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Parallel Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Atovaquone|nan|
|Drug: Dapsone|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pneumonia, Pneumocystis carinii, Dapsone, Antifungal Agents, Acquired Immunodeficiency Syndrome, atovaquone