Exploratory Study of Cellular Reservoirs in Blood From HI... | NCT02858414

Studies
Exploratory Study of Cellular Reservoirs in Blood From HIV Infected Patients

NCT02858414

Sponsor

Centre Hospitalier Universitaire de Besancon

Status

Completed

Last Update Posted

Dec 6, 2018Actual

Enrollment

41Actual

Phase

Not Applicable

Conditions

HIV Infection

Interventions

additional blood sample

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

Dec 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2, 2015Actual

Primary Completion Date

Oct 4, 2017Actual

Completion Date

Oct 4, 2017Actual

First Submitted Date

Jul 29, 2016

First Submission Date that Met QC Criteria

Aug 3, 2016

First Posted Date

Aug 8, 2016Estimated

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

Dec 5, 2018

Last Update Posted Date

Dec 6, 2018Actual

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 study evaluates the impact of highly active antiretroviral therapy on the size of the latent viral reservoirs in resting CD4+ T cells and monocytes in HIV positive patients. The activation state of the cells will be assessed, by measuring the activation of Akt, to determine its influence on the size of the viral reservoirs.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

41Actual

Label	Type	Description	Intervention Names
blood sample	Experimental		Other: additional blood sample

Name	Type	Description	Arm Group Labels	Other Names
additional blood sample	Other		blood sample

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measure of the integrated viral reservoir size	Measure by Alu-PCR. Results are given in number of integrated proviral DNA copies per 1 million cells.	day 1
Measure of the proviral reservoir size	Measure by Total Proviral HIV DNA detection kit. Results are given in number of total proviral DNA copies per 1 million cells.	day 1

Secondary Outcomes

Measure	Description	Time Frame
Measure of Akt activation	Measure of Akt activation in live cells by flow cytometry	day 1

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

HIV infected patients under Highly Active Anti-Retroviral Therapy (HAART) or Naïve from treatment

Exclusion Criteria:

Age limits
Pregnancy
Legal restrictions to consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Georges HERBEIN, MD-PhD	Centre Hospitalier Universitaire de Besancon	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier Régional Universitaire		Besançon		25030	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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