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Completed

NCT Number: NCT05362955

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

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).

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Key information

Conditions

CIN 2/3 Blood-Borne Infections Communicable Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female HIV Infections 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 Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Virus Diseases

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Lumumba Sub-County Hospital KEMRI- Research Care Training Program (RCTP) Building

Kisumu, 614-40100, Kenya

Who can participate

Healthy volunteers accepted: Yes

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

Subjects must meet all of the inclusion criteria to participate in this study.

Inclusion criteria

  • HIV-positive women
  • Age 18 years - 49 years at enrollment
  • Documentation of a biopsy-confirmed CIN2 or CIN3
  • Within 4-12 weeks after primary treatment for CIN2 or CIN3
  • Negative pregnancy test at screening and agreement to use dual form of contraception (hormonal birth control, intrauterine device, or tubal ligation - plus condoms) during the study duration, if of childbearing age.
  • Agree to use dual contraception if of childbearing age (hormonal method, intrauterine or implant device, or tubal ligation - plus condoms) for duration of study
  • Ability to understand and willingness to sign (or assent when applicable) informed consent

Exclusion criteria

  • HIV-negative women
  • Pregnant or planning pregnancy within the next 6 months or breastfeeding
  • Unwilling or unable to use birth control during participation in the study
  • History of invasive cervical cancer
  • Untreated vaginal or vulvar dysplasia
  • Known allergy to 5-Fluorouracil
  • History of total hysterectomy
  • Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient
  • Current use of chemotherapeutic medication or high dose steroids (10 mg prednisone per day or more (or equivalent steroids)

Treatment and study plan

Intravaginal 5-Fluorouracil (5-FU)

Drug

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.

Primary outcomes

  1. Safety of intravaginal 5-FU

    Time frame: 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 outcomes

  1. Tolerability of intravaginal 5-FU

    Time frame: 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.

  2. Adherence of intravaginal 5-FU

    Time frame: 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.

  3. Acceptability of intravaginal 5-FU

    Time frame: 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.

  4. Uptake of intravaginal 5-FU

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 5, 2022
Registry last updated
Aug 23, 2024

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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