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

February 11, 2013
July 24, 2014
February 2012
December 2015   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01792973 on ClinicalTrials.gov Archive Site
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HPV Infection and Cervical Lesions in HIV Infected Women in Thailand: A Prospective Study
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Cervical secretions

Non-Probability Sample

HIV-infected women followed in the PHPT cohort

Cervical Cancer
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
884
June 2016
December 2015   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT01792973
PapilloV
Yes
Marc Lallemant, Institut de Recherche pour le Developpement
Institut de Recherche pour le Developpement
  • National Cancer Institute, France
  • Fondation de France
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
Institut de Recherche pour le Developpement
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP