Clinical trial · Interventional
Adjuvant 5-Fluorouracil Following Thermal Ablation to Improve HPV Treatment Outcomes in Women With HIV in Kenya
Adjuvant 5-Fluorouracil Following Thermal Ablation to Improve HPV Treatment Outcomes in Women With HIV in Kenya : The ASCEND Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This randomized, placebo-controlled trial will evaluate self-administered 5-fluorouracil (5FU) to improve human papillomavirus (HPV) clearance after thermal ablation (TA) in Women With Human Immunodeficiency Virus (HIV) (WWH) in Kenya. The trial will also assess the safety, adherence, and acceptability of 5FU. Starting four weeks after TA, participants will self-administer 5FU cream or matched placebo intravaginally once every other week for 12 applications, with clinic visits at weeks 2, 8, 16, 24, and 48 for evaluation. All participants will be followed up to 48 weeks. It is hypothesized that, compared to placebo, 5FU will increase HPV clearance at 24 weeks and that the proposed dosing schedule will be safe, well-tolerated, and acceptable in this population. Together with data from other studies, this trial will provide evidence on the use of self-administered intravaginal 5FU to improve HPV treatment outcomes in WWH in low- and middle-income countries, where the burden of cervical cancer is highest.
Conditions
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Intraepithelial Neoplasia Grade 1 | — | UNRESOLVED | — |
| Cervical Intraepithelial Neoplasia Grade 2/3 | Cervical Intraepithelial Neoplasia Grade 2/3 | ONTOLOGY_EXACT | 0.98 |
| Cervical Intraepithelial Neoplasia Grade 3 | — | UNRESOLVED | — |
| Cervix Cancer | — | UNRESOLVED | — |
| CIN | Cervical Intraepithelial Neoplasia | CURATED_BROADER | 0.80 |
| CIN1 | — | UNRESOLVED | — |
| CIN2 | — | UNRESOLVED | — |
| CIN3 | — | UNRESOLVED | — |
| HIV Infections |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5% 5-fluorouracil Topical Cream | Drug | Fluorouracil | ALIAS |
| Placebo Cream | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 5% 5-fluorouracil
- description
- Participants will receive 12 doses of intravaginal 5FU cream.
- interventionNames
- Drug: 5% 5-fluorouracil Topical Cream
- type
- PLACEBO_COMPARATOR
- label
- Placebo cream
- description
- Participants will receive 12 doses of intravaginal placebo cream.
- interventionNames
- Drug: Placebo Cream
Primary outcomes (1)
- measure
- High-risk human papillomavirus (hrHPV) Clearance among WWH randomized to adjuvant self-administered 5FU cream versus placebo cream following Thermal ablation (TA)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
Show eligibility criteria text
Inclusion Criteria * Women aged 25 years or older * Known HIV-positive status * On antiretroviral therapy (ART) for at least 60 days prior to enrollment * Positive HPV screening test screening result * Able to provide informed consent in English, Swahili, or Dholuo * Agree to use dual contraception during dosing phase if of childbearing potential * Planning to remain in study locale for duration of study (48 weeks) Exclusion Criteria * Current pregnancy or breastfeeding * History of anogenital cancer (cervical, vulvar, or anal) * Current use of immunosuppressive medications * History of total hysterectomy * Known allergy to 5FU * Medical comorbidity that would interfere with study participation * Unwilling or unable to use contraception during study participation
References
Publications (0)
Data not yet available