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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Institut de Recherche pour le Developpement
Sponsor:
Collaborators:
National Cancer Institute, France
Fondation de France
Information provided by (Responsible Party):
Marc Lallemant, Institut de Recherche pour le Developpement
ClinicalTrials.gov Identifier:
NCT01792973
First received: February 11, 2013
Last updated: February 13, 2013
Last verified: February 2013
  Purpose

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.


Condition
Cervical Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: HPV Infection and Cervical Lesions in HIV Infected Women in Thailand

Resource links provided by NLM:


Further study details as provided by Institut de Recherche pour le Developpement:

Primary Outcome Measures:
  • High risk HPV infection [ Time Frame: January 2015 ] [ Designated as safety issue: No ]
  • Cervical lesions: cytological abnormalities of squamous cells: ASC-US, ASC-H, LSIL, HSIL or SCC (ASCUS +) or glandular cells (AGC, AGC favor neoplasia or adenocarcinoma) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Cervical secretions


Estimated Enrollment: 884
Study Start Date: February 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

HIV-infected women followed in the PHPT cohort

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01792973

Contacts
Contact: Sophie Le Coeur, MD, PhD +66 (0) 53 819 125 ext 200 Sophie.LeCoeur@phpt.org

Locations
Thailand
Bhumibol Adulyadej Hospital Recruiting
Saimai, Bangkok, Thailand
Principal Investigator: Sinart Prommas, MD         
Prapokklao Hospital Recruiting
Prapokklao, Muang, Chantaburi, Thailand, 22000
Contact: Prapap Yuthavisuthi, MD       yuthavisuthi@gmail.com   
Principal Investigator: Prapap Yuthavisuthi, MD         
Nakornping Hospital Recruiting
Mae Rim, Chiang Mai, Thailand, 50180
Contact: Prattana Leenasirimakul, MD       prattanalee@hotmail.com   
Principal Investigator: Aram Limtrakul, MD         
Lamphun Hospital Recruiting
Muang, Chiang Mai, Thailand, 51000
Contact: Nuananong Luekamlung, MD       nleerayu@yahoo.co.th   
Principal Investigator: Nuananong Luekamlung, MD         
Sanpatong Hospital Recruiting
Sanpatong, Chiang Mai, Thailand, 20120
Contact: Virat Klinbuayaem, MD    053 825265    kggvirat@hotmail.com   
Principal Investigator: Virat Klinbuayaem, MD         
Mae Chan Hospital Recruiting
Mae Chan, Chiang Rai, Thailand
Contact: Sudanee Buranabanjasatean, MD       sudanee2011@windowslive.com   
Principal Investigator: Sudanee Buranabanjasatean, MD         
Mae Sai Hospital Recruiting
Mae Sai, Chiang Rai, Thailand, 57130
Contact: Rattakarn Paramee, MD       prattakarn@yahoo.com   
Principal Investigator: Rattakarn Paramee, MD         
Phan Hospital Recruiting
Phan, Chiang Rai, Thailand, 57120
Contact: Sookchai Theansavettrakul, MD       scthean@gmail.com   
Principal Investigator: Sookchai Theansavettrakul, MD         
Chiangrai Prachanukroh Hospital Recruiting
Muang, Chiangrai, Thailand
Contact: Pacharee Kantipong       pachareek@hotmail.com   
Principal Investigator: Pacharee Kantipong, MD         
Chonburi Hospital Recruiting
Muang, Chonburi, Thailand, 20000
Contact: Chureeratana Bowonwatanuwong, MD       Cbowon@chonburi.ksc.co.th   
Principal Investigator: Nantasak Chotivanich, MD         
Lampang Hospital Recruiting
Muang, Lampang, Thailand, 52000
Contact: Panita Pathipvanich, MD       panitapa@yahoo.com   
Principal Investigator: Panita Pathipvanich, MD         
Mahasarakam Hospital Recruiting
Muang, Mahasarakam, Thailand, 44000
Contact: Suchart Thongpaen, MD       SCTP_16@hotmail.com   
Principal Investigator: Suchart Thongpaen, MD         
Nakhonpathom Hospital Recruiting
Muang, Nakhonpathom, Thailand, 73000
Contact: Rucha Kongpanichkul, MD       ruchakong@gmail.com   
Principal Investigator: Rucha Kongpanichkul, MD         
Nong Khai Hospital Recruiting
Muang, Nong Khai, Thailand
Contact: Naruepon Yutthakasemsunt, MD         
Principal Investigator: Naruepon Yutthakasemsunt, MD         
Chiang Kham Hospital Recruiting
Chiang Kham, Phayao, Thailand, 56110
Contact: Chaiwat Putiyanun, MD       putiyanun@hotmail.com   
Principal Investigator: Chaiwat Putiyanun, MD         
Buddhachinaraj Hospital Recruiting
Muang, Pitsanulok, Thailand
Contact: Somboon Tansuphasawasdikul       Somboontansuphaswasdikul@yahoo.com   
Principal Investigator: Somboon Tansuphasawasdikul, MD         
Ratchaburi Hospital Recruiting
Muang, Ratchaburi, Thailand
Contact: Pensiriwan Sang-a-gad, MD       pensiriwan@yahoo.com   
Principal Investigator: Pensiriwan Sang-a-gad, MD         
Rayong Hospital Recruiting
Muang, Rayong, Thailand, 21000
Contact: Sukit Banchongkit, MD       sbanchongkit@yahoo.com   
Principal Investigator: Sukit Banchongkit, MD         
Samutprakarn Hospital Recruiting
Pak Nam, Samutprakarn, Thailand
Contact: Naree Eiamsirikit, MD       phatarapun@yahoo.co.th   
Principal Investigator: Naree Eiamsirikit, MD         
Samutsakorn Hospital Recruiting
Muang, Samutsakorn, Thailand
Contact: Apichat Chutanunta, MD       dr.apichati@gmail.com   
Principal Investigator: Apichat Chutanunta, MD         
Hat Yai Hospital Recruiting
Hat Yai, Songkla, Thailand, 90110
Contact: Tapnarong Jarupanich, MD       tapnarong@hotmail.com   
Principal Investigator: Tapnarong Jarupanich, MD         
Bhuddasothorn Hospital Recruiting
Chachoengsao, Thailand
Contact: Pakorn Wittayapraparat       pakornwit@hotmail.com   
Principal Investigator: Pakorn Wittayapraparat, MD         
Maharat Nakhon Ratchasima Hospital Recruiting
Nakhonratchasima, Thailand
Contact: Rittha Lertkoonalak, MD       KANYAREHAB@hotmail.com   
Principal Investigator: Rittha Lertkoonalak, MD         
Phayao Hospital Recruiting
Phayao, Thailand, 56000
Contact: Guttiga Halue, MD       drgutti@gmail.com   
Principal Investigator: Guttiga Halue, MD         
Sponsors and Collaborators
Institut de Recherche pour le Developpement
National Cancer Institute, France
Fondation de France
Investigators
Principal Investigator: 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
  More Information

No publications provided

Responsible Party: Marc Lallemant, Institut de Recherche pour le Developpement
ClinicalTrials.gov Identifier: NCT01792973     History of Changes
Other Study ID Numbers: PapilloV
Study First Received: February 11, 2013
Last Updated: February 13, 2013
Health Authority: Thailand: Ministry of Public Health

Keywords provided by Institut de Recherche pour le Developpement:
HIV
HPV
Women
Thailand
Antiretrovirals
Cervical cancer

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 22, 2014