Clinical trial · Interventional
Acceptability and Feasibility of Combination Treatment for Cervical Precancer Among South African Women Living With HIV
NCT05413811CI-TRIAL-00123220ACT 2completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
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.
Conditions
Conditions (5)
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 Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| CIN2 | — | UNRESOLVED | — |
| CIN3 | — | UNRESOLVED | — |
| Human Immunodeficiency Virus | — | UNRESOLVED | — |
| Human Papillomavirus | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5 Fluorouracil (5 FU) Cream | Drug | Fluorouracil | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 5 Fluorouracil (5FU) Cream
- description
- Participants self-administered 2 grams intravaginal 5FU cream at study weeks 4, 6, 8, 10, 12, 14, 16, and 18 (8 doses over 16 weeks total).
- interventionNames
- Drug: 5 Fluorouracil (5 FU) Cream
- type
- PLACEBO_COMPARATOR
- label
- Placebo Cream
- description
- Participants self-administered intravaginal placebo cream (an inert emollient that mimics the 5FU cream) at study weeks 4, 6, 8, 10, 12, 14, 16, and 18 (8 doses over 16 weeks total).
- interventionNames
- Drug: Placebo
Primary outcomes (6)
- measure
- Number of Participants Retained in the Study Through Week 24
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed HIV-1 infection * On antiretroviral therapy (ART), for at least 90 days prior to enrollment * Cervical biopsy demonstrating CIN2/3 within the preceding 120 days. Exclusion Criteria: * pregnancy, * breastfeeding, * intend to become pregnant within 180 days of enrollment * have an active sexually transmitted infection (women may participate once treated) * have a surgically absent cervix * have a history of anogenital (cervical, vaginal, vulvar, or anal) cancer or a biopsy suspicious for cervical cancer * have a medical comorbidity that would interfere with study participation.
References
Publications (4)
- DERIVEDTeodoro NS, Mollan KR, Keys JR, Liu C, Mulongo M, Gumede S, Pasipamire T, Faesen M, Mischell MA, Rahangdale L, Chibwesha CJ. Acceptability and Feasibility of Combination Treatment for Cervical Precancer Among Women Living with HIV in South Africa: Primary Outcomes from the ACT 2 Randomized Trial. medRxiv [Preprint]. 2026 Mar 16:2026.03.14.26348308. doi: 10.64898/2026.03.14.26348308. PMID 41891028
- DERIVEDChibwesha CJ, Teodoro NS, Mollan KR, Keys JR, Liu C, Mulongo M, Gumede S, Pasipamire T, Faesen M, Rahangdale L. Efficacy of Combination Treatment for Cervical Precancer Among Women Living with HIV in South Africa: Secondary Outcomes from the ACT 2 Randomized Controlled Trial. medRxiv [Preprint]. 2026 Mar 22:2026.03.19.26348810. doi: 10.64898/2026.03.19.26348810. PMID 41890998
- DERIVEDChibwesha CJ, Mollan KR, Teodoro NS, Keys JR, Liu C, Mulongo M, Gumede S, Pasipamire T, Faesen M, Rahangdale L. Randomized clinical trial protocol: Acceptability and feasibility of combination treatment for cervical precancer among South African women living with HIV (ACT 2). Contemp Clin Trials. 2026 May;164:108272. doi: 10.1016/j.cct.2026.108272. Epub 2026 Mar 2. PMID 41780745
- DERIVEDChibwesha CJ, Mollan KR, Teodoro NS, Keys JR, Liu C, Mulongo M, Gumede S, Pasipamire T, Faesen M, Rahangdale L. ACT 2 Clinical Trial Design: Acceptability and Feasibility of Combination Treatment for Cervical Precancer Among South African Women Living with HIV. medRxiv [Preprint]. 2025 Aug 14:2025.08.12.25333540. doi: 10.1101/2025.08.12.25333540. PMID 40832398