AzTrials
AzTrials

Cervical CancerPapilloVNCT01792973

HPV Infection and Cervical Lesions in HIV Infected Women in Thailand: A Prospective Study

An observational study of Cervical Cancer, run by Institut de Recherche pour le Developpement at 24 sites in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

HIV-infected women are at high risk of developing cervical cancer. This is a 3-year cohort study nested in the already existing Program for HIV Prevention and Treatment (PHPT) cohort of HIV-infected patients in Thailand (NCT 00433030). Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Cervical Cancer
How many people
829 participants
Where
24 sitesThailand
Study dates
Feb 2012to Dec 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: HIV-infected women followed in the PHPT cohort

Who may be able to join

  • HIV infected women, older than 18 years of age, followed in the PHPT cohort

Who cannot join

  • Virginity, total hysterectomy, pregnancy after 3rd month, inclusion in a HPV vaccination trial

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

Thailand24 sites

  • Bhumibol Adulyadej Hospital

    Bangkok

  • Bhuddasothorn Hospital

    Chachoengsao

  • Prapokklao Hospital

    Chanthaburi, Changwat Chanthaburi, 22000

  • Chiang Kham Hospital

    Chiang Kham, Changwat Phayao, 56110

  • Chiangrai Prachanukroh Hospital

    Chiang Rai, Chiangrai

  • Chonburi Hospital

    Chon Buri, Changwat Chon Buri, 20000

  • Hat Yai Hospital

    Hat Yai, Changwat Songkhla, 90110

  • Lampang Hospital

    Lampang, 52000

  • Lamphun Hospital

    Lamphun, Chiang Mai, 51000

  • Mae Chan Hospital

    Mae Chan, Changwat Chiang Rai

  • Nakornping Hospital

    Mae Rim, Chiang Mai, 50180

  • Mae Sai Hospital

    Mae Sai, Changwat Chiang Rai, 57130

  • Mahasarakam Hospital

    Maha Sarakham, Mahasarakam, 44000

  • Samutprakarn Hospital

    Mueang Samut Prakan, Samutprakarn

  • Nakhonpathom Hospital

    Nakhon Pathom, Nakhonpathom, 73000

  • Maharat Nakhon Ratchasima Hospital

    Nakhon Ratchasima

  • Nong Khai Hospital

    Nong Khai

  • Phan Hospital

    Phan, Changwat Chiang Rai, 57120

  • Phayao Hospital

    Phayao, 56000

  • Buddhachinaraj Hospital

    Phitsanulok, Changwat Phitsanulok

  • Ratchaburi Hospital

    Ratchaburi

  • Rayong Hospital

    Rayong, 21000

  • Samutsakorn Hospital

    Samut Sakhon, Samutsakorn

  • Sanpatong Hospital

    San Pa Tong, Chiang Mai, 20120

Other trials in Thailand

About this study

Official title: HPV Infection and Cervical Lesions in HIV Infected Women in Thailand

HIV-infected women are at high risk of developing cervical cancer. This is a 3-year cohort study nested in the already existing Program for HIV Prevention and Treatment (PHPT) cohort of HIV-infected patients in Thailand (NCT 00433030). The main objective is to assess the prevalence, incidence, and clearance rate of HPV cervical infection and associated cervical lesion. The study will also provide the distribution of the HPV genotypes involved as well as other risk factors of cervical lesions. HIV-infected women receiving antiretrovirals, older than18 years of age, followed in the PHPT cohort or in the same hospitals are proposed to participate. An annual gynecological examination with a Pap-smear and a sampling for HPV testing is performed. Women with abnormal Pap-smear or with High-Risk HPV (HR-HPV) infection receive a more intensive follow-up with a colposcopy and a biopsy if necessary. Treatment is provided according to the National Guidelines.

Read the detailed description

Title of the study: HPV Infection and Cervical Lesions in HIV infected Thai Women - A Prospective Study Country: Thailand Study period: 3 years Planned enrollment duration: 6 months

Primary objectives:

  1. To evaluate the prevalence, the incidence, the persistence rate and the clearance rate of HPV cervical infection, of genotypes involved and of multiple infections.
  2. To evaluate the prevalence, the incidence, the progression rate and the regression rate of cyto-histological abnormalities
  3. To assess the efficacy of different screening algorithms using pap smear alone, pap-smear associated with HPV and HPV alone

Secondary objectives:

  1. To determine the risk factors of high grade lesions (Cervical intraepithelial neoplasia (CIN)2 or higher) in HIV infected Thai women
  2. To evaluate cyto-histology performances at different hospital levels Methods: A multicenter prospective cohort study nested in the PHPT cohort.

