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Sponsored by: |
Glaxo Wellcome |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00001996 |
To compare the safety of atovaquone (566C80) with intravenous (IV) pentamidine for the treatment of mild to moderate Pneumocystis carinii pneumonia (PCP) in AIDS patients who are intolerant of therapy with trimethoprim / sulfamethoxazole (TMP / SMX) by comparing the incidence of premature discontinuation of therapy due to toxicity. To compare the efficacy of 566C80 with intravenous (IV) pentamidine for the treatment of mild to moderate PCP in the same population.
Condition | Intervention | Phase |
---|---|---|
Pneumonia, Pneumocystis Carinii HIV Infections |
Drug: Atovaquone Drug: Pentamidine isethionate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Safety Study |
Official Title: | A Phase II Open Randomized Comparison of 566C80 and Pentamidine Isethionate for the Treatment of Pneumocystis Carinii Pneumonia in AIDS Patients Who Are Intolerant of Trimethoprim / Sulfamethoxazole |
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have the following:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded.
Concurrent Medication:
Excluded:
Patients with the following are excluded:
Prior Medication:
Excluded:
Required:
United States, California | |
Davies Med Ctr | |
San Francisco, California, United States, 94114 | |
UCLA CARE Ctr | |
Los Angeles, California, United States, 90095 | |
UCI Med Ctr | |
Orange, California, United States, 92668 | |
East Bay AIDS Ctr | |
Berkeley, California, United States, 94704 | |
Kaiser Foundation Hosp | |
Harbor City, California, United States, 90710 | |
Dr Patrick Joseph | |
San Ramone, California, United States, 94583 | |
AIDS Community Research Consortium | |
Redwood City, California, United States, 94063 | |
Cedars Sinai Med Ctr | |
Los Angeles, California, United States, 90048 | |
United States, Georgia | |
Infectious Disease Research Consortium of Georgia | |
Atlanta, Georgia, United States, 30345 | |
United States, Massachusetts | |
Boston City Hosp | |
Boston, Massachusetts, United States, 02118 | |
Massachusetts Gen Hosp | |
Boston, Massachusetts, United States, 02114 | |
United States, New York | |
Saint Vincent's Hosp and Med Ctr | |
New York, New York, United States, 10011 | |
Beth Israel Med Ctr | |
New York, New York, United States, 10003 | |
Harlem AIDS Treatment Group / Harlem Hosp Ctr | |
New York, New York, United States, 10037 | |
United States, Ohio | |
Univ of Cincinnati | |
Cincinnati, Ohio, United States, 452670405 | |
United States, Oregon | |
Portland Veterans Adm Med Ctr / Rsch & Education Grp | |
Portland, Oregon, United States, 97210 | |
United States, Pennsylvania | |
Buckley Braffman Stern Med Associates | |
Philadelphia, Pennsylvania, United States, 19107 | |
United States, Tennessee | |
Regional Med Ctr at Memphis | |
Memphis, Tennessee, United States, 38103 | |
United States, Texas | |
Gathe, Joseph, M.D. | |
Houston, Texas, United States, 77004 | |
Baylor College of Medicine | |
Houston, Texas, United States, 77030 |
Study ID Numbers: | 053B, 05 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00001996 |
Health Authority: | United States: Food and Drug Administration |
Trimethoprim-Sulfamethoxazole Combination Pneumonia, Pneumocystis carinii Pentamidine Acquired Immunodeficiency Syndrome atovaquone |
Sexually Transmitted Diseases, Viral Trimethoprim Clotrimazole Miconazole Trimethoprim-Sulfamethoxazole Combination Pneumonia, Pneumocystis Mycoses Respiratory Tract Infections Respiratory Tract Diseases Pentamidine Retroviridae Infections Lung Diseases, Fungal Sulfamethoxazole |
Pneumocystosis Acquired Immunodeficiency Syndrome Tioconazole Immunologic Deficiency Syndromes Virus Diseases Folic Acid Pneumocystis Infections Atovaquone HIV Infections Lung Diseases Sexually Transmitted Diseases Pneumonia |
Anti-Infective Agents Trypanocidal Agents RNA Virus Infections Antiprotozoal Agents Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Enzyme Inhibitors Anti-Infective Agents, Urinary |
Folic Acid Antagonists Renal Agents Infection Pharmacologic Actions Antimalarials Antiparasitic Agents Antifungal Agents Therapeutic Uses Lentivirus Infections |