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

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.

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Key information

Conditions

Pneumonia, Pneumocystis Carinii AIDS-Related Opportunistic Infections Acquired Immunodeficiency Syndrome Bacterial Infections and Mycoses Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Lung Diseases Lung Diseases, Fungal Mycoses Opportunistic Infections Pneumocystis Infections Pneumonia Pneumonia, Pneumocystis RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fisons Corp

Rochester, New York, 14603, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pentamidine isethionate

Drug

Sponsors and collaborators

Lead sponsor

Fisons

Industry

Registry information

Important dates

First posted: Aug 31, 2001
Registry last updated: Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed