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
NCT ID: NCT00002054
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
DOUBLE
Interventions
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Pentamidine isethionate
Eligibility Criteria
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Inclusion Criteria
* Patients must receive the first dose on this study within 2 weeks of their last dose under study no. 87-71.
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Fisons
INDUSTRY
Locations
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Fisons Corp
Rochester, New York, United States
Countries
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References
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Hogan CH, Hodges JS, Mugglin A, Peterson PM, Abrams DI, Saravolatz L. The perils of visit-driven endpoints in antiretroviral trials. Int Conf AIDS. 1996 Jul 7-12;11(1):237 (abstract no TuB522)
Wulfsohn M, Fischl M, Tsiatis A. Predictors of survival among patients with AIDS receiving zidovudine. Int Conf AIDS. 1992 Jul 19-24;8(2):C314 (abstract no PoC 4419)
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 (1988). 1993 Apr;6(4):359-65.
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)
Other Identifiers
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87-71 (Part C)
Identifier Type: -
Identifier Source: secondary_id
022C
Identifier Type: -
Identifier Source: org_study_id