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Feasibility of Intravaginal Artesunate as Adjuvant HPV & Cervical Precancer Treatment in Kenya

NCT06519994 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-05-14

No results posted yet for this study

Summary

The objective of this randomized, placebo-controlled trial is to evaluate whether intravaginal artesunate pessaries (vaginal inserts) can be used as adjuvant therapy following thermal ablation to improve Human papillomavirus (HPV) treatment outcomes in Women Living with Human Immunodeficiency Virus (WLWH).

The study will evaluate whether women who use artesunate will have higher HPV clearance at 6 months, compared to those who used a placebo. The study will also assess the safety, adherence, and acceptability of this treatment. 120 participants will be enrolled in the study. Participants will self-administer the study drug nightly for 5 days, take a week off, and repeat twice (use study drug on weeks 1, 3,5) and will return to the clinic on weeks 2, 4, 6, 12, and week 24 for follow-up.

Conditions

  • Human Immunodeficiency Virus
  • Human Papillomavirus
  • Cervical Precancer

Interventions

DRUG

Artesunate vaginal inserts

Subjects will self-administer 200 mg of Artesunate vaginal insert daily for 5 days, on weeks 1, 3, 5.

DRUG

Placebo vaginal inserts

Subjects will self-administer a placebo vaginal insert daily for 5 days, on weeks 1, 3, 5.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Kenya Medical Research Institute

    collaborator OTHER

  • Maseno University School of Medicine, Kenya

    collaborator UNKNOWN

  • UNC Lineberger Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Chemtai Mungo, MD, MPH · UNC Lineberger Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-22
Primary Completion
2026-04-08
Completion
2026-04-08

Countries

  • Kenya

Study Locations

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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 NCT06519994 on ClinicalTrials.gov