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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

Phase 3
Completed
Conditions
Pneumonia, Pneumocystis Carinii
HIV Infections
Registration Number
NCT00000802
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
700
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (44)

Alabama Therapeutics CRS

🇺🇸

Birmingham, Alabama, United States

USC CRS

🇺🇸

Los Angeles, California, United States

Stanford CRS

🇺🇸

Palo Alto, California, United States

Ucsd, Avrc Crs

🇺🇸

San Diego, California, United States

Ucsf Aids Crs

🇺🇸

San Francisco, California, United States

Santa Clara Valley Med. Ctr.

🇺🇸

San Jose, California, United States

San Mateo County AIDS Program

🇺🇸

San Mateo, California, United States

Harbor-UCLA Med. Ctr. CRS

🇺🇸

Torrance, California, United States

University of Colorado Hospital CRS

🇺🇸

Aurora, Colorado, United States

Howard University Hosp., Div. of Infectious Diseases, ACTU

🇺🇸

Washington, District of Columbia, United States

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Alabama Therapeutics CRS
🇺🇸Birmingham, Alabama, United States

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