Status:
COMPLETED
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
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Pneumonia, Pneumocystis Carinii
HIV Infections
Eligibility:
All Genders
13+ years
Phase:
PHASE3
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 CD...
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 o...
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
July 1 1997
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT00000802
End Date
July 1 1997
Last Update
November 4 2021
Active Locations (44)
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1
Alabama Therapeutics CRS
Birmingham, Alabama, United States, 35294
2
USC CRS
Los Angeles, California, United States, 900331079
3
Stanford CRS
Palo Alto, California, United States, 943055107
4
Ucsd, Avrc Crs
San Diego, California, United States, 921036325