A Comparison of Atovaquone and Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia in HIV-Infected Patients Who Cannot Take TMP/SMX

Phase 3

Completed

• Conditions: Pneumonia, Pneumocystis Carinii; HIV Infections

• Registration Number: NCT00002340
• Lead Sponsor: Glaxo Wellcome

Brief Summary

To assess whether high dose or low dose atovaquone suspension is more effective than aerosolized pentamidine as prophylaxis against Pneumocystis carinii pneumonia (PCP) in high-risk HIV-infected patients. To compare the safety of chronic administration of the three regimens in patients with advanced HIV disease. To determine the relationship between steady state atovaquone plasma concentrations and prophylactic efficacy against PCP.

Detailed Description

Patients are randomized to receive oral atovaquone at 1 of 2 doses once daily or aerosolized pentamidine once every 4 weeks. Treatment continues until 18 months after the last patient is enrolled. Patients are stratified into primary or secondary prophylaxis strata based on prior occurrence of a PCP episode.

Study Timeline

• Status Verified: 1997-08
• 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: 615

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (5)

Holmes Hosp; 🇺🇸 Cincinnati, Ohio, United States

Hampton Roads Med Specialists; 🇺🇸 Hampton, Virginia, United States

Bay Area AIDS Consortium; 🇺🇸 Tampa, Florida, United States

Goodgame Med Group; 🇺🇸 Maitland, Florida, United States

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