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

This study is ongoing, but not recruiting participants.
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: July 24, 2014
Last verified: July 2014
  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: June 2016
Estimated Primary Completion Date: December 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

Locations
Thailand
Bhumibol Adulyadej Hospital
Saimai, Bangkok, Thailand
Prapokklao Hospital
Prapokklao, Muang, Chantaburi, Thailand, 22000
Nakornping Hospital
Mae Rim, Chiang Mai, Thailand, 50180
Lamphun Hospital
Muang, Chiang Mai, Thailand, 51000
Sanpatong Hospital
Sanpatong, Chiang Mai, Thailand, 20120
Mae Chan Hospital
Mae Chan, Chiang Rai, Thailand
Mae Sai Hospital
Mae Sai, Chiang Rai, Thailand, 57130
Phan Hospital
Phan, Chiang Rai, Thailand, 57120
Chiangrai Prachanukroh Hospital
Muang, Chiangrai, Thailand
Chonburi Hospital
Muang, Chonburi, Thailand, 20000
Lampang Hospital
Muang, Lampang, Thailand, 52000
Mahasarakam Hospital
Muang, Mahasarakam, Thailand, 44000
Nakhonpathom Hospital
Muang, Nakhonpathom, Thailand, 73000
Nong Khai Hospital
Muang, Nong Khai, Thailand
Chiang Kham Hospital
Chiang Kham, Phayao, Thailand, 56110
Buddhachinaraj Hospital
Muang, Pitsanulok, Thailand
Ratchaburi Hospital
Muang, Ratchaburi, Thailand
Rayong Hospital
Muang, Rayong, Thailand, 21000
Samutprakarn Hospital
Pak Nam, Samutprakarn, Thailand
Samutsakorn Hospital
Muang, Samutsakorn, Thailand
Hat Yai Hospital
Hat Yai, Songkla, Thailand, 90110
Bhuddasothorn Hospital
Chachoengsao, Thailand
Maharat Nakhon Ratchasima Hospital
Nakhonratchasima, Thailand
Phayao Hospital
Phayao, Thailand, 56000
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: July 24, 2014
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 August 25, 2014