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

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ClinicalTrials.gov Identifier: NCT01792973
Recruitment Status : Completed
First Posted : February 15, 2013
Last Update Posted : October 22, 2021
Sponsor:
Collaborators:
National Cancer Institute, France
Fondation de France
Information provided by (Responsible Party):
Marc Lallemant, Institut de Recherche pour le Developpement

Study Description
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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.

Condition or disease
Cervical Cancer

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.

Study Design
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Study Type : Observational
Actual Enrollment : 829 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: HPV Infection and Cervical Lesions in HIV Infected Women in Thailand
Actual Study Start Date : February 2012
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. High risk HPV infection [ Time Frame: January 2015 ]
    HPV16, HPV18, HPV31, HPV33, HPV35, HPV39, HPV45, HPV51, HPV52, HPV56, HPV58, HPV59, HPV68

  2. High grade cervical lesions [ Time Frame: Up to 3 years ]
    Cervical intraepithelial neoplasia grade 2 or higher (CIN2+) in histology, and high grade squamous intraepithelial lesions or higher (HSIL+) in cytology


Biospecimen Retention:   Samples With DNA
Cervical secretions

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01792973


Locations
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Sponsors and Collaborators
Institut de Recherche pour le Developpement
National Cancer Institute, France
Fondation de France
Investigators
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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
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Publications of Results:
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.

Other Publications:

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Responsible Party: Marc Lallemant, Institut de Recherche pour le Developpement
ClinicalTrials.gov Identifier: NCT01792973    
Other Study ID Numbers: PapilloV
First Posted: February 15, 2013    Key Record Dates
Last Update Posted: October 22, 2021
Last Verified: October 2021
Keywords provided by Marc Lallemant, Institut de Recherche pour le Developpement:
HIV
HPV
Women
 Thailand
Antiretrovirals
Cervical cancer
Additional relevant MeSH terms:
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Papillomavirus Infections
Uterine Cervical Neoplasms
Infections
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Uterine Cervical Diseases
Uterine Diseases
DNA Virus Infections
Virus Diseases
Tumor Virus Infections