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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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 | Intervention | Phase |
---|---|---|
Pneumonia, Pneumocystis Carinii HIV Infections |
Drug: Pentamidine isethionate Drug: Sulfamethoxazole-Trimethoprim |
Phase 3 |
Study Type: | Interventional |
Study Design: | 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 |
Estimated Enrollment: | 240 |
Study Completion Date: | September 1991 |
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.
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
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 |
Study Chair: | B Montgomery |
Additional 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 |
Study First Received: | November 2, 1999 |
Last Updated: | March 28, 2012 |
Health Authority: | United States: Federal Government |
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 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 Trimethoprim Trimethoprim-Sulfamethoxazole Combination Sulfamethoxazole Antifungal Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antiprotozoal Agents Antiparasitic Agents Trypanocidal Agents |
ClinicalTrials.gov processed this record on March 14, 2013