- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002340
A Comparison of Atovaquone and Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia in HIV-Infected Patients Who Cannot Take TMP/SMX
June 23, 2005 updated by: Glaxo Wellcome
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment
615
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Maitland, Florida, United States, 32751
- Goodgame Med Group
-
Tampa, Florida, United States, 33609
- Bay Area AIDS Consortium
-
-
New York
-
New York, New York, United States, 10011
- Saint Vincent's Hosp and Med Ctr
-
-
Ohio
-
Cincinnati, Ohio, United States, 452670405
- Holmes Hosp
-
-
Virginia
-
Hampton, Virginia, United States, 23666
- Hampton Roads Med Specialists
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria
Concurrent Medication:
Allowed:
- Antimicrobial agents not specifically prohibited.
Concurrent Treatment:
Allowed:
- Transfusion.
Patients must have:
- 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.
NOTE:
- Pregnant women are eligible at the discretion of the investigator.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- 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.
Concurrent Medication:
Excluded:
- Rifampin.
- 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.
Patients with the following prior conditions are excluded:
- 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 compliance.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
November 2, 1999
First Submitted That Met QC Criteria
August 30, 2001
First Posted (Estimate)
August 31, 2001
Study Record Updates
Last Update Posted (Estimate)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
August 1, 1997
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Lung Diseases
- Bacterial Infections and Mycoses
- Mycoses
- Slow Virus Diseases
- Lung Diseases, Fungal
- Pneumocystis Infections
- HIV Infections
- Infections
- Pneumonia
- Acquired Immunodeficiency Syndrome
- Pneumonia, Pneumocystis
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antifungal Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Antimalarials
- Trypanocidal Agents
- Atovaquone
- Pentamidine
Other Study ID Numbers
- 227B
- 230
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HIV Infections
-
University of MinnesotaWithdrawnHIV Infections | HIV/AIDS | Hiv | AIDS | Aids/Hiv Problem | AIDS and InfectionsUnited States
-
University of California, San DiegoUniversity of California, Los Angeles; University of Southern California; California... and other collaboratorsCompleted
-
Gérond'ifRecruiting
-
University of California, DavisCompleted
-
University of California, San DiegoNational Center for Complementary and Integrative Health (NCCIH)CompletedHIV PositiveUnited States
-
University of ChicagoUniversity of Athens; National Development and Research Institutes, Inc.Completed
-
HIV Prevention Trials NetworkNational Institute on Drug Abuse (NIDA); National Institute of Allergy and...CompletedHIV PositiveIndonesia, Ukraine, Vietnam
-
University of ZimbabweCompleted
-
Florida International UniversityCompleted
-
Boston Children's HospitalNational Institute on Minority Health and Health Disparities (NIMHD)Completed
Clinical Trials on Pentamidine isethionate
-
FisonsCompletedHIV Infections | Pneumonia, Pneumocystis CariniiUnited States
-
National Institute of Allergy and Infectious Diseases...CompletedHIV Infections | Pneumonia, Pneumocystis CariniiUnited States
-
FisonsCompletedHIV Infections | Pneumonia, Pneumocystis CariniiUnited States
-
National Institute of Allergy and Infectious Diseases...CompletedHIV Infections | Pneumonia, Pneumocystis CariniiUnited States
-
FisonsCompletedHIV Infections | Pneumonia, Pneumocystis CariniiUnited States
-
LyphoMedCompletedHIV Infections | Pneumonia, Pneumocystis CariniiUnited States
-
National Institute of Allergy and Infectious Diseases...CompletedHIV Infections | Pneumonia, Pneumocystis CariniiUnited States
-
FisonsCompletedHIV Infections | Pneumonia, Pneumocystis CariniiUnited States
-
FisonsCompletedHIV Infections | Pneumonia, Pneumocystis CariniiUnited States
-
Gyongyi SzaboNational Institute on Alcohol Abuse and Alcoholism (NIAAA); The Cleveland Clinic and other collaboratorsWithdrawnHepatic SteatosisUnited States