Evidence map›Paper›PMID 26824902›Full record

Trial reportPloS one2016

A Single-Arm, Proof-Of-Concept Trial of Lopimune (Lopinavir/Ritonavir) as a Treatment for HPV-Related Pre-Invasive Cervical Disease.

Lynne Hampson, Innocent O Maranga, Millicent S Masinde, Anthony W Oliver, Gavin Batman, Xiaotong He, Minaxi Desai, Parmenas M Okemwa, Helen Stringfellow, Pierre Martin-Hirsch and 3 more

Open access · goldAbstract readClinical Trial
In one paragraph

Trial report in PloS one, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed
1.9field-weighted citation impact, top 15% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 49 citations in OpenAlex.

  1. Trial
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  11. The Future of Cervical Cancer Screening.International journal of women's health · 2024
    Review
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  18. Increased CD4BMC infectious diseases · 2022
    Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 5 institutions in 2 countries.

Lynne HampsonUniversity of Manchester Viral Oncology Laboratories, Institute of Cancer Sciences, Research Floor 5, St Mary's Hospital, Oxford Road, Manchester M13 9WL, United Kingdom.
Innocent O MarangaKenyatta National Hospital, Department of Reproductive Health, PO Box 20723-00202, Nairobi, Kenya.
Millicent S MasindeUniversity of Nairobi, College of Health Sciences, Departments of Gynaecology and Pathology, PO Box 19676-00202, Nairobi, Kenya.
Anthony W OliverUniversity of Manchester Viral Oncology Laboratories, Institute of Cancer Sciences, Research Floor 5, St Mary's Hospital, Oxford Road, Manchester M13 9WL, United Kingdom.
Gavin BatmanUniversity of Manchester Viral Oncology Laboratories, Institute of Cancer Sciences, Research Floor 5, St Mary's Hospital, Oxford Road, Manchester M13 9WL, United Kingdom.
Xiaotong HeUniversity of Manchester Viral Oncology Laboratories, Institute of Cancer Sciences, Research Floor 5, St Mary's Hospital, Oxford Road, Manchester M13 9WL, United Kingdom.
Minaxi DesaiCytology Laboratories, PO Box 208, Clinical Sciences Building 2, Central Manchester University Hospital NHS Trust, Oxford Rd, Manchester M13 9WW, United Kingdom.
Parmenas M OkemwaUniversity of Nairobi, College of Health Sciences, Departments of Gynaecology and Pathology, PO Box 19676-00202, Nairobi, Kenya.
Helen StringfellowDepartment of Pathology, Royal Preston Hospital, Sharoe Green Lane, Fulwood, Preston, PR2 9HT, United Kingdom.
Pierre Martin-HirschDepartment of Obstetrics & Gynaecology, Royal Preston Hospital, Sharoe Green Lane, Fulwood, Preston, PR2 9HT, United Kingdom.
Alex M MwanikiUniversity of Nairobi, College of Health Sciences, Departments of Gynaecology and Pathology, PO Box 19676-00202, Nairobi, Kenya.
Peter GichangiUniversity of Nairobi, College of Health Sciences, Departments of Gynaecology and Pathology, PO Box 19676-00202, Nairobi, Kenya.
Ian N HampsonUniversity of Manchester Viral Oncology Laboratories, Institute of Cancer Sciences, Research Floor 5, St Mary's Hospital, Oxford Road, Manchester M13 9WL, United Kingdom.
University of Nairobi · KESt Mary's Hospital · GBUniversity of Manchester · GBRoyal Preston Hospital · GBKenyatta National Hospital · KE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCervical cancer is the most common female malignancy in the developing nations and the third most common cancer in women globally. An effective, inexpensive and self-applied topical treatment would be an ideal solution for treatment of screen-detected, pre-invasive cervical disease in low resource settings.

methodsBetween 01/03/2013 and 01/08/2013, women attending Kenyatta National Hospital's Family Planning and Gynaecology Outpatients clinics were tested for HIV, HPV (Cervista®) and liquid based cervical cytology (LBC-ThinPrep®). HIV negative women diagnosed as high-risk HPV positive with high grade squamous intraepithelial lesions (HSIL) were examined by colposcopy and given a 2 week course of 1 capsule of Lopimune (CIPLA) twice daily, to be self-applied as a vaginal pessary. Colposcopy, HPV testing and LBC were repeated at 4 and 12 weeks post-start of treatment with a final punch biopsy at 3 months for histology. Primary outcome measures were acceptability of treatment with efficacy as a secondary consideration.

resultsA total of 23 women with HSIL were treated with Lopimune during which time no adverse reactions were reported. A maximum concentration of 10 ng/ml of lopinavir was detected in patient plasma 1 week after starting treatment. HPV was no longer detected in 12/23 (52.2%, 95%CI: 30.6-73.2%). Post-treatment cytology at 12 weeks on women with HSIL, showed 14/22 (63.6%, 95%CI: 40.6-82.8%) had no dysplasia and 4/22 (18.2%, 95%CI: 9.9-65.1%) were now low grade demonstrating a combined positive response in 81.8% of women of which 77.8% was confirmed by histology. These data are supported by colposcopic images, which show regression of cervical lesions.

conclusionsThese results demonstrate the potential of Lopimune as a self-applied therapy for HPV infection and related cervical lesions. Since there were no serious adverse events or detectable post-treatment morbidity, this study indicates that further trials are clearly justified to define optimal regimes and the overall benefit of this therapy.

trial registrationISRCTN Registry 48776874.

Indexed as

Administration, IntravaginalAdultAntiviral AgentsCervix UteriColposcopyDrug Administration ScheduleDrug CombinationsFemaleGenotypeHumansKenyaLopinavirMolecular TypingPapillomaviridaePapillomavirus InfectionsPatient Acceptance of Health CareAntiviral AgentsDrug CombinationsLopinavirlopinavir-ritonavir drug combinationRitonavir

Identifiers

PMID26824902
PMCPMC4732739
OpenAlexW2293386949

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

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.