Toxoplasmic Encephalitis in Patients With AIDS. Treatment... | NCT00002064

Studies
Toxoplasmic Encephalitis in Patients With AIDS. Treatment and Prevention of Relapse

NCT00002064

Sponsor

Palo Alto Medical Foundation

Status

Completed

Last Update Posted

Jun 24, 2005Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Toxoplasmosis, Cerebral
HIV Infections

Interventions

Pyrimethamine
Clindamycin

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 1989

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Nov 2, 1999

First Submission Date that Met QC Criteria

Aug 30, 2001

First Posted Date

Aug 31, 2001Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2005

Last Update Posted Date

Jun 24, 2005Estimated

Description Module

Brief Summary

To compare pyrimethamine and intravenous (IV) clindamycin vs. pyrimethamine and sulfonamides in the treatment of AIDS patients with central nervous system (CNS) Toxoplasma gondii.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Eligibility Module

Eligibility Criteria

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions are excluded:

Opportunistic infection (Pneumocystis carinii pneumonia (PCP), cryptococcal meningitis) or other conditions (brain abscess) which would make treatment results difficult to interpret due to concurrent infection, disease, or therapy.

Patients with other opportunistic infections or brain diseases are excluded.

Patients with AIDS and cerebral toxoplasmosis.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Palo Alto Med Foundation		Palo Alto	California	94301	United States

Condition Browse Module

MeSH Terms

ID	Term
D016781	Toxoplasmosis, Cerebral
D015658	HIV Infections
D014123	Toxoplasmosis
D017088	AIDS-Related Opportunistic Infections
D004660	Encephalitis
D000163	Acquired Immunodeficiency Syndrome

Ancestor Terms

ID	Term
D001922	Brain Abscess
D002494	Central Nervous System Infections
D007239	Infections
D020808	Central Nervous System Protozoal Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011739	Pyrimethamine
D002981	Clindamycin

Ancestor Terms

ID	Term
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D008034	Lincomycin

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Pyrimethamine	Drug
Clindamycin	Drug