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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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ClinicalTrials.gov Identifier: NCT00000715
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : March 29, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Pneumonia, Pneumocystis Carinii HIV Infections Drug: Pentamidine isethionate Drug: Sulfamethoxazole-Trimethoprim Phase 3

Detailed Description:

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: A Controlled Trial Comparing the Efficacy of Aerosolized Pentamidine and Parenteral/Oral Trimethoprim-Sulfamethoxazole in the Treatment of Pneumocystis Pneumonia in AIDS
Study Completion Date : September 1991


Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000715


Locations
United States, Louisiana
Tulane Univ School of Medicine
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, United States, 02114
United States, New York
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx, New York, United States, 10461
Mount Sinai Med Ctr
New York, New York, United States, 10029
Univ of Rochester Medical Center
Rochester, New York, United States, 14642
United States, North Carolina
Univ of North Carolina
Chapel Hill, North Carolina, United States, 275997215
United States, Ohio
Holmes Hosp / Univ of Cincinnati Med Ctr
Cincinnati, Ohio, United States, 452670405
Univ Hosp of Cleveland / Case Western Reserve Univ
Cleveland, Ohio, United States, 44106
United States, South Carolina
Julio Arroyo
West Columbia, South Carolina, United States, 29169
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Study Chair: B Montgomery
More Information

Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000715     History of Changes
Other Study ID Numbers: ACTG 040
11015 ( Registry Identifier: DAIDS ES Registry Number )
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: March 29, 2012
Last Verified: March 2012

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Trimethoprim-Sulfamethoxazole Combination
AIDS-Related Opportunistic Infections
Pneumonia, Pneumocystis carinii
Pentamidine
Infusions, Intravenous
Administration, Inhalation
Aerosols
Acquired Immunodeficiency Syndrome
Sulfamethoxazole-Trimethoprim

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