A Comparison of Atovaquone and Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia in HIV-Infected Patients Who Cannot Take TMP/SMX
Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: August 1997
History of Changes
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.
Pneumonia, Pneumocystis Carinii
Drug : Atovaquone
Drug : Pentamidine isethionate
Primary Purpose: Treatment
|Official Title:||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|
Further study details as provided by NIH AIDS Clinical Trials Information Service:
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.Eligibility
|Ages Eligible for Study:||13 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Antimicrobial agents not specifically prohibited.
- HIV positivity.
- Prior PCP (histologically confirmed) OR documented CD4 count < 200 cells/mm3 OR constitutional symptoms such as thrush or unexplained fever (> 100 F) for 2 or more weeks.
- No current or suspected active PCP, and no signs of active PCP on chest x-ray.
- Prior intolerance to TMP/SMX or other trimethoprim or sulfa-containing regimens.
- Life-expectancy of at least 6 months.
- Pregnant women are eligible at the discretion of the investigator.
- Significant psychosis or emotional disorder that would preclude study compliance.
- Severe chronic diarrhea (e.g., > five stools/day) that may negatively affect absorption of oral medication.
- Unable to take oral medication or unable or unwilling to take medication with food.
- Other investigational agents except for drugs available through Treatment INDs or expanded access programs.
- Medications likely to have anti-pneumocystis effect (e.g., dapsone, trimethoprim, pyrimethamine, trimetrexate, other DHFR inhibitors, sulfadiazine, sulfamethoxazole, other sulfonamides, primaquine, clindamycin, and sulfonylureas.
- Corticosteroids in greater than physiologic replacement doses for more than 21 consecutive days.
- Systemic therapy for CNS toxoplasmosis, Kaposi's sarcoma, lymphoma, other active malignancies, or other disease that may decrease life expectancy or confound assessment.
- History of severe or intractable intolerance to atovaquone or aerosolized pentamidine.
- Prior hypoglycemia, pancreatitis, arrhythmias, or severe hypotension associated with any form of pentamidine.
- Prior enrollment in this protocol. Active substance abuse that would preclude study
Patients must have:
Patients with the following symptoms or conditions are excluded:
Patients with the following prior conditions are excluded:
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002340
Locations Show More
|United States, Florida|
|Goodgame Med Group|
|Maitland, Florida, United States, 32751|
|Bay Area AIDS Consortium|
|Tampa, Florida, United States, 33609|
|United States, New York|
|Saint Vincent's Hosp and Med Ctr|
|New York, New York, United States, 10011|
|United States, Ohio|
|Cincinnati, Ohio, United States, 452670405|
|United States, Virginia|
|Hampton Roads Med Specialists|
|Hampton, Virginia, United States, 23666|
Sponsors and CollaboratorsGlaxo Wellcome
|Responsible Party:||Glaxo Wellcome|
|ClinicalTrials.gov Identifier:||NCT00002340 History of Changes|
|Other Study ID Numbers:||227B|
|Study First Received:||November 2, 1999|
|Last Updated:||June 23, 2005|
Keywords provided by NIH AIDS Clinical Trials Information Service:Pneumonia, Pneumocystis carinii
Acquired Immunodeficiency Syndrome
Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
ClinicalTrials.gov processed this data on July 20, 2018
This information is provided by ClinicalTrials.gov.