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

NCT01792973 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 829

Last updated 2021-10-22

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • National Cancer Institute, France

    collaborator OTHER_GOV

  • Fondation de France

    collaborator OTHER

  • Institut de Recherche pour le Developpement

    lead OTHER_GOV

Principal Investigators

  • Sophie Le Coeur, MD, PhD · Institut National d'Etudes Démographiques

  • Gonzague Jourdain, MD, PhD · Institut de Recherche pour le Developpement

  • Nicole Ngo-Giang- Huong, PharmaD, PhD · Institut de Recherche pour le Developpement

  • Isabelle Heard, MD, PhD · Centre national de réference des papillomavirus humains, Institut Pasteur

  • Aram Limtrakul, MD · Nakornping Hospital, Minsitry of Public Health

  • Nantasak Chotivanich, MD · Chonburi Hospital, Minsitry of Public Health

  • Chaiwat Putiyanun, MD · Chiang Kham Hospital, Ministry of Public Health

  • Samreung Rangdaeng, Associate professor · Department of Pathology Faculty of Medicine, Chiang Mai University

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Thailand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01792973 on ClinicalTrials.gov