Pneumonia, Pneumocystis Carinii, HIV Infections
Conditions
Keywords
Pneumonia, Pneumocystis carinii, Dapsone, Antifungal Agents, Acquired Immunodeficiency Syndrome, atovaquone
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.
Interventions
DRUGAtovaquone
DRUGDapsone
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Intervention model
PARALLEL
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No
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.
Countries
Tanzania, United States
Outcome results
None listed