A Controlled Trial Comparing the Efficacy of Aerosolized Pentamidine and Parenteral / Oral Trimethoprim - Sulfamethoxazole in the Treatment of Pneumocystis Carinii Pneumonia in AIDS

Study Description

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Brief Summary:

This is a randomized double-blinded controlled study comparing aerosolized pentamidine with trimethoprim plus sulfamethoxazole (TMP / PurposeX). The latter drug will be administered intravenously for at least 5 days, then changed to oral administration if warranted by the patient's clinical condition.

Condition or disease	Intervention/treatment	Phase
Pneumonia, Pneumocystis Carinii; HIV Infections	Drug: Pentamidine isethionate	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Masking:	Double
Primary Purpose:	Treatment
Official Title:	A Controlled Trial Comparing the Efficacy of Aerosolized Pentamidine and Parenteral / Oral Trimethoprim - Sulfamethoxazole in the Treatment of Pneumocystis Carinii Pneumonia in AIDS

Arms and Interventions

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Outcome Measures

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Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

• Zidovudine as long as such therapy is suspended prior to randomization and not reinstituted until therapy for the acute episode is completed.

Pneumocystis carinii pneumonia (PCP) in an adult who is HIV positive by ELISA, HIV culture, or p24 antigenemia, or is a member of a risk group for HIV infection (homosexual or bisexual men, intravenous drug abusers, recipients of HIV infected blood products, and the sexual partners of the foregoing groups).

• The patient must have a resting Alveolar - arterial oxygen (A-a) DO2 less than 30 mmHg on room air at all ACTG sites, except San Francisco General Hospital. Other sites will enter patients up to a resting (A-a) DO2 = or < 55 mmHg on room air.

Prior Medication:

Allowed:

• Zidovudine as long as such therapy is suspended prior to randomization and not reinstituted until therapy for the acute episode is completed.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

• Dyspnea.
• Cough.
• Bronchospasm.
• History of a major adverse reaction to pentamidine or sulfonamide containing preparations.

Patients with the following will be excluded:

• Inability to cooperate with aerosol administration because of dyspnea, cough, bronchospasm, or other reasons.
• History of a major adverse reaction to pentamidine or sulfonamide containing preparations.
• In the opinion of the investigator, the patient would not complete therapy or follow-up for social reasons.

Prior Medication:

Excluded within 14 days of study entry:

• Systemic steroids above adrenal replacement doses.
• Excluded within 6 weeks of study entry:
• Other antiprotozoal regimen for this episode such as trimethoprim / sulfamethoxazole (TMP / PurposeX).
• Pyrimethamine.
• Fansidar.
• Pentamidine.
• Eflornithine (DFMO).
• Dapsone, whether therapeutic or prophylactic, or any of these agents.

Contacts and Locations

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Locations

United States, Illinois
LyphoMed Inc
Rosemont, Illinois, United States, 60018

Sponsors and Collaborators

LyphoMed

More Information

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Publications:

Montgomery AB, Edison RE, Sattler F, Hopewell P, Mason G, Feigal DW. Aerosolized pentamidine vs. trimethoprim/sulfamethoxazole for acute Pneumcoystis carinii pneumonia (PCP): a randomized double blind trial. Int Conf AIDS. 1990 Jun 20-23;6(1):220 (abstract no ThB395)

ClinicalTrials.gov Identifier:	NCT00002056 History of Changes
Other Study ID Numbers:	023A; 87-001
First Posted:	August 31, 2001
Last Update Posted:	June 24, 2005
Last Verified:	August 1989

Keywords provided by NIH AIDS Clinical Trials Information Service:

Trimethoprim-Sulfamethoxazole Combination; AIDS-Related Opportunistic Infections; Pneumonia, Pneumocystis carinii; Pentamidine	Injections, Intravenous; Administration, Oral; Aerosols; Acquired Immunodeficiency Syndrome

Additional relevant MeSH terms:

HIV Infections; 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; Lung Diseases; Respiratory Tract Diseases; Respiratory Tract Infections; Lung Diseases, Fungal	Mycoses; Pneumocystis Infections; Trimethoprim; Trimethoprim, Sulfamethoxazole Drug Combination; Sulfamethoxazole; Pentamidine; Anti-Infective Agents, Urinary; Anti-Infective Agents; Renal Agents; Antimalarials; Antiprotozoal Agents; Antiparasitic Agents; Folic Acid Antagonists; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action