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NCT00000758 · ClinicalTrials.gov registry record · Phase 3
A Phase III Randomized Trial of Topical Vaginal Fluorouracil (5-Fluorouracil, 5-FU) Maintenance Therapy Versus Observation After Standard Treatment for High-Grade Cervical Dysplasia in HIV-Infected Women
A Phase 3 study of HIV Infections and Cervix, Dysplasia, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 3
- Development phase
- 158
- Enrollment target
- 20
- Study locations
NCT00000758: Completed Phase 3 study of HIV Infections and Cervix, Dysplasia, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00000758 is a Phase 3 study of HIV Infections and Cervix, Dysplasia that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 158 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (65% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00000758, a Phase 3 study of HIV Infections and Cervix, Dysplasia, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 158 participants
- Enrollment target
- 20
- Study locations
Study Summary
To determine the efficacy and safety of intravaginal fluorouracil administered as prophylaxis in HIV-infected women who have received standard ablative therapy (surgery) for high-grade cervical dysplasia (pre-cancer of the cervix; cervical intraepithelial neoplasia). To correlate time to recurrence of cervical dysplasia with T-cell function. Women with HIV infection are at greater risk for cervical dysplasia. Because of the likelihood that untreated or recurrent cervical dysplasia may progress to invasive cancer, there is an urgent need to develop appropriate therapies.
Conditions Studied
Interventions
- DRUG Fluorouracil
Study Locations (20)
New York
- SUNY - Buffalo, Erie County Medical Ctr. - Buffalo
- Memorial Sloan-Kettering Cancer Ctr. - New York
- Univ. of Rochester ACTG CRS - Rochester
- SUNY Upstate Med. Univ., Dept. of Peds. - Syracuse
- Bronx-Lebanon Hosp. IMPAACT CRS - The Bronx
Illinois
- Northwestern University CRS - Chicago
- Cook County Hosp. CORE Ctr. - Chicago
- Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease - Chicago
Massachusetts
- Bmc Actg Crs - Boston
- Beth Israel Deaconess Med. Ctr., ACTG CRS - Boston
California
- Usc La Nichd Crs - Los Angeles
Florida
- Univ. of Miami AIDS CRS - Miami
Louisiana
- Tulane/LSU Maternal/Child CRS - New Orleans
Maryland
- Johns Hopkins Adult AIDS CRS - Baltimore
Michigan
- Children's Hospital of Michigan NICHD CRS - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 158 participants |
| Est. Completion | 1998-04 |
| Phase | Phase 3 |
What the finished NCT00000758 record still lists
NCT00000758 is an interventional study that assigns participants to a tested intervention. The registered 158 participants enrollment target is mid-sized for trials with a published cap, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (65% lower).
The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 1 intervention - of which Fluorouracil is the first listed.
NCT00000758 names 20 study sites across 13 states, led by New York, Illinois, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT00000758 about?
NCT00000758 is a clinical study titled "A Phase III Randomized Trial of Topical Vaginal Fluorouracil (5-Fluorouracil, 5-FU) Maintenance Therapy Versus Observation After Standard Treatment for High-Grade Cervical Dysplasia in HIV-Infected Women". To determine the efficacy and safety of intravaginal fluorouracil administered as prophylaxis in HIV-infected women who have received standard ablative therapy (surgery) for high-grade cervical dysplasia (pre-cancer of the cervix; cervical intraepithelial neoplasia). To correlate time to recurrence ...
What is the current status of trial NCT00000758?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 158 participants. Estimated completion is 1998-04.
What conditions does trial NCT00000758 study?
This clinical trial studies the following conditions: HIV Infections, Cervix, Dysplasia.
What interventions are being tested in trial NCT00000758?
The interventions under investigation include: Fluorouracil (DRUG).
Who is sponsoring clinical trial NCT00000758?
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 NCT00000758 being conducted?
This trial has 20 study locations across California, Florida, Illinois, Louisiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00000758's enrollment target sits among peer trials
158 206th of 542 higher than 337 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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