Completed

Aerosol Pentamidine's Safety and Effectiveness in AIDS-Associated Pneumocystis Carinii Pneumonia Prophylaxis

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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
+16 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 people who have recovered from their first episode of Pneumocystis carinii pneumonia (PCP), a type of pneumonia commonly associated with AIDS. The main goal is to evaluate the safety, tolerability, and effectiveness of a medication called aerosol pentamidine. This drug is used as a preventive measure to help avoid future episodes of PCP in these patients. The study is important because it aims to find a safe and effective way to prevent PCP recurrence in AIDS patients, thereby improving their quality of life and overall health.

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

7 inclusion criteria required to participate
Allowed: Zidovudine (AZT). If AZT began prior to study entry, patients must have received = or > 15 days of AZT before beginning aerosol pentamidine

Allowed: Zidovudine (AZT). If AZT is started during the study, patients must have received = or > 15 days of aerosol pentamidine before beginning AZT

Patients must be at least 2 weeks and no more than 24 weeks status post therapy for acute PCP

Patients must be free of acute medical problems

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9 exclusion criteria prevent from participating
Patients requiring ongoing active therapy for an opportunistic infection (O.I.) at time of entry or those with either of the following AIDS-defining O.I.'s prior to entry: Toxoplasmosis, Cryptococcosis

Patients who are transfusion dependent (requiring blood transfusion more than once per month). The last transfusion cannot have been given within 7 days of study entry

Patients who have used antiretroviral agents other than zidovudine (AZT) within 30 days of study entry

Patients who have used corticosteroids within 30 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