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.

Study Timeline

• Study Completion: 1997-07
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-27
• Last Update Posted: 2021-11-04

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

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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