Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000758
The ClinicalTrials.gov registry entry for NCT00000758 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 158 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (65% 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 1 intervention - of which Fluorouracil is the first listed.
NCT00000758 reports 20 study locations spanning 13 distinct geographic areas - top geographies include 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
Similar trials for HIV Infections
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.
-
A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1
RECRUITING · Phase 3
-
Testing a Real-time Electronic Antiretroviral Adherence Monitoring Intervention
RECRUITING · Phase 3
-
SmartSteps: A Context-Aware, PrEP Adherence Intervention for Individuals With Substance Use Disorder
RECRUITING · Phase 3
-
Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current Antiretroviral Regimen in Virologically Suppressed HIV-1-infected Adults
ACTIVE NOT RECRUITING · Phase 3
-
A Study to Evaluate Efficacy, Safety and Tolerability in Antiretroviral Therapy (ART)-Experienced Participants of at Least 50 Years of Age Living With Human Immunodeficiency Virus (HIV) With Virologic Suppression Who Switch to DTG/3TC FDC From BIC/FTC/TAF
ACTIVE NOT RECRUITING · Phase 3
-
The LATITUDE Study: Long-Acting Therapy to Improve Treatment SUccess in Daily LifE
ACTIVE NOT RECRUITING · Phase 3
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
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.