Toxoplasmosis, CerebralNCT00001994
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
A study testing Atovaquone in people with Toxoplasmosis, Cerebral and HIV Infections, run by Glaxo Wellcome at 22 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Toxoplasmosis, Cerebral, HIV Infections
- What is being tested?
- Atovaquone
- How many people
- Not given
- Where
- 22 sitesin 2 countries
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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:
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- Allowed:
- Pyrimethamine-sulfonamide.
- Clindamycin-sulfonamide.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
22 sites in 2 countries.
22 sites in 2 countries
United States18 sites
Infectious Disease Physicians Inc
Annandale, Virginia, 22203
Infectious Disease Research Consortium of Georgia
Atlanta, Georgia, 30345
Johns Hopkins Hosp
Baltimore, Maryland, 21205
Duke Univ Med Ctr
Durham, North Carolina, 27710
Gathe, Joseph, M.D.
Houston, Texas, 77004
Baylor College of Medicine
Houston, Texas, 77030
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
Regional Med Ctr at Memphis
Memphis, Tennessee, 38103
Beth Israel Med Ctr
New York, New York, 10003
Saint Vincent's Hosp and Med Ctr
New York, New York, 10011
Harlem Hosp Ctr
New York, New York, 10037
Infectious Disease Med Group
Oakland, California, 94609
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, 97210
San Francisco Gen Hosp
San Francisco, California, 941102859
UCSF - San Francisco Gen Hosp
San Francisco, California, 94110
Davies Med Ctr
San Francisco, California, 94114
SUNY / Health Sciences Ctr at Stony Brook
Stony Brook, New York, 117948153
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
Canada4 sites
Southern Alberta HIV Clinic / Foothills Hosp
Calgary, Alberta
Dr Emil Toma / Hotel Dieu de Montreal
Montreal, Quebec
Wellesley Hosp
Toronto, Ontario
Dr Julio S G Montaner
Vancouver, British Columbia
About this study
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.
- Conditions
- Toxoplasmosis, Cerebral, HIV Infections
- Being tested
- Atovaquone
- Keywords
- Toxoplasmosis, AIDS-Related Opportunistic Infections, Naphthoquinones, Encephalitis, Acquired Immunodeficiency Syndrome
- Medical subject headings
- Toxoplasmosis, Cerebral, HIV Infections, Toxoplasmosis, AIDS-Related Opportunistic Infections, Encephalitis, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtovaquoneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Toxoplasmosis, CerebralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Glaxo Wellcome
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001994
- Sponsor's protocol ID
- 101A
- Other IDs
- 02
- Status last verified
- Mar 1992
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
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 at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00001994
- Acronym / sponsor ID
- 101A
- Conditions
- Toxoplasmosis, Cerebral, HIV Infections
- Keywords
- Toxoplasmosis, AIDS-Related Opportunistic Infections, Naphthoquinones, Encephalitis, Acquired Immunodeficiency Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Glaxo WellcomeIndustry (pharma, biotech, devices)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Presumptive diagnosis of AIDS.
- Cerebral toxoplasmosis.
- Expected survival of at least four weeks without therapy.
- Willing and able to give informed consent.
- Pyrimethamine-sulfonamide.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atovaquone | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
- BackgroundMasur 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)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atovaquone in people with Toxoplasmosis, Cerebral and HIV Infections, run by Glaxo Wellcome at 22 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001994, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.