A Double-Blind Placebo-Controlled Group Comparative Study To Evaluate the Safety and Effectiveness of Aerosol Pentamidine in the Prophylaxis of Pneumocystis Carinii Pneumonia in Patients With AIDS Post First Episode PCP

NCT00002053 | Completed

• 2 other identifiers: 022B87-72
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate and compare the safety, tolerability, and efficacy of biweekly administration of aerosol pentamidine versus placebo when used as a prophylactic agent in patients who have recovered from their first episode of AIDS-associated Pneumocystis carinii pneumonia (PCP).

Conditions

Pneumonia, Pneumocystis Carinii; HIV Infections

Keywords

AIDS-Related Opportunistic Infections; Pneumonia, Pneumocystis carinii; Pentamidine; Acquired Immunodeficiency Syndrome

Interventions

Pentamidine isethionate DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Concurrent Medication:
• Allowed:
• Zidovudine (AZT). If AZT is started during the study, patients must have received = or \> 15 days of aerosol pentamidine before beginning AZT.
• Prior Medication:
• Allowed:
• Zidovudine (AZT). If AZT began prior to study entry, patients must have received = or \> 15 days of AZT before beginning aerosol pentamidine.

You may not qualify if:

• 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 with either of the following AIDS-defining O.I.'s prior to entry:
• Toxoplasmosis.
• Cryptococcosis.
• Transfusion dependent (requiring blood transfusion more than once per month). The last transfusion cannot have been given within 7 days of study entry.
• Pulmonary Kaposi's sarcoma (KS).
• Uncontrolled asthma.
• 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 with either of the following AIDS-defining O.I.'s prior to entry:
• Toxoplasmosis.
• Cryptococcosis.
• Transfusion dependent (requiring blood transfusion more than once per month). The last transfusion cannot have been given within 7 days of study entry.
• Pulmonary Kaposi's sarcoma (KS).

Sponsors & Collaborators

• Fisons: lead

Study Sites (1)

Fisons Corp

Rochester, New York, 14603, United States

Location

Related Publications (1)

• Montaner JS, et al. Aerosolized pentamidine for the secondary prophylaxis of Pneumocystis carinii pneumonia in the acquired immunodeficiency syndrome: a report from the Canadian cooperative trial. Int Conf AIDS. 1989 Jun 4-9;5:295 (abstract no TBP54)

  BACKGROUND

MeSH Terms

Conditions

Pneumonia, Pneumocystis; HIV Infections; AIDS-Related Opportunistic Infections; Acquired Immunodeficiency Syndrome

Interventions

Pentamidine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Benzamidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Last Updated: June 24, 2005

Record last verified: 1989-10

Locations

US (1)