Trial · NCT05362955
5-fluorouracil Following Cervical Intraepithelial Neoplasia Treatment Among HIV-positive Women in East Africa
NCT05362955, Phase 1, Completed, UNC Lineberger Comprehensive Cancer Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 5-fluorouracil Following Cervical Intraepithelial Neoplasia Treatment Among HIV-positive Women in East Africa. Trials, record NCT05362955. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05362955
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 5-fluorouracil Following Cervical Intraepithelial Neoplasia Treatment Among HIV-positive Women in East Africa
- NCT number
- NCT05362955
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 12 participants, actual
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Conditions
- CIN 2/3, HIV Infections
- Interventions
- Intravaginal 5-Fluorouracil (5-FU)
- First posted
- 2022-05-05
- Last updated
- 2024-08-23
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety of intravaginal 5-FU | Up to 5 months | Safety will be evaluated as type, frequency, and severity of Adverse Events (AE)s. AEs will be evaluated according to the National Institute of Health (NIH) Division of Acquired Immunodeficiency Syndrome (DAIDS) Adverse Event Grading Tables. The DAIDS grading table provides an AE severity grading scale ranging from grades 1 to 5. Grade 1 indicates a mild event, Grade 2 indicates a moderate event, Grade 3 indicates a severe event, Grade 4 indicates a potentially life-threatening event and Grade 5 indicates death. |
| Secondary | Tolerability of intravaginal 5-FU | Up to 5 months | Tolerability will be evaluated by assessing the number of participants experiencing specified adverse events (SAEs), defined as a Grade 3 or 4 toxicity that is possibly, probably, or definitely related to the study agent. |
| Secondary | Adherence of intravaginal 5-FU | Up to 5 months | Adherence will be evaluated by assessing the number of participants who are confirmed to use 75% or more of the 5-FU applications. |
| Secondary | Acceptability of intravaginal 5-FU | Up to 20 weeks | Responses to an acceptability questionnaire will be summarized, including means and standard deviation for responses to questions graded on a Likert scale (from 0 to 4), and proportions and 95% confidence intervals for yes/no questions. |
| Secondary | Uptake of intravaginal 5-FU | Up to 20 weeks | The proportion of eligible screened participants who agree to participate in the trial and applied intravaginal 5-FU as the study defined. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05362955
GET https://conductscience.org/api/trials/v1/NCT05362955/registered