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Sophie Le Coeur, MD, PhD

Gonzague Jourdain, MD, PhD

Nicole Ngo-Giang- Huong, PharmaD, PhD

Isabelle Heard, MD, PhD

Aram Limtrakul, MD

Nantasak Chotivanich, MD

Chaiwat Putiyanun, MD

Samreung Rangdaeng, Associate professor

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.

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

HPV16, HPV18, HPV31, HPV33, HPV35, HPV39, HPV45, HPV51, HPV52, HPV56, HPV58, HPV59, HPV68

Cervical intraepithelial neoplasia grade 2 or higher (CIN2+) in histology, and high grade squamous intraepithelial lesions or higher (HSIL+) in cytology

National Cancer Institute, France

Fondation de France

Institut de Recherche pour le Developpement

Spots Global Cancer Trial Database for antiretrovirals