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 - Tabular View

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00002054 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	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
Official Title ^ICMJE	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
Brief Summary	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.
Detailed Description
Study Phase
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Double-Blind
Condition ^ICMJE	Pneumonia, Pneumocystis Carinii HIV Infections
Intervention ^ICMJE	Drug: Pentamidine isethionate
Study Arms / Comparison Groups
Publications *	De Gruttola V, Wulfsohn M, Fischl MA, Tsiatis A. Modeling the relationship between survival and CD4 lymphocytes in patients with AIDS and AIDS-related complex. J Acquir Immune Defic Syndr. 1993 Apr;6(4):359-65.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00002054
Responsible Party
Study ID Numbers ^ICMJE	022C, 87-71 (Part C)
Study Sponsor ^ICMJE	Fisons
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	October 1989
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP