Completed

Long-Term Safety and Effectiveness of Two Different Doses of Aerosol Pentamidine in AIDS Patients for 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
+18 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 AIDS patients who have experienced multiple episodes of a specific type of pneumonia called Pneumocystis Carinii Pneumonia (PCP). The main goal is to assess and compare the safety, tolerability, and effectiveness of two different doses of a medication called aerosol pentamidine. This medication is used as a preventive measure against future PCP episodes. The study is important as it aims to find a suitable dosage that can help manage this condition better and improve the quality of life for AIDS patients with recurrent PCP.

NCT00002055
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
Adequate pulmonary function (vital capacity = or > 65 percent of predicted; forced expiratory volume, 1 s = or > 55 percent of total FEV; and corrected pulmonary diffusion capacity > 50 percent of predicted).
Recovered from their most recent episode of Pneumocystis carinii pneumonia (PCP). Patients must be at least 2 weeks status post therapy for acute PCP.
Patients must be free of acute medical problems.
AIDS.
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13 exclusion criteria prevent from participating
Active substance abuse.
Unwilling to sign informed consent.
AIDS-defining opportunistic infection prior to entry such as toxoplasmosis and cryptococcosis.
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 4 locations

Georgetown Univ

Washington D.C., United StatesOpen Georgetown Univ in Google Maps

Veterans Administration Med Ctr

Washington D.C., United States

Northwestern Univ Med School

Chicago, United States

Beth Israel Deaconess - West Campus

Boston, United States
Completed4 Study Centers