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Completed

NCT Number: NCT01226368

Epidemiology of Papillomavirus Infection (HPV) on Infected Women by Human Immunodeficience Virus (HIV) in West Indies and French Guiana.

Cervical cancer is a public health problem. In term of frequency and mortality, it represents in Martinique the third localization the most frequently diagnosed and the fifth cause of death by cancer. Cervical cancer is recognized as viro-inducted. Human papillomavirus (HPV) is the etiologic agent, as a necessary but not sufficient cause, in the cancer genesis. It is estimated than about 70 to 80% of women have been or will be infected with an HPV in their genital life, the risks factors being those of the others sexually transmitted diseases (STD). Most of HPV infection are transient, by spontaneous clearance in a few months of the virus under episomal form.

Carcinogen risk is related to viral persistency which inducts the condition of cellular transformation.

Infection persistency and subsequent carcinogen risk depend of the genotype concerned and of the host immunitary response.

HIV infection is known to be associated with an higher prevalency of one or several infection with HPV-HR.

However, no data about HIV/HPV coinfection prevalency are available nowadays in French overseas department of South America whereas they are the most affected by HIV.

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Key information

Conditions

1- Women 2- HIV Infection 3- Followed in West Indies and French Guiana for His Infection 4- Acceptance of the Use of Nadis® Medical Files Communicable Diseases DNA Virus Infections Disease Attributes Genital Diseases Infections Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Centre Hospitalier Universitaire de Fort-de-France

Fort-de-France, 97261, Martinique

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women aged 18 years old or beyond
  • Infected with HIV1 or HIV2
  • Follow up for HIV infection in one of the center participating in the study and acceptance of the use of Nadis® medical files
  • in one of the center participating in the study and acceptance of the use of Nadis® medical files within the context of follow up that should be realized according to the recommandation of undertaking: systematic Pap smear for asymptomatic patient s (expert's report, Pr.P.Yéni) or Pap smear for classical searching of any pathology of the uterine-cervix.
  • Acceptance of involvement into the study and collection of non opposition to the realization of HPV search from the sample realized for the Pap smear.

Exclusion criteria

  • Women under age
  • History of total hysterectomy
  • Patient not followed for HIV infection in one of the center involved in the study
  • Patient that did not accept the use of Nadis® medical files
  • Impossibility to realize a Pap smear
  • Refusal of study's participation

Treatment and study plan

Biological sample collection

Other

Cervix cells

Primary outcomes

  1. Presence of human papillomavirus

    Time frame: 1 day

    Presence of human papillomavirus in women's cervical smear infected with HIV and followed in West Indies and French Guiana

Secondary outcomes

  1. Characterization of Human papillomavirus genotypes

    Time frame: 1 day

    Characterization of Human papillomavirus genotype found in women's cervical smear infected with HIV and followed in West Indies and French Guiana

  2. Presence and the severity of cervical injuries.

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

University Hospital Center of Martinique

Other

Collaborators

  • Clinique Antilles-Guyane
  • Fondation de France

Registry information

Acronym: HP2V-AG

Important dates

Study start
2010
Primary completion
2011
Study completion
2014
First posted
Oct 22, 2010
Registry last updated
Oct 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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