Completed

Long-Term Safety and Effectiveness of Aerosol Pentamidine in AIDS-Associated PCP 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
+8 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 evaluating the safety and effectiveness of two different doses of aerosol pentamidine, a medication used to prevent Pneumocystis carinii pneumonia (PCP), a type of pneumonia common in AIDS patients. The study involves individuals who have previously experienced one episode of AIDS-associated PCP. The goal is to understand how well these patients can tolerate the medication and how long it takes for PCP to potentially develop again. This research is important as it aims to find the best dose for preventing PCP recurrence in AIDS patients, improving their quality of life and addressing a significant health challenge.

NCT00002054
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

2 inclusion criteria required to participate
Patients must receive the first dose on this study within 2 weeks of their last dose under study no. 87-71.
Patients who have completed 16 treatments under Fisons study no. 87-71 entitled, 'A Double-Blind Group Comparative Study To Evaluate the Safety and Effectiveness of Three Different Doses of Aerosol Pentamidine in the Prophylaxis of Pneumocystis Carinii Pneumonia in Patients With AIDS Post First Episode PCP.' Detailed safety parameters must have been documented for 6 months.
6 exclusion criteria prevent from participating
Active substance abuse.
Unwilling to sign informed consent.
Cannot cooperate with study procedures.
Asthma poorly controlled by medication.
Show More Criteria

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