Inclusion criteria: HIV infected women, older than18 years of age, followed in the PHPT cohort or in the same hospitals.

Exclusion criteria: Virginity, total hysterectomy, pregnancy after 3rd month, inclusion in a HPV vaccination trial Planned number of patients to be enrolled: 884

Follow-up procedures:

Annual gynecological examination with a Pap-smear and a sampling for HPV testing is planned.

Women with abnormal Pap-smear or with High-Risk HPV (HR-HPV) infection will be referred to a colposcopist.

In case of abnormalities at the colposcopy, a biopsy will be performed.

  • If the biopsy is normal or shows a CIN1, the women will be referred for a new colposcopic examination 6 months later.
  • If the biopsy shows CIN2 or more, treatment will be provided -LEEP or conisation, or hysterectomy, and the women will be referred for a new colposcopic examination 6 months later.

Biological and pathological procedures:

  • Pap-smears will be read by local pathologists in participating hospital.
  • Biopsies will be read by local pathologists in participating hospital.
  • HPV tests will all be performed in the PHPT virological laboratory in Chiang Mai.

Statistical methodology:

Descriptive statistics, univariate and multivariate analyses.

Conditions
Cervical Cancer
Keywords
HIV, HPV, Women, Thailand, Antiretrovirals, Cervical cancer
Medical subject headings
Uterine Cervical Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. High risk HPV infection

    HPV16, HPV18, HPV31, HPV33, HPV35, HPV39, HPV45, HPV51, HPV52, HPV56, HPV58, HPV59, HPV68

    Measured: January 2015

  2. High grade cervical lesions

    Cervical intraepithelial neoplasia grade 2 or higher (CIN2+) in histology, and high grade squamous intraepithelial lesions or higher (HSIL+) in cytology

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2013 (estimated)
  2. Study startFeb 2012
  3. Primary completionDec 2016
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
829 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01792973
Sponsor's protocol ID
PapilloV
Acronym
PapilloV
Status last verified
Oct 2021
First submitted
11 Feb 2013
Last updated
22 Oct 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • Dub T, Le Coeur S, Ngo-Giang-Huong N, Matanasarawut W, Suriyachai P, Saisawat K, Putiyanun C, Buranabanjasatean S, Leenasirimakul P, Randaeng S, Delory T. Prevalence of High-Risk Human Papillomavirus Infections before and after Cervical Lesion Treatment, among Women Living with HIV. J Clin Med. 2021 Jul 15;10(14):3133. doi: 10.3390/jcm10143133.

    PubMed 34300302

  • Le Coeur Sophie, Delory Tristan, Ngo-Giang-Huong Nicole, Rangdaeng Samreung, Heard Isabelle, Limtrakul Aram, Chotivanich Nantasak, Putiyanun Chaiwat, Leenasirimakul Prattana, Jourdain Gonzague. 2015. -"HPV Genotypes and factors associated with HR-HPV infection in HIV-infected women on Antiretroviral Therapy (ART) in Thailand: a national cohort". 30th International Papillomavirus Conference (HPV 2015), Lisbon, Portugal. 9-11 sept. 2015.

  • Delory T, Ngo-Giang-Huong N, Rangdaeng S, Chotivanich N, Limtrakul A, Putiyanun C, Suriyachai P, Matanasarawut W, Jarupanich T, Liampongsabuddhi P, Heard I, Jourdain G, Lallemant M, Le Coeur S; PapilloV study group. Human Papillomavirus infection and cervical lesions in HIV infected women on antiretroviral treatment in Thailand. J Infect. 2017 May;74(5):501-511. doi: 10.1016/j.jinf.2017.02.007. Epub 2017 Feb 28.

    PubMed 28254419

Questions about this trial

What is this clinical trial studying?

An observational study of Cervical Cancer, run by Institut de Recherche pour le Developpement at 24 sites in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

High risk HPV infection (time frame: January 2015). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01792973, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2021.

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