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.

First Received on November 2, 1999. Last Updated on June 23, 2005 History of Changes

Sponsor:	Fisons
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002054

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.

Condition	Intervention
Pneumonia, Pneumocystis Carinii HIV Infections	Drug: Pentamidine isethionate

Study Type:	Interventional
Study Design:	Masking: Double-Blind Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS Pneumonia

Drug Information available for: Pentamidine Pentamidine isetionate

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002054

Locations

United States, New York
Fisons Corp
Rochester, New York, United States, 14603

Sponsors and Collaborators

Fisons

More Information

Publications:

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. 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)

ClinicalTrials.gov Identifier:	NCT00002054 History of Changes
Other Study ID Numbers:	022C, 87-71 (Part C)
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

AIDS-Related Opportunistic Infections
Pneumonia, Pneumocystis carinii
Pentamidine
Dose-Response Relationship, Drug
Acquired Immunodeficiency Syndrome

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Pneumonia
Pneumonia, Pneumocystis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Lung Diseases

Respiratory Tract Diseases
Respiratory Tract Infections
Lung Diseases, Fungal
Mycoses
Pneumocystis Infections
Pentamidine
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antiprotozoal Agents
Antiparasitic Agents
Trypanocidal Agents

ClinicalTrials.gov processed this record on February 12, 2012