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| Sponsor: | Glaxo Wellcome |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00001996 |
Purpose
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: | Endpoint Classification: Safety Study Masking: Open Label Primary Purpose: Treatment |
| 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 |
Eligibility| 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:
Contacts and Locations| United States, California | |
| East Bay AIDS Ctr | |
| Berkeley, California, United States, 94704 | |
| Kaiser Foundation Hosp | |
| Harbor City, California, United States, 90710 | |
| Cedars Sinai Med Ctr | |
| Los Angeles, California, United States, 90048 | |
| UCLA CARE Ctr | |
| Los Angeles, California, United States, 90095 | |
| UCI Med Ctr | |
| Orange, California, United States, 92668 | |
| AIDS Community Research Consortium | |
| Redwood City, California, United States, 94063 | |
| Davies Med Ctr | |
| San Francisco, California, United States, 94114 | |
| Dr Patrick Joseph | |
| San Ramone, California, United States, 94583 | |
| 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 | |
More Information
| ClinicalTrials.gov Identifier: | NCT00001996 History of Changes |
| Other Study ID Numbers: | 053B, 05 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
|
Trimethoprim-Sulfamethoxazole Combination Pneumonia, Pneumocystis carinii Pentamidine Acquired Immunodeficiency Syndrome atovaquone |
|
HIV Infections Acquired Immunodeficiency Syndrome Pneumonia Pneumonia, Pneumocystis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Lung Diseases Respiratory Tract Diseases |
Respiratory Tract Infections Lung Diseases, Fungal Mycoses Pneumocystis Infections Pentamidine Trimethoprim Trimethoprim-Sulfamethoxazole Combination Atovaquone Sulfamethoxazole Antifungal Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antiprotozoal Agents Antiparasitic Agents |