Completed

Long-Term Safety and Effectiveness of Aerosol Pentamidine in PCP Prophylaxis in AIDS Patients

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What is being tested

Pentamidine isethionate

Drug
Who is being recruted

Blood-Borne Infections+24

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
+19 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
See protocol details

Summary

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

This study focuses on the safety and effectiveness of a medication called aerosol pentamidine. The goal is to see how well this drug works in preventing a specific type of pneumonia, known as Pneumocystis Carinii Pneumonia (PCP), in patients diagnosed with AIDS. This research is important because it aims to find a reliable way to protect AIDS patients from recurring PCP, which can be a serious health threat.

NCT00002030
Principal SponsorFisons
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 18 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 DiseasesBacterial Infections and MycosesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsLung DiseasesLung Diseases, FungalMycosesOpportunistic InfectionsPneumoniaRespiratory Tract DiseasesRespiratory Tract InfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsPneumocystis InfectionsAcquired Immunodeficiency SyndromePneumonia, PneumocystisHIV InfectionsAIDS-Related Opportunistic Infections

Criteria

5 inclusion criteria required to participate
Concurrent medication allowed: Zidovudine (AZT)

Concurrent treatment allowed: Any standard or experimental treatment for an opportunistic infection or neoplasm that develops during the study

Patients must be free of acute medical problems

Patients must have AIDS with at least one cytologically or histologically proven episode of Pneumocystis carinii pneumonia (PCP)

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14 exclusion criteria prevent from participating
Patients receiving pentamidine by any route other than aerosolized or intravenous or any other experimental agent for chemoprophylaxis of PCP while on the study (e.g.: Septra, Fansidar, Dapsone, or eflornithine)

Patients requiring ongoing active therapy for an opportunistic infection at the time of study entry

Patients who are unwilling to sign informed consent

Patients who received a blood transfusion within 7 days 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 1 location

Fisons Corp

Rochester, United StatesOpen Fisons Corp in Google Maps
CompletedOne Study Center