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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.
Toxoplasmosis, Cerebral HIV Infections
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Drug: Atovaquone
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U.S. FDA Resources
| Study Type: |
Interventional |
| Study Design: |
Treatment, Safety Study |
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| 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 |
| Ages Eligible for Study: |
13 Years and older |
| Genders Eligible for Study: |
Both |
| Accepts Healthy Volunteers: |
No |
Inclusion Criteria
Patients must have the following:
- Presumptive diagnosis of AIDS.
- Cerebral toxoplasmosis.
- Expected survival of at least four weeks without therapy.
- Willing and able to give informed consent.
Prior Medication:
Allowed:
- Pyrimethamine-sulfonamide.
- Clindamycin-sulfonamide.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
- Significant emotional disorder or psychosis.
- Evidence of significant malabsorption, ileus or significant emesis at entry which would inhibit drug absorption.
- Other known central nervous system lesions such as lymphoma, tuberculoma, cryptococcoma, active neurosyphilis. Unwilling or unable to take 566C80 with a meal, enteral supplements (eg:
- Ensure Plus) or pulverized form through a nasogastric tube.
- Active drug or alcohol abuse sufficient in the investigator's opinion to prevent compliance with the study regimen.
Concurrent Medication:
Excluded:
- Drugs with potential anti-toxoplasmosis activity including sulfone, sulfonamide, trimethoprim, pyrimethamine and clindamycin during the acute therapy phase of the trial.
- First three weeks of treatment:
- Retrovir (zidovudine) or any investigational agent including antiretroviral agents (eg:
- ddI,ddC).
Patients with the following are excluded:
- Significant emotional disorder or psychosis.
- Evidence of significant malabsorption, ileus or significant emesis at entry which would inhibit drug absorption.
- Other known central nervous system lesions such as lymphoma, tuberculoma, cryptococcoma, active neurosyphilis. Unwilling or unable to take 566C80 with a meal, enteral supplements (eg:
- Ensure Plus) or pulverized form through a nasogastric tube.
- Active drug or alcohol abuse sufficient in the investigator's opinion to prevent compliance with the study regimen.
Active drug or alcohol abuse sufficient in the investigator's opinion to prevent compliance with the study regimen.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001994
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| San Francisco Gen Hosp |
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| San Francisco, California, United States, 941102859 |
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| Davies Med Ctr |
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| San Francisco, California, United States, 94114 |
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| Los Angeles County - USC Med Ctr |
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| Los Angeles, California, United States, 90033 |
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| UCSF - San Francisco Gen Hosp |
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| San Francisco, California, United States, 94110 |
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| Infectious Disease Med Group |
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| Oakland, California, United States, 94609 |
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| Georgetown Univ Med Ctr |
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| Washington, District of Columbia, United States, 20007 |
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| Infectious Disease Research Consortium of Georgia |
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| Atlanta, Georgia, United States, 30345 |
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| Johns Hopkins Hosp |
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| Baltimore, Maryland, United States, 21205 |
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| Harlem Hosp Ctr |
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| New York, New York, United States, 10037 |
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| Saint Vincent's Hosp and Med Ctr |
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| New York, New York, United States, 10011 |
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| Beth Israel Med Ctr |
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| New York, New York, United States, 10003 |
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| SUNY / Health Sciences Ctr at Stony Brook |
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| Stony Brook, New York, United States, 117948153 |
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| Duke Univ Med Ctr |
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| Durham, North Carolina, United States, 27710 |
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| Portland Veterans Adm Med Ctr / Rsch & Education Grp |
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| Portland, Oregon, United States, 97210 |
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| Regional Med Ctr at Memphis |
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| Memphis, Tennessee, United States, 38103 |
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| Gathe, Joseph, M.D. |
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| Houston, Texas, United States, 77004 |
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| Baylor College of Medicine |
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| Houston, Texas, United States, 77030 |
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| Infectious Disease Physicians Inc |
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| Annandale, Virginia, United States, 22203 |
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| Southern Alberta HIV Clinic / Foothills Hosp |
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| Calgary, Alberta, Canada |
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| Dr Julio S G Montaner |
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| Vancouver, British Columbia, Canada |
