First Event of Infection by HIV-1 of Uterine Vaginal Tissue | NCT02481622

Studies
First Event of Infection by HIV-1 of Uterine Vaginal Tissue

NCT02481622

Sponsor

University Hospital, Strasbourg, France

Status

Unknown status

Last Update Posted

Apr 24, 2017Actual

Enrollment

600Estimated

Phase

Not provided

Conditions

HIV Infection of the Uterine Vaginal Tissues

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2015Actual

Primary Completion Date

Nov 2019Estimated

Completion Date

Nov 2019Estimated

First Submitted Date

Jun 7, 2015

First Submission Date that Met QC Criteria

Jun 24, 2015

First Posted Date

Jun 25, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2017

Last Update Posted Date

Apr 24, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This non-interventional study aims to characterize the cells infected with HIV over time in different types of vagino-uterine tissue.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

600Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
identification of the first HIV-infected cells by a histological analysis		after surgery, up to 3 weks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients whose age ≤50 years and ≥18 years
Patients for which surgery like laparoscopy or hysterectomy is necessary as part of a benign pathology.

Exclusion Criteria:

Patients under 18 years

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jeanine OHL, MD	Contact	33 3 3 88 11 67 68		jeanine.ohl@chru-strasbourg.fr
Christiane MOOG, PhD	Contact	33 3 68 85 37 42		c.moog@unistra.fr

Overall Officials

Name	Affiliation	Role
Jeanine OHL, MD	University Hospital, Strasbourg, France	Principal Investigator
Christiane OHL, PhD	UNISTRA	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
INSERM U1109 - Institut de Virologie 3, rue Koeberlé - 67000 Strasbourg	Recruiting	Strasbourg		67091	France

Condition Browse Module

MeSH Terms

ID	Term
D015658	HIV Infections

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral

Browse Leaves

Not provided

Browse Branches

Not provided