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A Randomized, Open-Label Trial of High Dose Atovaquone Versus Low Dose Atovaquone Versus Aerosolized Pentamidine for Prophylaxis of Pneumocystis Carinii Pneumonia in Patients With HIV Infection Who Are Intolerant of TMP/SMX
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.
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.
Age
13 - No limit years
Sex
ALL
Healthy Volunteers
No
Goodgame Med Group
Maitland, Florida, United States
Bay Area AIDS Consortium
Tampa, Florida, United States
Saint Vincent's Hosp and Med Ctr
New York, New York, United States
Holmes Hosp
Cincinnati, Ohio, United States
Hampton Roads Med Specialists
Hampton, Virginia, United States
Last Updated
June 24, 2005
615
Estimated participants
Atovaquone
DRUG
Pentamidine isethionate
DRUG
Lead Sponsor
Glaxo Wellcome
NCT04142047
NCT06694805
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT07428330