A Phase II Open Randomized Comparison of 566C80 and Pentamidine Isethionate for the Treatment of Pneumocystis Carinii Pneumonia in AIDS Patients Who Are Intolerant of Trimethoprim / Sulfamethoxazole

Phase 2

Completed

• Conditions: Pneumonia, Pneumocystis Carinii; HIV Infections

• Registration Number: NCT00001996
• Lead Sponsor: Glaxo Wellcome

Brief Summary

To compare the safety of atovaquone (566C80) with intravenous (IV) pentamidine for the treatment of mild to moderate Pneumocystis carinii pneumonia (PCP) in AIDS patients who are intolerant of therapy with trimethoprim / sulfamethoxazole (TMP / SMX) by comparing the incidence of premature discontinuation of therapy due to toxicity. To compare the efficacy of 566C80 with intravenous (IV) pentamidine for the treatment of mild to moderate PCP in the same population.

Detailed Description

Not available

Study Timeline

• Status Verified: 1992-05
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (20)

UCI Med Ctr; 🇺🇸 Orange, California, United States

Cedars Sinai Med Ctr; 🇺🇸 Los Angeles, California, United States

AIDS Community Research Consortium; 🇺🇸 Redwood City, California, United States

Dr Patrick Joseph; 🇺🇸 San Ramone, California, United States

East Bay AIDS Ctr; 🇺🇸 Berkeley, California, United States

Davies Med Ctr; 🇺🇸 San Francisco, California, United States

Kaiser Foundation Hosp; 🇺🇸 Harbor City, California, United States

UCLA CARE Ctr; 🇺🇸 Los Angeles, California, United States

Infectious Disease Research Consortium of Georgia; 🇺🇸 Atlanta, Georgia, United States

Boston City Hosp; 🇺🇸 Boston, Massachusetts, United States

Massachusetts Gen Hosp; 🇺🇸 Boston, Massachusetts, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

Portland Veterans Adm Med Ctr / Rsch & Education Grp; 🇺🇸 Portland, Oregon, United States

Saint Vincent's Hosp and Med Ctr; 🇺🇸 New York, New York, United States

Harlem AIDS Treatment Group / Harlem Hosp Ctr; 🇺🇸 New York, New York, United States

Regional Med Ctr at Memphis; 🇺🇸 Memphis, Tennessee, United States

Gathe, Joseph, M.D.; 🇺🇸 Houston, Texas, United States

Beth Israel Med Ctr; 🇺🇸 New York, New York, United States

Univ of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States

Buckley Braffman Stern Med Associates; 🇺🇸 Philadelphia, Pennsylvania, United States