HIV Infection of the Uterine Vaginal TissuesNCT02481622
First Event of Infection by HIV-1 of Uterine Vaginal Tissue
An observational study of HIV Infection of the Uterine Vaginal Tissues, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
This non-interventional study aims to characterize the cells infected with HIV over time in different types of vagino-uterine tissue. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- HIV Infection of the Uterine Vaginal Tissues
- How many people
- 600 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2015to Nov 2019
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Women whose age ≤50 years and ≥18 years, for which surgery type laparoscopy or hysterectomy is necessary as part of a benign pathology.
Who may be able to join
- Patients whose age ≤50 years and ≥18 years
- Patients for which surgery like laparoscopy or hysterectomy is necessary as part of a benign pathology.
Who cannot join
- Patients under 18 years
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
INSERM U1109 - Institut de Virologie 3, rue Koeberlé - 67000 Strasbourg
Strasbourg, 67091
Christiane Moog, PhD, 03 68 85 37 42, c.moog@unistra.fr
Jeanine Ohl, MD, 03 88 11 67 68, jeanine.ohl@chru-strasbourg.fr
About this study
Official title: Inhibition by the Antibody, First Event of Infection by HIV-1 of Uterine Vaginal Tissue
This non-interventional study aims to characterize the cells infected with HIV over time in different types of vagino-uterine tissue.
- Keywords
- HIV infection, vaginal tissues, uterine tissues
- Medical subject headings
- HIV Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
identification of the first HIV-infected cells by a histological analysis
Measured: after surgery, up to 3 weks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2015 (estimated)
- Study startNov 2015
- Primary completionNov 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV Infection of the Uterine Vaginal TissuesStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeanine OHL, MD, Principal investigator, University Hospital, Strasbourg, FranceChristiane OHL, PhD, Study director, UNISTRA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02481622
- Sponsor's protocol ID
- 6197
- Status last verified
- Nov 2015
- First submitted
- 7 Jun 2015
- Last updated
- 24 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhibition by the Antibody, First Event of Infection by HIV-1 of Uterine Vaginal Tissue
- ClinicalTrials.gov ID
- NCT02481622
- Acronym / sponsor ID
- 6197
- Keywords
- HIV infection, vaginal tissues, uterine tissues
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 25 Jun 2015 (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.
This non-interventional study aims to characterize the cells infected with HIV over time in different types of vagino-uterine tissue.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women whose age ≤50 years and ≥18 years, for which surgery type laparoscopy or hysterectomy is necessary as part of a benign pathology.
Key inclusion criteria (2 listed)
- Patients whose age ≤50 years and ≥18 years
- Patients for which surgery like laparoscopy or hysterectomy is necessary as part of a benign pathology.
Key exclusion criteria (1 listed)
- Patients under 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
identification of the first HIV-infected cells by a histological analysis
Time frame: after surgery, up to 3 weks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2017.
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.
Jeanine OHL, MD principal investigator
University Hospital, Strasbourg, France
Christiane OHL, PhD study director
UNISTRA
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 HIV Infection of the Uterine Vaginal Tissues, run by University Hospital, Strasbourg, France at 1 site in France.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 24 Apr 2017. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeanine OHL, MD (33 3 3 88 11 67 68, jeanine.ohl@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
identification of the first HIV-infected cells by a histological analysis (time frame: after surgery, up to 3 weks). 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 24 Apr 2017.