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

NCT ID: NCT01792973

Last Updated: 2021-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

829 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-29

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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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

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Cervical Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Virginity, total hysterectomy, pregnancy after 3rd month, inclusion in a HPV vaccination trial
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute, France

OTHER_GOV

Sponsor Role collaborator

Fondation de France

OTHER

Sponsor Role collaborator

Institut de Recherche pour le Developpement

OTHER_GOV

Sponsor Role lead

Responsible Party

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Marc Lallemant

Institut de Recherche pour le Developpement

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sophie Le Coeur, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Institut National d'Etudes Démographiques

Gonzague Jourdain, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Institut de Recherche pour le Developpement

Nicole Ngo-Giang- Huong, PharmaD, PhD

Role: PRINCIPAL_INVESTIGATOR

Institut de Recherche pour le Developpement

Isabelle Heard, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre national de réference des papillomavirus humains, Institut Pasteur

Aram Limtrakul, MD

Role: PRINCIPAL_INVESTIGATOR

Nakornping Hospital, Minsitry of Public Health

Nantasak Chotivanich, MD

Role: PRINCIPAL_INVESTIGATOR

Chonburi Hospital, Minsitry of Public Health

Chaiwat Putiyanun, MD

Role: PRINCIPAL_INVESTIGATOR

Chiang Kham Hospital, Ministry of Public Health

Samreung Rangdaeng, Associate professor

Role: PRINCIPAL_INVESTIGATOR

Department of Pathology Faculty of Medicine, Chiang Mai University

Locations

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Prapokklao Hospital

Chanthaburi, Changwat Chanthaburi, Thailand

Site Status

Mae Chan Hospital

Mae Chan, Changwat Chiang Rai, Thailand

Site Status

Mae Sai Hospital

Mae Sai, Changwat Chiang Rai, Thailand

Site Status

Phan Hospital

Phan, Changwat Chiang Rai, Thailand

Site Status

Chonburi Hospital

Chon Buri, Changwat Chon Buri, Thailand

Site Status

Chiang Kham Hospital

Chiang Kham, Changwat Phayao, Thailand

Site Status

Buddhachinaraj Hospital

Phitsanulok, Changwat Phitsanulok, Thailand

Site Status

Hat Yai Hospital

Hat Yai, Changwat Songkhla, Thailand

Site Status

Lamphun Hospital

Lamphun, Chiang Mai, Thailand

Site Status

Nakornping Hospital

Mae Rim, Chiang Mai, Thailand

Site Status

Sanpatong Hospital

San Pa Tong, Chiang Mai, Thailand

Site Status

Chiangrai Prachanukroh Hospital

Chiang Rai, Chiangrai, Thailand

Site Status

Mahasarakam Hospital

Maha Sarakham, Mahasarakam, Thailand

Site Status

Nakhonpathom Hospital

Nakhon Pathom, Nakhonpathom, Thailand

Site Status

Samutprakarn Hospital

Mueang Samut Prakan, Samutprakarn, Thailand

Site Status

Samutsakorn Hospital

Samut Sakhon, Samutsakorn, Thailand

Site Status

Bhumibol Adulyadej Hospital

Bangkok, , Thailand

Site Status

Bhuddasothorn Hospital

Chachoengsao, , Thailand

Site Status

Lampang Hospital

Lampang, , Thailand

Site Status

Maharat Nakhon Ratchasima Hospital

Nakhon Ratchasima, , Thailand

Site Status

Nong Khai Hospital

Nong Khai, , Thailand

Site Status

Phayao Hospital

Phayao, , Thailand

Site Status

Ratchaburi Hospital

Ratchaburi, , Thailand

Site Status

Rayong Hospital

Rayong, , Thailand

Site Status

Countries

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Thailand

References

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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.

Reference Type BACKGROUND
PMID: 34300302 (View on PubMed)

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.

Reference Type RESULT

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.

Reference Type RESULT
PMID: 28254419 (View on PubMed)

Other Identifiers

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PapilloV

Identifier Type: -

Identifier Source: org_study_id