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 - Full Text View

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

MedlinePlus related topics:

AIDS Pneumonia

Drug Information available for:

Pentamidine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Double-Blind

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

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)

Study ID Numbers:	022C, 87-71 (Part C)
First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002054
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

Study placed in the following topic categories:

Opportunistic Infections

Sexually Transmitted Diseases, Viral

Clotrimazole

Pneumocystosis

Miconazole

Acquired Immunodeficiency Syndrome

Tioconazole

Immunologic Deficiency Syndromes

Virus Diseases

Mycoses

Pneumonia, Pneumocystis

Pneumocystis Infections

Respiratory Tract Infections

Respiratory Tract Diseases

HIV Infections

Lung Diseases

AIDS-Related Opportunistic Infections

Sexually Transmitted Diseases

Pentamidine

Retroviridae Infections

Pneumonia

Lung Diseases, Fungal

Additional relevant MeSH terms:

Trypanocidal Agents

Anti-Infective Agents

Antiparasitic Agents

Antiprotozoal Agents

RNA Virus Infections

Slow Virus Diseases

Immune System Diseases

Therapeutic Uses

Antifungal Agents

Lentivirus Infections

Infection

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2008

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