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

NCT01792973 | Completed DMC

• 1 other identifier: PapilloV
• Study Type: observational
• Target: 829
• Locations: 1 country
• Sites: 24

Brief 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). 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.

Conditions

Cervical Cancer

Keywords

HIV; HPV; Women; Thailand; Antiretrovirals; Cervical cancer

Outcome Measures

Primary Outcomes (2)

• High risk HPV infection

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

  January 2015

• 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

  Up to 3 years

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HIV-infected women followed in the PHPT cohort

You may qualify if:

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

Sponsors & Collaborators

• Institut de Recherche pour le Developpement: lead
• National Cancer Institute, France: collaborator
• Fondation de France: collaborator

Study Sites (24)

Prapokklao Hospital

Chanthaburi, Changwat Chanthaburi, 22000, Thailand

Location

Mae Chan Hospital

Mae Chan, Changwat Chiang Rai, Thailand

Location

Mae Sai Hospital

Mae Sai, Changwat Chiang Rai, 57130, Thailand

Location

Phan Hospital

Phan, Changwat Chiang Rai, 57120, Thailand

Location

Chonburi Hospital

Chon Buri, Changwat Chon Buri, 20000, Thailand

Location

Chiang Kham Hospital

Chiang Kham, Changwat Phayao, 56110, Thailand

Location

Buddhachinaraj Hospital

Phitsanulok, Changwat Phitsanulok, Thailand

Location

Hat Yai Hospital

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

Lamphun Hospital

Lamphun, Chiang Mai, 51000, Thailand

Location

Nakornping Hospital

Mae Rim, Chiang Mai, 50180, Thailand

Location

Sanpatong Hospital

San Pa Tong, Chiang Mai, 20120, Thailand

Location

Chiangrai Prachanukroh Hospital

Chiang Rai, Chiangrai, Thailand

Location

Mahasarakam Hospital

Maha Sarakham, Mahasarakam, 44000, Thailand

Location

Nakhonpathom Hospital

Nakhon Pathom, Nakhonpathom, 73000, Thailand

Location

Samutprakarn Hospital

Mueang Samut Prakan, Samutprakarn, Thailand

Location

Samutsakorn Hospital

Samut Sakhon, Samutsakorn, Thailand

Location

Bhumibol Adulyadej Hospital

Bangkok, Thailand

Location

Bhuddasothorn Hospital

Chachoengsao, Thailand

Location

Lampang Hospital

Lampang, 52000, Thailand

Location

Maharat Nakhon Ratchasima Hospital

Nakhon Ratchasima, Thailand

Location

Nong Khai Hospital

Nong Khai, Thailand

Location

Phayao Hospital

Phayao, 56000, Thailand

Location

Ratchaburi Hospital

Ratchaburi, Thailand

Location

Rayong Hospital

Rayong, 21000, Thailand

Location

Related Publications (3)

• 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.

  PMID: 34300302 BACKGROUND

• 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.

  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.

  PMID: 28254419 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Cervical secretions

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Sophie Le Coeur, MD, PhD

  Institut National d'Etudes Démographiques

  PRINCIPAL INVESTIGATOR

• Gonzague Jourdain, MD, PhD

  Institut de Recherche pour le Developpement

  PRINCIPAL INVESTIGATOR

• Nicole Ngo-Giang- Huong, PharmaD, PhD

  Institut de Recherche pour le Developpement

  PRINCIPAL INVESTIGATOR

• Isabelle Heard, MD, PhD

  Centre national de réference des papillomavirus humains, Institut Pasteur

  PRINCIPAL INVESTIGATOR

• Aram Limtrakul, MD

  Nakornping Hospital, Minsitry of Public Health

  PRINCIPAL INVESTIGATOR

• Nantasak Chotivanich, MD

  Chonburi Hospital, Minsitry of Public Health

  PRINCIPAL INVESTIGATOR

• Chaiwat Putiyanun, MD

  Chiang Kham Hospital, Ministry of Public Health

  PRINCIPAL INVESTIGATOR

• Samreung Rangdaeng, Associate professor

  Department of Pathology Faculty of Medicine, Chiang Mai University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Institut de Recherche pour le Developpement

Study Record Dates

• First Submitted: February 11, 2013
• First Posted: February 15, 2013
• Study Start: February 1, 2012
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 22, 2021

Record last verified: 2021-10

Locations

TH (24)