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| Sponsor: | Glaxo Wellcome |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00001994 |
Purpose
To evaluate the safety and tolerance of atovaquone (566C80) in AIDS patients with central nervous system (CNS) toxoplasmosis. To evaluate the efficacy of 566C80 in the acute treatment and suppression of CNS toxoplasmosis in AIDS patients who fail or who cannot tolerate conventional therapy.
| Condition | Intervention |
|---|---|
|
Toxoplasmosis, Cerebral HIV Infections |
Drug: Atovaquone |
| Study Type: | Interventional |
| Study Design: | Treatment, Safety Study |
| Official Title: | A Pilot Study of 566C80 for the Salvage Treatment of Toxoplasmic Encephalitis in Patients Infected With the Human Immunodeficiency Virus (HIV) Who Have Failed or Are Intolerant of Pyrimethamine-Sulfadiazine |
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:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Concurrent Medication:
Excluded:
Patients with the following are excluded:
Active drug or alcohol abuse sufficient in the investigator's opinion to prevent compliance with the study regimen.
Contacts and Locations| United States, California | |
| San Francisco Gen Hosp | |
| San Francisco, California, United States, 941102859 | |
| Davies Med Ctr | |
| San Francisco, California, United States, 94114 | |
| Los Angeles County - USC Med Ctr | |
| Los Angeles, California, United States, 90033 | |
| UCSF - San Francisco Gen Hosp | |
| San Francisco, California, United States, 94110 | |
| Infectious Disease Med Group | |
| Oakland, California, United States, 94609 | |
| United States, District of Columbia | |
| Georgetown Univ Med Ctr | |
| Washington, District of Columbia, United States, 20007 | |
| United States, Georgia | |
| Infectious Disease Research Consortium of Georgia | |
| Atlanta, Georgia, United States, 30345 | |
| United States, Maryland | |
| Johns Hopkins Hosp | |
| Baltimore, Maryland, United States, 21205 | |
| United States, New York | |
| Harlem Hosp Ctr | |
| New York, New York, United States, 10037 | |
| 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 | |
| SUNY / Health Sciences Ctr at Stony Brook | |
| Stony Brook, New York, United States, 117948153 | |
| United States, North Carolina | |
| Duke Univ Med Ctr | |
| Durham, North Carolina, United States, 27710 | |
| United States, Oregon | |
| Portland Veterans Adm Med Ctr / Rsch & Education Grp | |
| Portland, Oregon, United States, 97210 | |
| 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 | |
| United States, Virginia | |
| Infectious Disease Physicians Inc | |
| Annandale, Virginia, United States, 22203 | |
| Canada, Alberta | |
| Southern Alberta HIV Clinic / Foothills Hosp | |
| Calgary, Alberta, Canada | |
| Canada, British Columbia | |
| Dr Julio S G Montaner | |
| Vancouver, British Columbia, Canada | |
| Canada, Ontario | |
| Wellesley Hosp | |
| Toronto, Ontario, Canada | |
| Canada, Quebec | |
| Dr Emil Toma / Hotel Dieu de Montreal | |
| Montreal, Quebec, Canada | |
More Information
| Study ID Numbers: | 101A, 02 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00001994 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Toxoplasmosis AIDS-Related Opportunistic Infections Naphthoquinones Encephalitis Acquired Immunodeficiency Syndrome |
|
Pyrimethamine Anti-Infective Agents Communicable Diseases Antiprotozoal Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Toxoplasmosis, Cerebral Central Nervous System Viral Diseases Infection Brain Diseases Central Nervous System Parasitic Infections Antimalarials Antiparasitic Agents Therapeutic Uses |
Suppuration Parasitic Diseases Coccidiostats Retroviridae Infections Protozoan Infections RNA Virus Infections Immune System Diseases Coccidiosis Acquired Immunodeficiency Syndrome Nervous System Diseases Central Nervous System Diseases Brain Abscess Enzyme Inhibitors Folic Acid Antagonists Pharmacologic Actions |