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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

Primary Purpose

Toxoplasmosis, Cerebral, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Atovaquone
Sponsored by
Glaxo Wellcome
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Toxoplasmosis, Cerebral focused on measuring Toxoplasmosis, AIDS-Related Opportunistic Infections, Naphthoquinones, Encephalitis, Acquired Immunodeficiency Syndrome

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Los Angeles County - USC Med Ctr
  • Infectious Disease Med Group
  • San Francisco Gen Hosp
  • UCSF - San Francisco Gen Hosp
  • Davies Med Ctr
  • Georgetown Univ Med Ctr
  • Infectious Disease Research Consortium of Georgia
  • Johns Hopkins Hosp
  • Beth Israel Med Ctr
  • Saint Vincent's Hosp and Med Ctr
  • Harlem Hosp Ctr
  • SUNY / Health Sciences Ctr at Stony Brook
  • Duke Univ Med Ctr
  • Portland Veterans Adm Med Ctr / Rsch & Education Grp
  • Regional Med Ctr at Memphis
  • Gathe, Joseph, M.D.
  • Baylor College of Medicine
  • Infectious Disease Physicians Inc
  • Southern Alberta HIV Clinic / Foothills Hosp
  • Dr Julio S G Montaner
  • Wellesley Hosp
  • Dr Emil Toma / Hotel Dieu de Montreal

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Glaxo Wellcome
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1. Study Identification

Unique Protocol Identification Number
NCT00001994
Brief 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
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

2. Study Status

Record Verification Date
March 1992
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Glaxo Wellcome

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Toxoplasmosis, Cerebral, HIV Infections
Keywords
Toxoplasmosis, AIDS-Related Opportunistic Infections, Naphthoquinones, Encephalitis, Acquired Immunodeficiency Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Atovaquone

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Los Angeles County - USC Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Infectious Disease Med Group
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
San Francisco Gen Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
941102859
Country
United States
Facility Name
UCSF - San Francisco Gen Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Davies Med Ctr
City
San Francisco
State/Province
California
ZIP/Postal Code
94114
Country
United States
Facility Name
Georgetown Univ Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Infectious Disease Research Consortium of Georgia
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30345
Country
United States
Facility Name
Johns Hopkins Hosp
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Beth Israel Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Saint Vincent's Hosp and Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Harlem Hosp Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10037
Country
United States
Facility Name
SUNY / Health Sciences Ctr at Stony Brook
City
Stony Brook
State/Province
New York
ZIP/Postal Code
117948153
Country
United States
Facility Name
Duke Univ Med Ctr
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Portland Veterans Adm Med Ctr / Rsch & Education Grp
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Regional Med Ctr at Memphis
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Facility Name
Gathe, Joseph, M.D.
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Infectious Disease Physicians Inc
City
Annandale
State/Province
Virginia
ZIP/Postal Code
22203
Country
United States
Facility Name
Southern Alberta HIV Clinic / Foothills Hosp
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Dr Julio S G Montaner
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Wellesley Hosp
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Dr Emil Toma / Hotel Dieu de Montreal
City
Montreal
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

Citations:
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)
Results Reference
background

Learn more about this trial

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

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