MedTrace Logo

5-fluorouracil Following Cervical Intraepithelial Neoplasia Treatment Among HIV-positive Women in East Africa

NCT05362955 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-08-23

No results posted yet for this study

Summary

This is a single arm study on the safety, feasibility, and acceptability of adjuvant, self-administered, intravaginal 5-Fluorouracil (5-FU) following treatment for high-grade cervical precancer (CIN2/3) among women living with human immunodeficiency virus (HIV).

Conditions

  • CIN 2/3
  • HIV Infections

Interventions

DRUG

Intravaginal 5-Fluorouracil (5-FU)

Participants will self-administer 2 g of 5% 5-FU intravaginally using an applicator, one night per week (every other week), on weeks 1, 3, 5, 7, 9, 11, 13, 15, for a total of 8 applications.

Sponsors & Collaborators

  • UNC Lineberger Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Chemtai Mungo, MD, MPH · Assistant Professor, Obstetrics and Gynecology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-26
Primary Completion
2024-02-01
Completion
2024-02-01

Countries

  • Kenya

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05362955 on ClinicalTrials.gov