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NCT05413811: ACT2
Acceptability and Feasibility of Combination Treatment for Cervical Precancer Among South African Women Living With HIV
NA trial testing 5 Fluorouracil (5 FU) Cream in Cervical Cancer in 180 participants. Completed in 30 June 2025.
30 June 2025
Quick facts
| Lead sponsor | UNC Lineberger Comprehensive Cancer Center |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 180 |
| Start date | 22 March 2023 |
| Primary completion | 30 June 2025 |
| Estimated completion | 30 June 2025 |
| Sites | 1 location across South Africa |
Drugs / interventions tested
- 5 Fluorouracil (5 FU) Cream — full drug profile →
- Placebo
Conditions studied
- Cervical Cancer — all drugs for Cervical Cancer →
- CIN2 — all drugs for CIN2 →
- CIN3 — all drugs for CIN3 →
- Human Immunodeficiency Virus — all drugs for Human Immunodeficiency Virus →
Sponsor
UNC Lineberger Comprehensive Cancer Center — full company profile →
Who can join
18 and older, female only, with Cervical Cancer or CIN2. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to explore whether an anti-cancer medication (5-fluorouracil cream) placed in the vagina after a surgical excision procedure is an acceptable and useful form of treatment for cervical precancer among the woman with HIV infection.
Publications & conference data
6 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 -
'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 -
Randomized clinical trial protocol: Acceptability and feasibility of combination treatment for cervical precancer among South African women living with HIV (ACT 2).
Chibwesha CJ, Mollan KR, Teodoro NS, Keys JR, et al · · 2026 · cited 1× · PMID 41780745 · DOI 10.1016/j.cct.2026.108272 -
ACT 2 Clinical Trial Design: Acceptability and Feasibility of Combination Treatment for Cervical Precancer Among South African Women Living with HIV
Chibwesha CJ, Mollan KR, Teodoro NS, Keys JR, et al · · 2025 · DOI 10.1101/2025.08.12.25333540
Verify or expand the search:
- PubMed search for NCT05413811
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Cervical Cancer
Currently open trials in the same condition.
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- NCT07225530 — Implementation of Screen, Treat, and Triage for Women Living With HIV in La Romana (iSTAR) · NA · recruiting
- NCT07209917 — Secondary Cervical Cancer Prevention of Vulnerable Women With HPV and HIV Co-infection in India · NA · recruiting
- NCT07256236 — SKB264 Plus QL1706 in Recurrent or Metastatic Cervical Cancer · 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 NCT05413811 (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: 17 February 2026
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/NCT05413811.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing