NCT05413811

Brief Summary

The purpose of this study is to explore whether an anti-cancer medication (5-fluorouracil cream) placed in the vagina after a surgical excision procedure is an acceptable and useful form of treatment for cervical precancer among the woman with HIV infection.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 10, 2022

Completed
10 months until next milestone

Study Start

First participant enrolled

March 22, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

2.3 years

First QC Date

June 7, 2022

Last Update Submit

February 11, 2026

Conditions

Human Immunodeficiency VirusHuman PapillomavirusCervical CancerCIN2CIN3

Keywords

5-fluorouracil creamLoop electrosurgical excision

Outcome Measures

Primary Outcomes (2)

  • The number of subjects adhered to and retained in the study

    The feasibility of the combination of surgical excision followed by adjuvant 5FU for the treatment of CIN2/3 among HIV-infected women will be evaluated using the number of subjects adhered to and retained in the study.

    Up to 24 weeks

  • The number of participants who found the intervention acceptable

    The acceptability of the combination of surgical excision followed by adjuvant 5FU for the treatment of CIN2/3 among HIV-infected women will be assessed through a participant questionnaire administered at midline and end of the study.

    week 10 to week 24

Secondary Outcomes (2)

  • The proportion of participants with CIN2 or CIN 3 that regressed to CIN1

    24 weeks

  • The percentage of participants who demonstrate clearance of high-risk HPV

    24 weeks

Study Arms (2)

5 Fluorouracil Cream

EXPERIMENTAL

The participants will receive 8 doses of intravaginal 5 Fluorouracil Cream.

Drug: 5 Fluorouracil (5 FU) Cream

Placebo Cream

PLACEBO COMPARATOR

The participants will receive 8 doses of intravaginal placebo cream.

Drug: Placebo

Interventions

5 Fluorouracil (5 FU) CreamDRUG

Intravaginal topical chemotherapy, 5-fluorouracil cream

Also known as: Fluoroplex, Efudex, Carac
5 Fluorouracil Cream
PlaceboDRUG

Intravaginal topical placebo cream

Placebo Cream

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe target population is HIV-infected women only.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed HIV-1 infection
  • On antiretroviral therapy (ART), for at least 90 days prior to enrollment
  • Cervical biopsy demonstrating CIN2/3 within the preceding 120 days.

You may not qualify if:

  • pregnancy,
  • breastfeeding,
  • intend to become pregnant within 180 days of enrollment
  • have an active sexually transmitted infection (women may participate once treated)
  • have a surgically absent cervix
  • have a history of anogenital (cervical, vaginal, vulvar, or anal) cancer or a biopsy suspicious for cervical cancer
  • have a medical comorbidity that would interfere with study participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical HIV Research Unit Temba Lethu Wing Helen Joseph Hospital

Westdene, Johannesburg, 2092, South Africa

Location

Related Publications (4)

  • Teodoro NS, Mollan KR, Keys JR, Liu C, Mulongo M, Gumede S, Pasipamire T, Faesen M, Mischell MA, Rahangdale L, Chibwesha CJ. Acceptability and Feasibility of Combination Treatment for Cervical Precancer Among Women Living with HIV in South Africa: Primary Outcomes from the ACT 2 Randomized Trial. medRxiv [Preprint]. 2026 Mar 16:2026.03.14.26348308. doi: 10.64898/2026.03.14.26348308.

    PMID: 41891028DERIVED

  • Chibwesha CJ, Teodoro NS, Mollan KR, Keys JR, Liu C, Mulongo M, Gumede S, Pasipamire T, Faesen M, Rahangdale L. Efficacy of Combination Treatment for Cervical Precancer Among Women Living with HIV in South Africa: Secondary Outcomes from the ACT 2 Randomized Controlled Trial. medRxiv [Preprint]. 2026 Mar 22:2026.03.19.26348810. doi: 10.64898/2026.03.19.26348810.

    PMID: 41890998DERIVED

  • Chibwesha CJ, Mollan KR, Teodoro NS, Keys JR, Liu C, Mulongo M, Gumede S, Pasipamire T, Faesen M, Rahangdale L. Randomized clinical trial protocol: Acceptability and feasibility of combination treatment for cervical precancer among South African women living with HIV (ACT 2). Contemp Clin Trials. 2026 Mar 2:108272. doi: 10.1016/j.cct.2026.108272. Online ahead of print.

    PMID: 41780745DERIVED

  • Chibwesha CJ, Mollan KR, Teodoro NS, Keys JR, Liu C, Mulongo M, Gumede S, Pasipamire T, Faesen M, Rahangdale L. ACT 2 Clinical Trial Design: Acceptability and Feasibility of Combination Treatment for Cervical Precancer Among South African Women Living with HIV. medRxiv [Preprint]. 2025 Aug 14:2025.08.12.25333540. doi: 10.1101/2025.08.12.25333540.

    PMID: 40832398DERIVED

Related Links

MeSH Terms

Conditions

Uterine Cervical NeoplasmsAcquired Immunodeficiency Syndrome

Interventions

Fluorouracil

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

UracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Carla Chibwesha, MD, MSc

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2022

First Posted

June 10, 2022

Study Start

March 22, 2023

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

February 17, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

The rights and privacy of individuals who participate in research will be protected at all times. Thus, data intended for broader use will be stripped of identifiers that would permit linkages to individual research participants or variables that could lead to deductive disclosure of the identity of individual subjects. Research data that documents, supports and validates research findings will be made available after the main findings from the final research dataset have been accepted for publication. Such research data will be redacted to prevent the disclosure of personal identifiers. All data sharing will abide by rules and/or policies defined by the sponsor, relevant IRBs, U.S. local, state, and federal laws and regulations, as well as South African laws and regulations.

Locations

ZA(1)