CClinicalTrials.gg
CompletedNCT01226368HP2V-AGUpdated Oct 30, 2014

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

An observational study in 1- Women, 2- HIV Infection and 3- Followed in West Indies and French Guiana for His Infection, sponsored by University Hospital Center of Martinique. Completed at 1 site in Martinique. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-10-30.

Sponsored by University Hospital Center of Martinique · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
455
Ages
18 Years and older
Sex
Female
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Study summary

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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Conditions studied

  • 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

Keywords

  • HIV, HPV, cervical-vaginal smear
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In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 455 is above the median of 240 across 2,136 observational studies indexed under Infections.

Browse Infections studies →

Lead sponsor

University Hospital Center of Martinique is the lead sponsor of 77 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult HIV-Infected women followed in one of the center participating in the study and who has accepted the use of Nadis® medical files.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
455 participants (actual)
Biospecimen retention
Samples with dna

Interventions

  • OtherBiological Sample collection

    Cervix cells

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What researchers measure

Primary outcomes

  1. Presence of human papillomavirus

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

    Time frame: 1 day

Secondary outcomes

  1. Characterization of Human papillomavirus genotypes

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

    Time frame: 1 day

  2. Presence and the severity of cervical injuries.

    Time frame: 1 day

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Study locations

1 site
  • Centre Hospitalier Universitaire de Fort-de-France
    Fort-de-France, 97261, Martinique
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 30, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01226368
Lead sponsor
University Hospital Center of Martinique
Collaborators
Fondation de France, Clinique Antilles-Guyane
Responsible party
Sponsor
First posted
Oct 22, 2010
Start date
Dec 2010
Primary completion
Jan 2011
Completion
Mar 2014
Last update
Oct 30, 2014

Study contacts

Sylvie ABEL, MD
study director · University Hospital Center of Martinique

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.

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