HPV Infection and Cervical Lesions in HIV Infected Women in Thailand: A Prospective Study (PapilloV)
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| ClinicalTrials.gov Identifier: NCT01792973 |
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Recruitment Status :
Completed
First Posted : February 15, 2013
Last Update Posted : March 22, 2017
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Sponsor:
Institut de Recherche pour le Developpement
Collaborators:
National Cancer Institute, France
Fondation de France
Information provided by (Responsible Party):
Marc Lallemant, Institut de Recherche pour le Developpement
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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 |
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:
- To evaluate the prevalence, the incidence, the persistence rate and the clearance rate of HPV cervical infection, of genotypes involved and of multiple infections.
- To evaluate the prevalence, the incidence, the progression rate and the regression rate of cyto-histological abnormalities
- To assess the efficacy of different screening algorithms using pap smear alone, pap-smear associated with HPV and HPV alone
Secondary objectives:
- To determine the risk factors of high grade lesions (Cervical intraepithelial neoplasia (CIN)2 or higher) in HIV infected Thai women
- 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 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 |
Primary Outcome Measures :
- High risk HPV infection [ Time Frame: January 2015 ]
- 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 ]
Biospecimen Retention: Samples With DNA
Cervical secretions
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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
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
Show 24 study locations
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 |
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.
| 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: | March 22, 2017 |
| Last Verified: | March 2017 |
Keywords provided by Marc Lallemant, Institut de Recherche pour le Developpement:
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HIV HPV Women |
Thailand Antiretrovirals Cervical cancer |
Additional relevant MeSH terms:
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Papillomavirus Infections Uterine Cervical Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site |
Neoplasms Uterine Cervical Diseases Uterine Diseases DNA Virus Infections Virus Diseases Tumor Virus Infections |