Expired Study
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Rochester, New York 14603


Purpose:

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.


Criteria:

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.


Study is Available At:


Original ID:

022C


NCT ID:

NCT00002054


Secondary ID:

87-71 (Part C)


Study Acronym:


Brief Title:

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 Pneumocyst


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

NIH AIDS Clinical Trials Information Service


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Masking: Double-Blind, Primary Purpose: Treatmen


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Study Dates

Verification Date:October 1989
Last Changed Date:June 23, 2005
First Received Date:November 2, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Pentamidine isethionate

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Fisons

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation: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)
Reference Type:Reference
Citation: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)
Reference Type:Reference
Citation: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.
PMID:8095980
Reference Type:Reference
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)

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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