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NCT00000727 · ClinicalTrials.gov registry record · Phase 3
A Controlled Comparative Trial of Sulfamethoxazole-Trimethoprim Versus Aerosolized Pentamidine for Secondary Prophylaxis of Pneumocystis Carinii Pneumonia in AIDS Patients Receiving Azidothymidine (AZT)
A Phase 3 study of HIV Infections and Pneumonia, Pneumocystis Carinii, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 3
- Development phase
- 322
- Enrollment target
- 9
- Study locations
NCT00000727 is a Phase 3 study of HIV Infections and Pneumonia, Pneumocystis Carinii that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 322 participants, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (28% lower). The trial reports 9 study locations across 7 states.
The verdict
NCT00000727, a Phase 3 study of HIV Infections and Pneumonia, Pneumocystis Carinii, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 322 participants
- Enrollment target
- 9
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Zidovudine
- DRUG Pyrimethamine
- DRUG Pentamidine isethionate
- DRUG Sulfamethoxazole/Trimethoprim
- DRUG Sulfadoxine/Pyrimethamine
Study Locations (9)
California
- USC CRS - Los Angeles
- Ucsd, Avrc Crs - San Diego
- Ucsf Aids Crs - San Francisco
Indiana
- Indiana Univ. School of Medicine, Infectious Disease Research Clinic - Indianapolis
Massachusetts
- Bmc Actg Crs - Boston
Minnesota
- University of Minnesota, ACTU - Minneapolis
New York
- Memorial Sloan-Kettering Cancer Ctr. - New York
Ohio
- Case CRS - Cleveland
Washington
- University of Washington AIDS CRS - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 322 participants |
| Est. Completion | 1991-08 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000727
The ClinicalTrials.gov registry entry for NCT00000727 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 322 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (28% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 5 interventions - of which Zidovudine is the first listed.
NCT00000727 reports 9 study locations spanning 7 distinct geographic areas - top geographies include California, Indiana, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT00000727 about?
NCT00000727 is a clinical study titled "A Controlled Comparative Trial of Sulfamethoxazole-Trimethoprim Versus Aerosolized Pentamidine for Secondary Prophylaxis of Pneumocystis Carinii Pneumonia in AIDS Patients Receiving Azidothymidine (AZT)". 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 episod...
What is the current status of trial NCT00000727?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 322 participants. Estimated completion is 1991-08.
What conditions does trial NCT00000727 study?
This clinical trial studies the following conditions: HIV Infections, Pneumonia, Pneumocystis Carinii.
What interventions are being tested in trial NCT00000727?
The interventions under investigation include: Zidovudine (DRUG), Pyrimethamine (DRUG), Pentamidine isethionate (DRUG), Sulfamethoxazole/Trimethoprim (DRUG), Sulfadoxine/Pyrimethamine (DRUG).
Who is sponsoring clinical trial NCT00000727?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00000727 being conducted?
This trial has 9 study locations across California, Indiana, Massachusetts, Minnesota, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.