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

Cervical Cancer Clinical Trial

— PapilloV  

Official title:

HPV Infection and Cervical Lesions in HIV Infected Women in Thailand

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01792973
• Other study ID #: PapilloV
• Status: Completed
• Start date: February 2012
• Est. completion date: December 2016

Study information

• Verified date: October 2021
• Source: Institut de Recherche pour le Developpement
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 829
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Papillomavirus Infections
• Uterine Cervical Neoplasms

Locations

Country	Name	City	State
Thailand	Bhumibol Adulyadej Hospital	Bangkok
Thailand	Bhuddasothorn Hospital	Chachoengsao
Thailand	Prapokklao Hospital	Chanthaburi	Chantaburi
Thailand	Chiang Kham Hospital	Chiang Kham	Phayao
Thailand	Chiangrai Prachanukroh Hospital	Chiang Rai	Chiangrai
Thailand	Chonburi Hospital	Chon Buri	Chonburi
Thailand	Hat Yai Hospital	Hat Yai	Songkla
Thailand	Lampang Hospital	Lampang
Thailand	Lamphun Hospital	Lamphun	Chiang Mai
Thailand	Mae Chan Hospital	Mae Chan	Chiang Rai
Thailand	Nakornping Hospital	Mae Rim	Chiang Mai
Thailand	Mae Sai Hospital	Mae Sai	Chiang Rai
Thailand	Mahasarakam Hospital	Maha Sarakham	Mahasarakam
Thailand	Nakhonpathom Hospital	Nakhon Pathom	Nakhonpathom
Thailand	Maharat Nakhon Ratchasima Hospital	Nakhon Ratchasima
Thailand	Nong Khai Hospital	Nong Khai
Thailand	Phan Hospital	Phan	Chiang Rai
Thailand	Phayao Hospital	Phayao
Thailand	Buddhachinaraj Hospital	Phitsanulok	Pitsanulok
Thailand	Ratchaburi Hospital	Ratchaburi
Thailand	Rayong Hospital	Rayong
Thailand	Samutprakarn Hospital	Samut Prakan	Samutprakarn
Thailand	Samutsakorn Hospital	Samut Sakhon	Samutsakorn
Thailand	Sanpatong Hospital	San Pa Tong	Chiang Mai

Sponsors (3)

Lead Sponsor	Collaborator
Institut de Recherche pour le Developpement	Fondation de France, National Cancer Institute, France

Country where clinical trial is conducted

Thailand, 

References & Publications (3)

Delory T, Ngo-Giang-Huong N, Rangdaeng S, Chotivanich N, Limtrakul A, Putiyanun C, Suriyachai P, Matanasarawut W, Jarupanich T, Liampongsabuddhi P, Heard I, Jourdain G, Lallemant M, Le Coeur S; PapilloV study group. Human Papillomavirus infection and cerv — View Citation

Dub T, Le Cœur S, Ngo-Giang-Huong N, Matanasarawut W, Suriyachai P, Saisawat K, Putiyanun C, Buranabanjasatean S, Leenasirimakul P, Randaeng S, Delory T. Prevalence of High-Risk Human Papillomavirus Infections before and after Cervical Lesion Treatment, among Women Living with HIV. J Clin Med. 2021 Jul 15;10(14). pii: 3133. doi: 10.3390/jcm10143133. — View Citation

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 infe

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	High risk HPV infection	HPV16, HPV18, HPV31, HPV33, HPV35, HPV39, HPV45, HPV51, HPV52, HPV56, HPV58, HPV59, HPV68	January 2015
Primary	High grade cervical lesions	Cervical intraepithelial neoplasia grade 2 or higher (CIN2+) in histology, and high grade squamous intraepithelial lesions or higher (HSIL+) in cytology	Up to 3 years