A Controlled Comparative Trial of Sulfamethoxazole-Trimethoprim Versus Aerosolized Pentamidine for Secondary Prophylaxis of Pneumocystis Carinii Pneumonia in AIDS Patients Receiving Azidothymidine (AZT)
2 other identifiers
interventional
322
1 country
9
Brief Summary
To determine if the drug combination sulfamethoxazole-trimethoprim (SMX-TMP), given by mouth, and the drug pentamidine (PEN), given by inhaled aerosol, are effective in preventing a relapse of Pneumocystis carinii pneumonia (PCP) when they are given to patients who have recovered from a first episode of PCP and are being given zidovudine (AZT) to treat primary HIV infection. AZT prolongs survival in patients with AIDS and decreases the occurrence of opportunistic infections such as PCP. However, PCP recurs in about 43 percent of patients receiving AZT, indicating a need for other treatments to reduce the relapse rate. The two medications to be tested in this study, SMX/TMP and aerosolized PEN, have also been partially effective in preventing recurrence of PCP. It is hoped that the combination of AZT with these medications will be more effective than AZT or one of the medications alone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
August 1, 1991
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedNovember 3, 2021
October 1, 2021
November 2, 1999
October 27, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients must fulfill the following criteria:
- Randomization within 10 weeks of completing therapy for Pneumocystis carinii pneumonia (PCP).
- Ability to tolerate oral and aerosolized therapy at the time of randomization.
- Life expectancy \> 4 months.
- Concurrent Medication:
- Allowed:
- Inhaled bronchodilators for cough and bronchospasm related to aerosolized pentamidine treatment.
- Aspirin at modest doses.
- Ibuprofen at modest doses.
- Acetaminophen at modest doses.
- Erythropoietin for management of anemia.
- Allowed to treat opportunistic infections while on study:
- Acyclovir.
- Ketoconazole.
- Amphotericin B.
- +14 more criteria
You may not qualify if:
- Active drug or alcohol abuse which would impair performance as a study subject.
- Concurrent Medication:
- Excluded:
- Famotidine.
- Any medications suspected of interference with the metabolism of zidovudine.
- Flurazepam.
- Chronic probenecid.
- Phenobarbital.
- Phenytoin.
- Experimental therapies, except as noted.
- Chronic oral bronchodilators should not be started in patients in order to maintain them on aerosolized pentamidine after they have exhibited pulmonary toxicity.
- Prior Medication:
- Excluded for the 30 patients who will undergo pharmacokinetic studies:
- Zidovudine (AZT) at any time.
- Excluded within 7 days of study entry for the 30 patients who will undergo pharmacokinetic studies:
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
USC CRS
Los Angeles, California, 90033, United States
Ucsd, Avrc Crs
San Diego, California, 92103, United States
Ucsf Aids Crs
San Francisco, California, 94110, United States
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, 46202, United States
Bmc Actg Crs
Boston, Massachusetts, 02118, United States
University of Minnesota, ACTU
Minneapolis, Minnesota, 55455, United States
Memorial Sloan-Kettering Cancer Ctr.
New York, New York, 10021, United States
Case CRS
Cleveland, Ohio, 44106, United States
University of Washington AIDS CRS
Seattle, Washington, 98105, United States
Related Publications (4)
Freedberg KA, Hardy WD, Holzman RS, Tosteson AN, Craven DE. Validating literature-based models with direct clinical trial results: the cost-effectiveness of secondary prophylaxis for PCP in AIDS patients. Med Decis Making. 1996 Jan-Mar;16(1):29-35. doi: 10.1177/0272989X9601600110.
PMID: 8717596BACKGROUNDHardy WD, Feinberg J, Finkelstein DM, Power ME, He W, Kaczka C, Frame PT, Holmes M, Waskin H, Fass RJ, et al. A controlled trial of trimethoprim-sulfamethoxazole or aerosolized pentamidine for secondary prophylaxis of Pneumocystis carinii pneumonia in patients with the acquired immunodeficiency syndrome. AIDS Clinical Trials Group Protocol 021. N Engl J Med. 1992 Dec 24;327(26):1842-8. doi: 10.1056/NEJM199212243272604.
PMID: 1448121BACKGROUNDHardy WD, Holzman RS, Avramis V, Bawdon R, Fall H, Feinberg J. Clinical and pharmacokinetic interactions of combined zidovudine (ZDV) therapy and sulfadoxine-pyrimethamine (fansidar) prophylaxis in post-PCP AIDS patients (ACTG 021). Int Conf AIDS. 1989 Jun 4-9;5:294 (abstract no TBP46)
BACKGROUNDRobins JM, Finkelstein DM. Correcting for noncompliance and dependent censoring in an AIDS Clinical Trial with inverse probability of censoring weighted (IPCW) log-rank tests. Biometrics. 2000 Sep;56(3):779-88. doi: 10.1111/j.0006-341x.2000.00779.x.
PMID: 10985216BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Holzman R
- STUDY CHAIR
Hardy WD
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
August 1, 1991
Last Updated
November 3, 2021
Record last verified: 2021-10