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

NCT06519994 | Completed Phase 2 DMC

• 2 other identifiers: LCCC2330R34CA284983
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

intravaginal; self-administer; artesunate; intravaginal artesunate; vaginal pessaries

Outcome Measures

Primary Outcomes (1)

• Clearance of type-specific HPV genotype(s)

  The number and proportion of women in each study arm who demonstrate clearance of the specific HPV genotype, or genotypes (if multiple) between baseline and six months will be reported.

  24 weeks

Secondary Outcomes (2)

• Adherence

  Week 6

• Acceptability measured by acceptability questionnaire

  Week 6

Other Outcomes (3)

• Uptake

  Baseline

• Accrual rate

  24 weeks

• Retention rate

  24 weeks

Study Arms (2)

Artesunate vaginal inserts

EXPERIMENTAL

Participants will self-administer the study drug nightly for 5 days, take a week off, and repeat 2 times (study drug application on weeks 1, 3, 5).

Drug: Artesunate vaginal inserts

Placebo vaginal inserts

PLACEBO COMPARATOR

Participants will self-administer the study placebo nightly for 5 days, take a week off, and repeat 2 times (study drug application on weeks 1, 3, 5).

Drug: Placebo vaginal inserts

Interventions

Artesunate vaginal inserts DRUG

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

Artesunate vaginal inserts

Placebo vaginal inserts DRUG

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

Placebo vaginal inserts

Eligibility Criteria

• Age: 25 Years+
• Gender Eligibility Details: Assigned biological female gender at birth.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 25 years or older
• Known HIV seropositive status
• On antiretroviral therapy for \> 90 days prior to enrollment
• Weight ≥50 Kg at study entry\*
• Positive HPV screening test and within 4-8 weeks of thermal ablation
• Ability to provide informed consent
• Planning to stay within the study locale during the duration of the study (24 weeks)
• Agreement to use contraception (barriers or hormonal) if of childbearing age through week 6 of the study

You may not qualify if:

• Current pregnancy or breastfeeding status
• Current or past history of invasive cervical cancer
• History of total hysterectomy
• Currently receiving systemic chemotherapy or radiation therapy for another cancer
• Current use of systemic immunosuppressants or steroids (\>10 mg of prednisone or equivalent)
• Current use of efavirenz antiretroviral therapy, phenytoin, carbamazepine, and rifampin
• Have medical comorbidity that, in the opinion of the investigator, would interfere with study participation
• Prior chemotherapy within 30 days prior to day 1 of study treatment
• Male at birth

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• Kenya Medical Research Institute: collaborator
• Maseno University School of Medicine, Kenya: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

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

Kisumu, 614-40100, Kenya

Location

Related Publications (1)

• Sadana A, Omoto J, Sorgi K, Rahangdale L, Smith JS, Plesa M, Mungo C. Feasibility of Intravaginal Artesunate as an Adjuvant HPV & Cervical Precancer Treatment Among Women Living With HIV in Kenya: Study Protocol for a Phase II Clinical Trial. Cancer Control. 2025 Jan-Dec;32:10732748251374418. doi: 10.1177/10732748251374418. Epub 2025 Sep 4.

  PMID: 40907021 DERIVED

Related Links

• Clinical trials at UNC Lineberger

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Study Officials

• Chemtai Mungo, MD, MPH

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2024
• First Posted: July 25, 2024
• Study Start: January 22, 2025
• Primary Completion: April 8, 2026
• Study Completion: April 8, 2026
• Last Updated: April 23, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)