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A Double-Blind Study To Evaluate the Long-Term Safety and Effectiveness of 60 mg Versus 120 mg of Aerosol Pentamidine in the Prophylaxis of Pneumocystis Carinii Pneumonia in AIDS Patients

A Double-Blind Study To Evaluate the Long-Term Safety and Effectiveness of 60 mg Versus 120 mg of Aerosol Pentamidine in the Prophylaxis of Pneumocystis Carinii Pneumonia in AIDS Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00002054
Enrollment
Unknown
Registered
2001-08-31
Start date
Unknown
Completion date
Unknown
Last updated
2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections, Pneumonia, Pneumocystis Carinii

Keywords

AIDS-Related Opportunistic Infections, Pneumonia, Pneumocystis carinii, Pentamidine, Dose-Response Relationship, Drug, Acquired Immunodeficiency Syndrome

Brief summary

To evaluate the safety, tolerability, and description of time to Pneumocystis carinii pneumonia (PCP) for long-term biweekly administration of 1 of 2 doses of aerosol pentamidine when used as a prophylactic agent in patients who have had one episode of AIDS-associated PCP.

Interventions

DRUGPentamidine isethionate

Sponsors

Fisons
Lead SponsorINDUSTRY

Study design

Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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. * Patients must receive the first dose on this study within 2 weeks of their last dose under study no. 87-71.

Exclusion criteria

Co-existing Condition: Patients with the following are excluded: * Requiring ongoing active therapy for an opportunistic infection (O.I.) at time of entry or those patients with either of the following AIDS-defining O.I.'s at entry: * Toxoplasmosis. * Cryptococcosis. * Pulmonary Kaposi's sarcoma. * Asthma poorly controlled by medication. * Receiving active therapy for tuberculosis. Patients with the following are excluded: * Requiring ongoing active therapy for an opportunistic infection (O.I.) at time of entry or those patients with either of the following AIDS-defining O.I.'s at entry: * Toxoplasmosis. * Cryptococcosis. * Pulmonary Kaposi's sarcoma. * Unwilling to sign informed consent. * Cannot cooperate with study procedures. * Asthma poorly controlled by medication. * Receiving active therapy for tuberculosis. Active substance abuse.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026