Clinical trial NCT00002055: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumonia, Pneumocystis Carinii
HIV Infections
Keywords: AIDS-Related Opportunistic Infections
Pneumonia, Pneumocystis carinii
Pentamidine
Dose-Response Relationship, Drug
Aerosols
Acquired Immunodeficiency Syndrome
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown Univ
state: District of Columbia
city: Washington
country: United States
facility: Veterans Administration Med Ctr
state: District of Columbia
city: Chicago
country: United States
facility: Northwestern Univ Med School
state: Illinois
city: Boston
country: United States
facility: Beth Israel Deaconess - West Campus
state: Massachusetts
Study officials:
References:
citation: 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)
citation: 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.