A Double-Blind Group Comparative Study To Evaluate the Long-Term Safety and Effectiveness of Two Different Doses of Aerosol Pentamidine in the Prophylaxis of Pneumocystis Carinii Pneumonia in AIDS Patients With Multiple Episodes of PCP

NCT ID: NCT00002055

Last Updated: 2005-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL

Brief Summary

To evaluate and compare the safety, tolerability, and effectiveness of long-term biweekly administration of 1 of 2 doses of aerosol pentamidine when used as a prophylactic agent in patients who have had multiple episodes of AIDS associated Pneumocystis carinii pneumonia (PCP).

Conditions

Pneumonia, Pneumocystis Carinii; HIV Infections

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Pentamidine isethionate

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

• Zidovudine (AZT).

Patients must have:

• AIDS.
• Recovered from their most recent episode of Pneumocystis carinii pneumonia (PCP). Patients must be at least 2 weeks status post therapy for acute PCP.
• 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).
• Patients must be free of acute medical problems.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

• AIDS-defining opportunistic infection prior to entry such as toxoplasmosis and cryptococcosis.
• Pulmonary Kaposi's sarcoma.
• Asthma poorly controlled by medication.
• Receiving active therapy for tuberculosis.

Concurrent Medication:

Excluded:

• Active therapy for tuberculosis.

Patients with the following are excluded:

• Requiring ongoing active therapy for an opportunistic infection at time of study entry.
• AIDS-defining opportunistic infection prior to study entry such as toxoplasmosis and cryptococcosis.
• Pulmonary Kaposi's sarcoma.
• Unwilling to sign informed consent.
• Asthma poorly controlled by medication.
• Unwilling to cooperate with study procedures.
• Receiving active therapy for tuberculosis.

Prior Medication:

Excluded within 30 days of study entry:

• Antiretrovirals (other than zidovudine (AZT)).
• Immunomodulating agents.
• Corticosteroids.

Prior Treatment:

Excluded within 7 days of study entry:

• Transfusion.
• Patient cannot be transfusion dependent (requiring blood transfusion more than once per month).

Active substance abuse.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fisons

INDUSTRY

Sponsor Role: lead

Locations

Georgetown Univ

Washington D.C., District of Columbia, United States

Veterans Administration Med Ctr

Washington D.C., District of Columbia, United States

Northwestern Univ Med School

Chicago, Illinois, United States

Beth Israel Deaconess - West Campus

Boston, Massachusetts, United States

Countries

United States

References

Lavelle J, Murphy R, Harding P, Pierce P. Aerosolized pentamidine prophylaxis following Pneumocystis carinii pneumonia in patients with AIDS. Int Conf AIDS. 1990 Jun 20-23;6(2):374 (abstract no 2083)

Reference Type: BACKGROUND

Murphy RL, Lavelle JP, Allan JD, Gordin FM, Dupliss R, Boswell SL, Waskin HA, Davies SF, Graziano FM, Saag MS, et al. Aerosol pentamidine prophylaxis following Pneumocystis carinii pneumonia in AIDS patients: results of a blinded dose-comparison study using an ultrasonic nebulizer. Am J Med. 1991 Apr;90(4):418-26.

Reference Type: BACKGROUND

PMID: 2012082 (View on PubMed)

Other Identifiers

88-7

Identifier Type: -

Identifier Source: secondary_id

022D

Identifier Type: -

Identifier Source: org_study_id