Clinical trial NCT00001994: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Toxoplasmosis, Cerebral
HIV Infections
Keywords: Toxoplasmosis
AIDS-Related Opportunistic Infections
Naphthoquinones
Encephalitis
Acquired Immunodeficiency Syndrome
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Los Angeles County - USC Med Ctr
state: California
city: Oakland
country: United States
facility: Infectious Disease Med Group
state: California
city: San Francisco
country: United States
facility: San Francisco Gen Hosp
state: California
city: San Francisco
country: United States
facility: UCSF - San Francisco Gen Hosp
state: California
city: San Francisco
country: United States
facility: Davies Med Ctr
state: California
city: Washington
country: United States
facility: Georgetown Univ Med Ctr
state: District of Columbia
city: Atlanta
country: United States
facility: Infectious Disease Research Consortium of Georgia
state: Georgia
city: Baltimore
country: United States
facility: Johns Hopkins Hosp
state: Maryland
city: New York
country: United States
facility: Beth Israel Med Ctr
state: New York
city: New York
country: United States
facility: Saint Vincent's Hosp and Med Ctr
state: New York
city: New York
country: United States
facility: Harlem Hosp Ctr
state: New York
city: Stony Brook
country: United States
facility: SUNY / Health Sciences Ctr at Stony Brook
state: New York
city: Durham
country: United States
facility: Duke Univ Med Ctr
state: North Carolina
city: Portland
country: United States
facility: Portland Veterans Adm Med Ctr / Rsch & Education Grp
state: Oregon
city: Memphis
country: United States
facility: Regional Med Ctr at Memphis
state: Tennessee
city: Houston
country: United States
facility: Gathe, Joseph, M.D.
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Annandale
country: United States
facility: Infectious Disease Physicians Inc
state: Virginia
city: Calgary
country: Canada
facility: Southern Alberta HIV Clinic / Foothills Hosp
state: Alberta
city: Vancouver
country: Canada
facility: Dr Julio S G Montaner
state: British Columbia
city: Toronto
country: Canada
facility: Wellesley Hosp
state: Ontario
city: Montreal
country: Canada
facility: Dr Emil Toma / Hotel Dieu de Montreal
state: Quebec
Study officials:
References:
citation: 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)