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Sponsored by: |
Glaxo Wellcome |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002340 |
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.
Condition | Intervention | Phase |
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Pneumonia, Pneumocystis Carinii HIV Infections |
Drug: Atovaquone Drug: Pentamidine isethionate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Safety Study |
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 |
Estimated Enrollment: | 615 |
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.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Concurrent Treatment:
Allowed:
Patients must have:
NOTE:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
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 | |
Holmes Hosp | |
Cincinnati, Ohio, United States, 452670405 | |
United States, Virginia | |
Hampton Roads Med Specialists | |
Hampton, Virginia, United States, 23666 |
Study ID Numbers: | 227B, 230 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002340 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Pneumonia, Pneumocystis carinii Pentamidine Antifungal Agents |
Acquired Immunodeficiency Syndrome AIDS-Related Complex atovaquone |
Anti-Infective Agents Sexually Transmitted Diseases, Viral Pneumocystosis Acquired Immunodeficiency Syndrome AIDS-Related Complex Immunologic Deficiency Syndromes Virus Diseases Antimalarials Mycoses Pneumonia, Pneumocystis Atovaquone |
Pneumocystis Infections Respiratory Tract Diseases Respiratory Tract Infections HIV Infections Antifungal Agents Lung Diseases Sexually Transmitted Diseases Pentamidine Retroviridae Infections Pneumonia Lung Diseases, Fungal |
Trypanocidal Agents Communicable Diseases Anti-Infective Agents Antiprotozoal Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Infection Antimalarials Pneumonia, Pneumocystis Mycoses Antiparasitic Agents Respiratory Tract Diseases Respiratory Tract Infections Therapeutic Uses |
Antifungal Agents Pentamidine Retroviridae Infections Lung Diseases, Fungal RNA Virus Infections Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Pharmacologic Actions Immunologic Deficiency Syndromes Virus Diseases Pneumocystis Infections Atovaquone HIV Infections Lung Diseases |