Prediction and Pathogenesis of the Immune Reconstitution... | NCT01557803

Studies
Prediction and Pathogenesis of the Immune Reconstitution Inflammatory Syndrome

NCT01557803

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status

Completed

Last Update Posted

Jan 14, 2015Estimated

Enrollment

107Actual

Phase

Not provided

Conditions

Immune Reconstitution Inflammatory Syndrome
Opportunistic Infections

Interventions

Not provided

Countries

Gabon

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

Jan 2015

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

Jan 2012

Primary Completion Date

Feb 2014Actual

Completion Date

Jan 2015Actual

First Submitted Date

Mar 16, 2012

First Submission Date that Met QC Criteria

Mar 19, 2012

First Posted Date

Mar 20, 2012Estimated

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

Jan 13, 2015

Last Update Posted Date

Jan 14, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

S. Janssen, MD, MSc, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Principal Investigator

Lead Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)OTHER

Collaborators

Name	Class
University Hospital Tuebingen	OTHER
Albert Schweitzer Hospital	OTHER

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

The objective of this project is to determine clinical and biological predictors of Immune Reconstitution Inflammatory Syndrome (IRIS) occurrence in HIV infected patients who are started on antiretroviral therapy (ART), and to obtain more insight into the pathogenesis of this syndrome. The investigators will prospectively study HIV infected patients in Sub Saharan Africa who will be initiated on ART and are at risk to develop IRIS in all its different appearances. In these patients, the investigators will assess the value of clinical features and plasma biomarkers to predict IRIS, and the investigators will obtain insight into which inflammatory pathways become activated during IRIS. This project will provide novel knowledge about this clinically highly relevant healthcare problem in a resource poor setting, namely in Lambaréné, Gabon, in the Central African rainforest belt. In Gabon little research has been done in the field of HIV. The epidemiological pattern of IRIS in Gabon will be described. Promising putative plasma biomarkers will be validated for their use in daily practice.

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

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

107Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Starting ART		Adult patients starting anti retroviral therapy for the first time

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
IRIS	Development of immune reconstitution inflammatory syndrome	12 months

Secondary Outcomes

Measure	Description	Time Frame
Time to IRIS	Time to development of immune reconstitution inflammatory syndrome	12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age > 18 years
Informed consent
ART naive

Exclusion Criteria:

No informed consent
History of ART use
Pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult HIV patients starting anti retroviral therapy for the first time

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
MP Grobusch, MD, MSc	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical Research Unit - Albert Schweitzer Hospital		Lambaréné	Moyen Ogoué	BP118	Gabon

Condition Browse Module

MeSH Terms

ID	Term
D054019	Immune Reconstitution Inflammatory Syndrome
D009894	Opportunistic Infections

Ancestor Terms

ID	Term
D007154	Immune System Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided