Completed

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

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What is being tested

Pentamidine isethionate

+ Sulfamethoxazole-Trimethoprim
Drug
Who is being recruted

Pneumonia, Pneumocystis Carinii

+ HIV Infections
Over 12 Years
How is the trial designed

Treatment Study

Phase 3
Interventional

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 3, 2021
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To compare the safety and effectiveness of drug therapy with aerosolized pentamidine (PEN) with that of conventional therapy, sulfamethoxazole plus trimethoprim (SMX/TMP) in the treatment of Pneumocystis carinii pneumonia (PCP) in patients who have AIDS, are HIV positive, or are at high risk for HIV infection. New treatments are needed for PCP, a common lung infection in patients with AIDS, because many patients treated with the two standard treatments, PEN given by injections and SMX/TMP, have had adverse effects that required a change in treatment. There is also a high relapse rate after the standard treatments. Preliminary experiments in humans suggest that aerosolized PEN is as effective as the standard treatments for PCP, and causes few adverse effects. New treatments are needed for PCP, a common lung infection in patients with AIDS, because many patients treated with the two standard treatments, PEN given by injections and SMX/TMP, have had adverse effects that required a change in treatment. There is also a high relapse rate after the standard treatments. Preliminary experiments in humans suggest that aerosolized PEN is as effective as the standard treatments for PCP, and causes few adverse effects. Patients entered in the study are randomly assigned to aerosolized PEN or to intravenous SMX/TMP, for a 21-day trial. SMX/TMP is given 4 times a day and aerosolized PEN once a day. Doses are determined by body size. Patients who receive aerosolized PEN also receive a placebo intravenous injection and patients who receive SMX/TMP also receive a placebo aerosol. Patients are hospitalized at least 5 days. Patients who improve may be discharged after 5 days at the discretion of the attending physician. Discharged patients continue the study with oral SMX/TMP and aerosolized placebo or aerosolized PEN and oral placebo. Patients who fail to respond or who develop severe adverse effects are switched to intravenous PEN or other standard therapy. During the 21-day trial, zidovudine (AZT) may not be used. AZT may be resumed after therapy for the acute PCP episode is completed.

Official TitleA Controlled Trial Comparing the Efficacy of Aerosolized Pentamidine and Parenteral/Oral Trimethoprim-Sulfamethoxazole in the Treatment of Pneumocystis Pneumonia in AIDS 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 3, 2021
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
240 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment
: Everyone gets the same treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 12 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Pneumonia, Pneumocystis Carinii
HIV Infections
Criteria

Inclusion Criteria Prior Medication: Allowed: * Zidovudine (AZT), but must be suspended during study medication. Unequivocal diagnosis of Pneumocystis carinii pneumonia established by morphologic confirmation of three or more typical Pneumocystis carinii organisms in sputum, bronchoalveolar lavage fluid, or lung tissue obtained by transbronchial or open-lung biopsy within 3 days before or after randomization. If morphologic confirmation is not possible prior to therapy, patients may be randomized if the investigator believes there is a high suspicion of PCP based on clinical presentation. If morphologic diagnosis cannot be established within 5 days of randomization, the patient will be withdrawn from study therapy. Resting (A-a) DO2 less than 30 torr on room air at all ACTG sites except San Francisco General Hospital. Non-ACTG sites will enter patients up to a resting (A-a) DO2less than 55 mmHg on room air. Exclusion Criteria Co-existing Condition: Patients with the following are excluded: * Dyspnea, cough, bronchospasm, or other reasons causing inability to cooperate with aerosol administration. * History of major adverse reaction to pentamidine or sulfonamide-containing preparation defined as: * Absolute neutropenia of 750 or less PMN + bands cells/mm3. * Thrombocytopenia below 40000 platelets/mm3. * Rise in creatinine: * To more than 3.0 mg/dl. * Liver function abnormalities: * SGOT or SGPT greater than 5 x upper limit of normal. * Hypoglycemia below 50 mg/dl. * Rash: * Exfoliative or mucositis. * Cough: * Unremitting or bronchospasm uncontrolled by bronchodilator preventing more than 50 percent of delivered dose for more than 2 days. Concurrent Medication: Excluded: * Other drugs for the treatment or prevention of AIDS or Pneumocystis carinii pneumonia. * Zidovudine (AZT). Patients with the following are excluded: * Dyspnea, cough, bronchospasm, or other reasons causing inability to cooperate with aerosol administration. * History of major adverse reaction to pentamidine or sulfonamide-containing preparation defined as: * Absolute neutropenia of 750 or less PMN + bands cells/mm3. * Thrombocytopenia lower than 40000 platelets/mm3. * Rise in creatinine: * To greater than 3.0 mg/dl. * Liver function abnormalities: * SGOT or SGPT greater than 5 x upper limit of normal. * Hypoglycemia less than 50 mg/dl. * Rash: * Exfoliative or mucositis. * Cough: * Unremitting or bronchospasm uncontrolled by bronchodilator preventing more than 50 percent of delivered dose for more than 2 days. Prior Medication: Excluded within 14 days of study entry: * Systemic steroids higher than adrenal replacement doses. * Excluded within 6 weeks of study entry: * Another antiprotozoal regimen for this episode, whether therapeutic or prophylactic. * Sulfamethoxazole / trimethoprim. * Pyrimethamine. * Sulfadoxine / pyrimethamine. * Pentamidine. * Eflornithine.



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 9 locations
Suspended
Tulane Univ School of MedicineNew Orleans, United StatesSee the location
Suspended
Harvard (Massachusetts Gen Hosp)Boston, United States
Suspended
Bronx Municipal Hosp Ctr/Jacobi Med CtrBronx, United States
Suspended
Mount Sinai Med CtrNew York, United States

Completed9 Study Centers