Completed

Safety and Efficacy of Three Doses of Aerosol Pentamidine for AIDS-Associated 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
+17 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 patients who have recovered from their first episode of Pneumocystis carinii pneumonia (PCP), a lung infection commonly associated with AIDS. The main goal is to evaluate and compare the safety, tolerability, and effectiveness of three different doses of aerosol pentamidine. This drug is used as a preventive measure to help avoid future episodes of PCP in these patients. The study is important as it aims to find the most effective and safe dose of aerosol pentamidine for prophylaxis in patients with AIDS who have had PCP. During the study, participants receive one of three doses of aerosol pentamidine on a biweekly basis. The drug is administered through inhalation. The study measures the safety and effectiveness of each dose by monitoring the participants' health and checking for any signs of PCP recurrence. It also evaluates how well the participants tolerate the drug and any potential side effects. The study does not mention any specific risks or benefits associated with participation.

NCT00002291
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

6 inclusion criteria required to participate
Zidovudine (AZT).
Have adequate pulmonary function (vital capacity = or > 80 percent of predicted; forced expiratory volume (FEV), 1 s = or > 65 percent of total FEV; and corrected pulmonary diffusion capacity > 60 percent of predicted).
Free of acute medical problems.
Be at least 2 weeks and no more than 24 weeks status post therapy for acute PCP.
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11 exclusion criteria prevent from participating
Transfusion dependent (requiring blood transfusion more than once per month). The last transfusion cannot have been given within 7 days of study entry.
Asthma requiring medication.
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.
Pulmonary Kaposi's sarcoma (KS).
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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