We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Safety and Effectiveness of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in Patients With AIDS Who Have Had PCP Before

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002291
First Posted: August 31, 2001
Last Update Posted: March 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NIH AIDS Clinical Trials Information Service
November 2, 1999
August 31, 2001
March 17, 2014
Not Provided
Not Provided
Not Provided
Not Provided
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
The Safety and Effectiveness of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in Patients With AIDS Who Have Had PCP Before
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
To evaluate and compare the safety, tolerability, and efficacy of biweekly administration of 1 of 3 doses of aerosol pentamidine when used as a prophylactic agent in patients who have recovered from their first episode of AIDS-associated Pneumocystis carinii pneumonia (PCP).
Not Provided
Interventional
Not Provided
Masking: Double
Primary Purpose: Treatment
  • Pneumonia, Pneumocystis Carinii
  • HIV Infections
Drug: Pentamidine isethionate
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
Not Provided
Not Provided

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Zidovudine (AZT).

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 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).
  • Asthma requiring medication.
  • 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 (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).
  • Unwilling to sign informed consent.
  • Cannot cooperate with study procedures.
  • Asthma requiring medication.

Prior Medication:

Excluded within 30 days of study entry:

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

Patients must:

  • Have AIDS and recovered from their first episode of cytologically or histologically proven Pneumocystis carinii pneumonia (PCP).
  • Be at least 2 weeks and no more than 24 weeks status post therapy for acute PCP.
  • Have positive antibody to HIV by any federally licensed ELISA test kit, or confirmed Western blot test.
  • Have adequate pulmonary function (vital capacity = or > 80 percent of predicted; forced expiratory volume (FEV), 1 s = or > 65 percent of total FEV; and corrected pulmonary diffusion capacity > 60 percent of predicted).
  • Free of acute medical problems.

Active substance abuse.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00002291
022A
87-71
Not Provided
Not Provided
Not Provided
Not Provided
Fisons
Not Provided
Not Provided
NIH AIDS Clinical Trials Information Service
October 1989

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP