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NCT00000715 · ClinicalTrials.gov registry record · Phase 3
A Controlled Trial Comparing the Efficacy of Aerosolized Pentamidine and Parenteral/Oral Sulfamethoxazole-Trimethoprim in the Treatment of Pneumocystis Carinii Pneumonia in AIDS
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
- 240
- Enrollment target
- 9
- Study locations
NCT00000715: Completed Phase 3 study of HIV Infections and Pneumonia, Pneumocystis Carinii, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00000715 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 240 participants, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (46% lower). The trial reports 9 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00000715, 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
- 240 participants
- Enrollment target
- 9
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Pentamidine isethionate
- DRUG Sulfamethoxazole-Trimethoprim
Study Locations (9)
New York
- Mount Sinai Med Ctr - New York
- Univ of Rochester Medical Center - Rochester
- Bronx Municipal Hosp Ctr/Jacobi Med Ctr - The Bronx
Ohio
- Holmes Hosp / Univ of Cincinnati Med Ctr - Cincinnati
- Univ Hosp of Cleveland / Case Western Reserve Univ - Cleveland
Louisiana
- Tulane Univ School of Medicine - New Orleans
Massachusetts
- Harvard (Massachusetts Gen Hosp) - Boston
North Carolina
- Univ of North Carolina - Chapel Hill
South Carolina
- Julio Arroyo - West Columbia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Est. Completion | 1991-09 |
| Phase | Phase 3 |
What the finished NCT00000715 record still lists
NCT00000715 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (46% lower).
The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 2 interventions - of which Pentamidine isethionate is the first listed.
NCT00000715 lists 9 locations in 6 states (New York, Ohio, Louisiana).
Frequently Asked Questions
What is clinical trial NCT00000715 about?
NCT00000715 is a clinical study titled "A Controlled Trial Comparing the Efficacy of Aerosolized Pentamidine and Parenteral/Oral Sulfamethoxazole-Trimethoprim in the Treatment of Pneumocystis Carinii Pneumonia in AIDS". 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...
What is the current status of trial NCT00000715?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 240 participants. Estimated completion is 1991-09.
What conditions does trial NCT00000715 study?
This clinical trial studies the following conditions: HIV Infections, Pneumonia, Pneumocystis Carinii.
What interventions are being tested in trial NCT00000715?
The interventions under investigation include: Pentamidine isethionate (DRUG), Sulfamethoxazole-Trimethoprim (DRUG).
Who is sponsoring clinical trial NCT00000715?
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 NCT00000715 being conducted?
This trial has 9 study locations across Louisiana, Massachusetts, New York, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT00000715's enrollment target sits among peer trials
240 150th of 542 higher than 391 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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