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Completed

NCT Number: NCT05413811

Acceptability and Feasibility of Combination Treatment for Cervical Precancer Among South African Women Living With HIV

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.

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Key information

Conditions

Cervical Cancer Acquired Immunodeficiency Syndrome Blood-Borne Infections CIN2 CIN3 Communicable Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female HIV Infections Human Immunodeficiency Virus Human Papillomavirus Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Neoplasms Neoplasms by Site RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Virus Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Clinical HIV Research Unit Temba Lethu Wing Helen Joseph Hospital

Westdene, Johannesburg, 2092, South Africa

About this study

There are currently no medical therapies recommended to promote the clearance of humanpapilloma virus (HPV) infection, regression of cervical dysplasia, or treatment of cervical intraepithelial neoplasia (CIN). Human immunodeficiency virus (HIV) -infected women are at higher risk of HPV infection, with rates as high as 45% - 90%. Despite being preventable, cytologic abnormalities, cervical precancer (high-grade cervical intraepithelial neoplasia [CIN2/3]), and invasive cervical cancer also occur more frequently in HIV infected women.

This study is testing whether topical 5-fluorouracil (5FU) can be used as a patient-controlled adjuvant treatment for cervical precancer (CIN2/3) to be self-administered after surgical excision to reduce the risk of persistent/recurrent CIN2/3 and progression to cervical cancer among HIV-infected women.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

5 Fluorouracil (5 FU) Cream

Drug

Intravaginal topical chemotherapy, 5-fluorouracil cream

Other names: Fluoroplex, Efudex, Carac

Placebo

Drug

Intravaginal topical placebo cream

Primary outcomes

  1. The number of subjects adhered to and retained in the study

    Time frame: Up to 24 weeks

    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.

  2. The number of participants who found the intervention acceptable

    Time frame: week 10 to week 24

    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.

Secondary outcomes

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

    Time frame: 24 weeks

    Efficacy of combination treatment for CIN2/3 will be assessed as the number of subjects with CIN2 or CIN3 regressed to CIN1 or normal histology.

  2. The percentage of participants who demonstrate clearance of high-risk HPV

    Time frame: 24 weeks

    Efficacy of combination treatment for HPV will be assessed as the percentage of women in each study arm who demonstrate clearance of high-risk HPV between baseline and 24 weeks.

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Acronym: ACT2

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 10, 2022
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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