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| Wellesley Hosp |
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| Toronto, Ontario, Canada |
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| Dr Emil Toma / Hotel Dieu de Montreal |
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| Montreal, Quebec, Canada |
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| San Francisco Gen Hosp |
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| San Francisco, California, United States, 941102859 |
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| Davies Med Ctr |
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| San Francisco, California, United States, 94114 |
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| Los Angeles County - USC Med Ctr |
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| Los Angeles, California, United States, 90033 |
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| UCSF - San Francisco Gen Hosp |
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| San Francisco, California, United States, 94110 |
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| Infectious Disease Med Group |
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| Oakland, California, United States, 94609 |
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| Georgetown Univ Med Ctr |
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| Washington, District of Columbia, United States, 20007 |
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| Infectious Disease Research Consortium of Georgia |
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| Atlanta, Georgia, United States, 30345 |
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| Johns Hopkins Hosp |
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| Baltimore, Maryland, United States, 21205 |
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| Harlem Hosp Ctr |
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| New York, New York, United States, 10037 |
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| Saint Vincent's Hosp and Med Ctr |
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| New York, New York, United States, 10011 |
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| Beth Israel Med Ctr |
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| New York, New York, United States, 10003 |
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| SUNY / Health Sciences Ctr at Stony Brook |
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| Stony Brook, New York, United States, 117948153 |
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| Duke Univ Med Ctr |
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| Durham, North Carolina, United States, 27710 |
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| Portland Veterans Adm Med Ctr / Rsch & Education Grp |
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| Portland, Oregon, United States, 97210 |
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| Regional Med Ctr at Memphis |
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| Memphis, Tennessee, United States, 38103 |
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| Gathe, Joseph, M.D. |
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| Houston, Texas, United States, 77004 |
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| Baylor College of Medicine |
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| Houston, Texas, United States, 77030 |
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| Infectious Disease Physicians Inc |
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| Annandale, Virginia, United States, 22203 |
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| Southern Alberta HIV Clinic / Foothills Hosp |
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| Calgary, Alberta, Canada |
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| Dr Julio S G Montaner |
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| Vancouver, British Columbia, Canada |
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| Wellesley Hosp |
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| Toronto, Ontario, Canada |
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| Dr Emil Toma / Hotel Dieu de Montreal |
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| Montreal, Quebec, Canada |
Publications:
| Masur H, et al. 566C80 is effective as salvage treatment for toxoplasma encephalitis. Int Conf AIDS. 1991 Jun 16-21;7(2):30 (abstract no WB31) |
| Study ID Numbers: |
101A, 02 |
| First Received: |
November 2, 1999 |
| Last Updated: |
June 23, 2005 |
| ClinicalTrials.gov Identifier: |
NCT00001994 |
| Health Authority: |
United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
| Toxoplasmosis |
| AIDS-Related Opportunistic Infections |
| Naphthoquinones |
| Encephalitis |
| Acquired Immunodeficiency Syndrome | |
Study placed in the following topic categories:
| Pyrimethamine |
| Bacterial Infections |
| Protozoan Infections |
| Opportunistic Infections |
| Sexually Transmitted Diseases, Viral |
| Toxoplasmosis, Cerebral |
| Acquired Immunodeficiency Syndrome |
| Central Nervous System Diseases |
| Brain Diseases |
| Encephalitis | |
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| Toxoplasmosis |
| Immunologic Deficiency Syndromes |
| Folic Acid |
| Mycoses |
| Atovaquone |
| Central Nervous System Infections |
| HIV Infections |
| Abscess |
| AIDS-Related Opportunistic Infections |
| Sexually Transmitted Diseases | |
Additional relevant MeSH terms:
| Brain Abscess |
| Abscess |
| Anti-Infective Agents |
| Antiprotozoal Agents |
| Slow Virus Diseases |
| Molecular Mechanisms of Pharmacological Action |
| Central Nervous System Viral Diseases |
| Infection |
| Central Nervous System Parasitic Infections |
| Antimalarials | |
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| Antiparasitic Agents |
| Therapeutic Uses |
| Parasitic Diseases |
| Coccidiostats |
| RNA Virus Infections |
| Immune System Diseases |
| Coccidiosis |
| Nervous System Diseases |
| Enzyme Inhibitors |
| Folic Acid Antagonists | | Source: National Library of Medicine (NLM) June 26, 2008
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