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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002054
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
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No Changes Posted
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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
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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Interventional
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Masking: Double
Primary Purpose: Treatment
  • Pneumonia, Pneumocystis Carinii
  • HIV Infections
Drug: Pentamidine isethionate
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.

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
 
 
NCT00002054
022C
87-71 (Part C)
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Fisons
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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