1- WomenHP2V-AGNCT01226368
Epidemiology of Papillomavirus Infection (HPV) on Infected Women by Human Immunodeficience Virus (HIV) in West Indies and French Guiana.
An observational study of 1- Women and 2- HIV Infection, run by University Hospital Center of Martinique at 1 site in Martinique.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- 1- Women, 2- HIV Infection, 3- Followed in West Indies and French Guiana for His Infection
- What is being tested?
- Biological Sample collection
- How many people
- 455 participants
- Where
- 1 siteMartinique
- Study dates
- Dec 2010to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Martinique1 site
Centre Hospitalier Universitaire de Fort-de-France
Fort-de-France, 97261
About this study
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.
Read more
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.
- 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
- Being tested
- Biological Sample collection
- Keywords
- HIV, HPV, cervical-vaginal smear
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological Sample collectionOther
Cervix cells
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of human papillomavirus
Presence of human papillomavirus in women's cervical smear infected with HIV and followed in West Indies and French Guiana
Measured: 1 day
Secondary outcomes (2)
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
Measured: 1 day
Presence and the severity of cervical injuries.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2010 (estimated)
- Study startDec 2010
- Primary completionJan 2011
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 1- WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 455 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Center of Martinique
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation de France, Clinique Antilles-Guyane
- Responsible party
- Sponsor
- Investigators
- Sylvie ABEL, MD, Study director, University Hospital Center of Martinique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01226368
- Sponsor's protocol ID
- 10/B/09
- Acronym
- HP2V-AG
- Status last verified
- Oct 2014
- First submitted
- 21 Oct 2010
- Last updated
- 30 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Papillomavirus Infection (HPV) on Infected Women by Human Immunodeficience Virus (HIV) in West Indies and French Guiana.
- ClinicalTrials.gov ID
- NCT01226368
- Acronym / sponsor ID
- HP2V-AG / 10/B/09
- 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
- Keywords
- HIV, HPV, cervical-vaginal smear
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 455 participants (actual)
- Lead sponsor
- University Hospital Center of MartiniqueUniversity, hospital or other
- Collaborators
- Fondation de France, Clinique Antilles-Guyane
- Study start
- Dec 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 22 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological Sample collectionCervix cells | Other | – |
Primary outcome
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
2 secondary outcomes
Characterization of Human papillomavirus genotypes
Time frame: 1 day
Presence and the severity of cervical injuries.
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvie ABEL, MD study director
University Hospital Center of Martinique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 1- Women and 2- HIV Infection, run by University Hospital Center of Martinique at 1 site in Martinique.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Martinique. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of human papillomavirus (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2014.