Completed

Diclazuril Capsules for Cryptosporidial Diarrhea in AIDS Patients

What is being tested

Diclazuril

Drug

Who is being recruted

Blood-Borne Infections+30

+ Urogenital Diseases

+ Genital Diseases

From 12 to 65 Years

+22 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

See protocol details

Summary

Principal SponsorJanssen, LP

Last updated: June 24, 2005

Sourced from a government-validated database.Claim as a partner

This study focuses on treating cryptosporidial related diarrhea in AIDS patients using a medication called diclazuril. Cryptosporidial related diarrhea is a common complication in AIDS patients, and this study aims to find a safe and effective treatment. The study involves patients who have previously participated in a double-blind study and have experienced a relapse, as well as those newly diagnosed with cryptosporidial related diarrhea who meet the study's criteria. The goal is to improve care for AIDS patients suffering from this condition. During the study, participants receive diclazuril in capsule form. The main objective is to evaluate the safety and effectiveness of diclazuril in treating cryptosporidial related diarrhea. The study measures the results by monitoring the reduction in diarrhea symptoms and any potential side effects. The potential benefits include a decrease in diarrhea symptoms, while possible risks may include side effects associated with diclazuril treatment.

NCT00002278

Principal SponsorJanssen, LP

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.

From 12 to 65 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

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesAnimal DiseasesCoccidiosisCommunicable DiseasesDigestive System DiseasesGastrointestinal DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsIntestinal DiseasesIntestinal Diseases, ParasiticOpportunistic InfectionsParasitic DiseasesParasitic Diseases, AnimalProtozoan InfectionsProtozoan Infections, AnimalRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSigns and SymptomsSigns and Symptoms, DigestiveSlow Virus DiseasesPathological Conditions, Signs and SymptomsVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAcquired Immunodeficiency SyndromeCryptosporidiosisDiarrheaHIV InfectionsAIDS-Related Opportunistic Infections

Criteria

9 inclusion criteria required to participate

Allowed: Aerosolized pentamidine

Allowed: Diclazuril

Allowed: Didanosine (ddI) allowed but discouraged, must have been stabilized on a constant dose for 3 weeks or more

Allowed: Ganciclovir therapy only for CMV retinitis is permitted if the patient has been treated for at least 4 weeks prior to study entry and is stable on the drug

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13 exclusion criteria prevent from participating

Excluded: Amphotericin B

Excluded: Antidiarrheal agents other than patients on long term loperamide prior to study entry

Excluded: Antifungal medications except nystatin

Excluded: Diclazuril within 2 weeks of study entry

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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 3 locations

Bellevue Hosp / New York Univ Med Ctr

New York, United StatesOpen Bellevue Hosp / New York Univ Med Ctr in Google Maps

Cornell Univ Med Ctr

New York, United States

Saint Luke's - Roosevelt Hosp Ctr

New York, United States

Completed3 Study Centers