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NCT05362955
5-fluorouracil Following Cervical Intraepithelial Neoplasia Treatment Among HIV-positive Women in East Africa
Phase 1 trial testing Intravaginal 5-Fluorouracil (5-FU) in CIN 2/3 in 12 participants. Completed in 1 February 2024.
1 February 2024
Quick facts
| Lead sponsor | UNC Lineberger Comprehensive Cancer Center |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 12 |
| Start date | 26 April 2023 |
| Primary completion | 1 February 2024 |
| Estimated completion | 1 February 2024 |
| Sites | 1 location across Kenya |
Drugs / interventions tested
- Intravaginal 5-Fluorouracil (5-FU) — full drug profile →
Conditions studied
- CIN 2/3 — all drugs for CIN 2/3 →
- HIV Infections — all drugs for HIV Infections →
Sponsor
UNC Lineberger Comprehensive Cancer Center — full company profile →
Who can join
Adults 18 to 49, female only, with CIN 2/3 or HIV Infections. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Viral oncogenesis in cancer: from mechanisms to therapeutics.
Xiao Q, Liu Y, Li T, Wang C, et al · · 2025 · cited 45× · PMID 40350456 · DOI 10.1038/s41392-025-02197-9 -
Feasibility of 5-fluorouracil and imiquimod for the topical treatment of cervical intraepithelial neoplasias (CIN) 2/3.
Desravines N, Hsu CH, Mohnot S, Sahasrabuddhe V, et al · · 2023 · cited 21× · PMID 37431689 · DOI 10.1002/ijgo.14983 -
Men's perceptions and perceived acceptability of their female partner's use of self-administered intravaginal therapies for treatment of cervical precancer in Kenya.
Mungo C, Adewumi K, Ellis G, Rop M, et al · · 2024 · cited 7× · PMID 39021542 · DOI 10.3332/ecancer.2024.1719 -
Women's experiences and acceptability of self-administered, home delivered, intravaginal 5-Fluorouracil cream for cervical precancer treatment in Kenya.
Adewumi K, Kachoria AG, Adoyo E, Rop M, et al · · 2025 · cited 4× · PMID 39980670 · DOI 10.3389/frph.2025.1487264 -
Safety and adherence to self-administered intravaginal 5-fluorouracil cream following cervical intraepithelial neoplasia (CIN) 2/3 treatment among HIV-positive women in Kenya: A phase 1 clinical trial.
Mungo C, Omoto J, Ogollah C, Owaya A, et al · · 2025 · cited 4× · PMID 39723608 · DOI 10.1002/ijgo.16093 -
'ARVs is for HIV and cream is for HPV or precancer:' Women's perceptions and perceived acceptability of self-administered topical therapies for cervical precancer treatment: a qualitative study from Kenya.
Mungo C, Kachoria AG, Adoyo E, Zulu G, et al · · 2025 · cited 3× · PMID 40556801 · DOI 10.3332/ecancer.2025.1903 -
Women’s experiences and acceptability of self-administered, home delivered, intravaginal 5-Fluorouracil cream for cervical precancer treatment in Kenya
Adewumi K, Kachoria AG, Adoyo E, Rop M, et al · · 2024 · DOI 10.1101/2024.08.27.24312651 -
Safety and adherence to self-administered intravaginal 5-fluorouracil cream following cervical intraepithelial neoplasia (CIN) 2/3 treatment among HIV-positive women in Kenya: A phase 1 clinical trial
Mungo C, Omoto J, Ogollah C, Owaya A, et al · · 2024 · DOI 10.1101/2024.06.06.24308548
Verify or expand the search:
- PubMed search for NCT05362955
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for CIN 2/3
Currently open trials in the same condition.
- NCT04910802 — Concomitant HPV Vaccination and HPV Screening HPV Infection and Cervical Cancer in Sweden · Phase 4 · recruiting
- NCT04098744 — Artesunate Vaginal Inserts for the Treatment of Cervical Intraepithelial Neoplasia (CIN2/3) · Phase 2 · recruiting
Other UNC Lineberger Comprehensive Cancer Center trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05362955 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center
- Last refreshed: 23 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05362955.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing