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NCT00000816 · ClinicalTrials.gov registry record · Phase 4
Gradual Initiation of Sulfamethoxazole/Trimethoprim as Primary Pneumocystis Carinii Pneumonia Prophylaxis
A Phase 4 study of HIV Infections and Pneumonia, Pneumocystis Carinii, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 4
- Development phase
- 370
- Enrollment target
- 20
- Study locations
NCT00000816: Completed Phase 4 study of HIV Infections and Pneumonia, Pneumocystis Carinii, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00000816 is a Phase 4 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 370 participants, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (17% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00000816, a Phase 4 study of HIV Infections and Pneumonia, Pneumocystis Carinii, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 370 participants
- Enrollment target
- 20
- Study locations
Study Summary
To determine whether gradual initiation of sulfamethoxazole/trimethoprim (SMX/TMP) reduces the incidence of treatment-limiting adverse reactions compared to the routine initiation of the drugs for Pneumocystis carinii pneumonia (PCP) prophylaxis in HIV-infected patients. Although a number of clinical trials have demonstrated the superiority of SMX/TMP for PCP prophylaxis, the incidence of adverse reactions to this medication is high. In a pilot study in which patients were initiated with SMX/TMP prophylaxis by gradually increasing the dose over 2 weeks, no significant adverse reactions have occurred.
Conditions Studied
Interventions
- DRUG Sulfamethoxazole-Trimethoprim
Study Locations (20)
California
- USC CRS - Los Angeles
- Stanford CRS - Palo Alto
- Ucsf Aids Crs - San Francisco
- Santa Clara Valley Med. Ctr. - San Jose
- San Mateo County AIDS Program - San Mateo
- Harbor-UCLA Med. Ctr. CRS - Torrance
Illinois
- Northwestern University CRS - Chicago
- Cook County Hosp. CORE Ctr. - Chicago
- Rush Univ. Med. Ctr. ACTG CRS - Chicago
Florida
- Univ. of Florida Jacksonville NICHD CRS - Jacksonville
- Univ. of Miami AIDS CRS - Miami
Hawaii
- Queens Med. Ctr. - Honolulu
- Univ. of Hawaii at Manoa, Leahi Hosp. - Honolulu
Indiana
- Indiana Univ. School of Medicine, Infectious Disease Research Clinic - Indianapolis
- Methodist Hosp. of Indiana - Indianapolis
Massachusetts
- Massachusetts General Hospital ACTG CRS - Boston
- Bmc Actg Crs - Boston
Colorado
- University of Colorado Hospital CRS - Aurora
Louisiana
- Tulane/LSU Maternal/Child CRS - New Orleans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 370 participants |
| Est. Completion | 1996-09 |
| Phase | Phase 4 |
What the finished NCT00000816 record still lists
NCT00000816 is an interventional study that assigns participants to a tested intervention. The registered 370 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 (17% lower).
The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 1 intervention - of which Sulfamethoxazole-Trimethoprim is the first listed.
NCT00000816 names 20 study sites across 9 states, led by California, Illinois, Florida.
Frequently Asked Questions
What is clinical trial NCT00000816 about?
NCT00000816 is a clinical study titled "Gradual Initiation of Sulfamethoxazole/Trimethoprim as Primary Pneumocystis Carinii Pneumonia Prophylaxis". To determine whether gradual initiation of sulfamethoxazole/trimethoprim (SMX/TMP) reduces the incidence of treatment-limiting adverse reactions compared to the routine initiation of the drugs for Pneumocystis carinii pneumonia (PCP) prophylaxis in HIV-infected patients. Although a number of clinic...
What is the current status of trial NCT00000816?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 370 participants. Estimated completion is 1996-09.
What conditions does trial NCT00000816 study?
This clinical trial studies the following conditions: HIV Infections, Pneumonia, Pneumocystis Carinii.
What interventions are being tested in trial NCT00000816?
The interventions under investigation include: Sulfamethoxazole-Trimethoprim (DRUG).
Who is sponsoring clinical trial NCT00000816?
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 NCT00000816 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Hawaii, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00000816's enrollment target sits among peer trials
370 92nd of 542 higher than 451 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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