Trial reportAIDS (London, England)2013
Safety and efficacy of topical cidofovir to treat high-grade perianal and vulvar intraepithelial neoplasia in HIV-positive men and women.
Trial report in AIDS (London, England), 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00550589 (Phase IIA Trial of 1% Topical Cidofovir for Treatment of High-Grade Perianal Squamous Intraepithelial Lesions in HIV-Infected Men and Women), which is not on this map. Cited by 22 papers, 4 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Phase IIA Trial of 1% Topical Cidofovir for Treatment of High-Grade Perianal Squamous Intraepithelial Lesions in HIV-Infected Men and Women
Who cites it
22 citing papers in PubMed, 4 syntheses or guidelines pooled it, 65 citations in OpenAlex.
- Outcomes reported in studies of anal high-grade squamous intraepithelial lesions treatments: systematic review.BJS open · 2026Pooled it
- German-Austrian guideline on screening for anal dysplasia and anal carcinoma in people living with HIV.Journal der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology : JDDG · 2025Guideline
- Medical and surgical interventions for the treatment of usual-type vulval intraepithelial neoplasia.The Cochrane database of systematic reviews · 2016Pooled it
- Medical interventions for high-grade vulval intraepithelial neoplasia.The Cochrane database of systematic reviews · 2015Pooled it
- Tenofovir disoproxil fumarate intravaginal ring for HIV pre-exposure prophylaxis in sexually active women: a phase 1, single-blind, randomised, controlled trial.The lancet. HIV · 2019Trial
- Anal High-Grade Squamous Intraepithelial Lesions in People Living with HIV: A Systematic Review of Treatment Outcomes.Cancers · 2026Review
- Tenofovir, Interferon Pathways, and Mucosal Immunity: Implications for People Living With HIV.American journal of reproductive immunology (New York, N.Y. : 1989) · 2026Review
- Treatment Options for Anal Neoplasia: Going from Anal Dysplasia to Anal Cancer.Clinics in colon and rectal surgery · 2026Review
- Anal Cancer and Anal Intraepithelial Neoplasia Risk among Patients Treated for HPV-Related Gynecological Diseases-A Systematic Review.Journal of clinical medicine · 2023Review
- Anal Intraepithelial Neoplasia: Precursor of Anal Squamous Cell Carcinoma.Journal of the anus, rectum and colon · 2022Review
- Refractory extensive vulvar high-grade squamous intraepithelial lesion in an immunosuppressed transplant patient treated with topical cidofovir: A case report.SAGE open medical case reports · 2020Article
- Human Papilloma Virus Infection and Anal Squamous Intraepithelial Lesions.Clinics in colon and rectal surgery · 2019Review
- Practice parameters for the diagnosis and treatment of anal intraepithelial neoplasia (AIN) on behalf of the Italian Society of Colorectal Surgery (SICCR).Techniques in coloproctology · 2019Article
- Evaluation of ODE-Bn-PMEG, an acyclic nucleoside phosphonate prodrug, as an antiviral against productive HPV infection in 3D organotypic epithelial cultures.Antiviral research · 2018Article
- Topical therapies for the treatment of anal high-grade squamous intraepithelial lesions.Seminars in colon & rectal surgery · 2017Article
- [Genital warts in HIV-infected individuals].Der Hautarzt; Zeitschrift fur Dermatologie, Venerologie, und verwandte Gebiete · 2017Review
- Recent advances in understanding and preventing human papillomavirus-related disease.F1000Research · 2017Review
- Complex management of resistant oral herpes simplex virus infection following hematopoietic stem cell transplantation: potential role of topical cidofovir.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2016Article
- [HPV-induced anal lesions].Der Hautarzt; Zeitschrift fur Dermatologie, Venerologie, und verwandte Gebiete · 2015Review
- The broad-spectrum anti-DNA virus agent cidofovir inhibits lung metastasis of virus-independent, FGF2-driven tumors.Oncotarget · 2015Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 8 institutions in 2 countries.
Funding
Abstract
objectiveTo evaluate the safety and efficacy of topical cidofovir for treatment of high-grade squamous perianal intraepithelial neoplasia (PAIN) and vulvar intraepithelial neoplasia (VIN) lesions in HIV-positive individuals.
designPhase IIa prospective multicenter trial conducted at eight clinical sites through the AIDS Malignancy Consortium.
methods: HIV-positive patients with biopsy-proven high-grade PAIN that was at least 3 cm were enrolled. PAIN biopsy specimens were assessed for human papillomavirus (HPV) using PCR and type-specific HPV probing. Participants applied 1% topical cidofovir to PAIN and VIN (if present) for six 2-week cycles. Results were designated as complete response (CR), partial response (PR) (>50% reduction in size), stable disease, or progressive disease (PD).
resultsTwenty-four men and nine women (eight with high-grade VIN as well) were enrolled. Mean age was 44 years and mean CD4 cell count was 412 cells/μl. HPV DNA (most commonly HPV16) was detected in all pretreatment study specimens. Twenty six (79%) participants completed treatment per protocol: CR, five (15%); PR, 12 (36%), stable disease, seven (21%); PD, two (6%) (one with a superficially invasive cancer and one with new area of high-grade PAIN). Treatment was well tolerated with most common adverse events being mild to moderate affecting lesional skin: pain/burning/irritation (25 patients) and ulceration (13 patients).
conclusionTopical cidofovir had 51% efficacy in the short-term treatment of high-grade PAIN and VIN with acceptable toxicity in HIV-positive individuals. Randomized control studies with more prolonged treatment courses and longer follow-up to assess the durability of the response are needed.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.