Completed

Atovaquone for Central Nervous System Toxoplasmosis in AIDS Patients

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What is being tested

Atovaquone

Drug
Who is being recruted

Abscess+31

+ Blood-Borne Infections

+ Neuroinflammatory Diseases

Over 13 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
See protocol details

Summary

Principal SponsorGlaxo Wellcome
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

This study focuses on a treatment called 566C80, also known as atovaquone, for AIDS patients who have a specific type of brain infection called central nervous system (CNS) toxoplasmosis. The study is important because it aims to help patients who have not responded well to or cannot tolerate the usual treatments for this condition. The goal is to find a safer and more effective treatment option for these patients. During the study, participants receive atovaquone as part of their treatment. The study measures how well the patients tolerate this treatment and how safe it is for them. It also evaluates how effective atovaquone is in managing the acute phase of the infection and preventing it from recurring. The potential benefits include improved treatment and suppression of CNS toxoplasmosis in AIDS patients who have limited treatment options.

NCT00001994
Principal SponsorGlaxo Wellcome
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 13 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AbscessBlood-Borne InfectionsNeuroinflammatory DiseasesUrogenital DiseasesGenital DiseasesBrain AbscessBrain DiseasesCentral Nervous System DiseasesCentral Nervous System InfectionsCoccidiosisCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsNervous System DiseasesOpportunistic InfectionsParasitic DiseasesProtozoan InfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesSuppurationVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsCentral Nervous System Parasitic InfectionsCentral Nervous System Protozoal InfectionsAcquired Immunodeficiency SyndromeEncephalitisToxoplasmosisHIV InfectionsToxoplasmosis, CerebralAIDS-Related Opportunistic Infections

Criteria

6 inclusion criteria required to participate
Clindamycin-sulfonamide.
Pyrimethamine-sulfonamide.
Expected survival of at least four weeks without therapy.
Willing and able to give informed consent.
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6 exclusion criteria prevent from participating
First three weeks of treatment: Retrovir (zidovudine) or any investigational agent including antiretroviral agents (eg: ddI,ddC).
Drugs with potential anti-toxoplasmosis activity including sulfone, sulfonamide, trimethoprim, pyrimethamine and clindamycin during the acute therapy phase of the trial.
Evidence of significant malabsorption, ileus or significant emesis at entry which would inhibit drug absorption.
Significant emotional disorder or psychosis.
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Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 22 locations

Los Angeles County - USC Med Ctr

Los Angeles, United StatesOpen Los Angeles County - USC Med Ctr in Google Maps

Infectious Disease Med Group

Oakland, United States

San Francisco Gen Hosp

San Francisco, United States

UCSF - San Francisco Gen Hosp

San Francisco, United States
Completed22 Study Centers