Longitudinal Therapeutically Non-interventional Study of MSRV-Env Burden in Normal Population

A One Year Longitudinal Therapeutically Non-Interventional Study of MSRV-Env Burden in Normal Population as Assessed by PCR and ELISA in Blood

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01804660

Acronym

CONTROL

Enrollment

Registered

2013-03-05

Start date

2012-10-31

Completion date

2013-12-31

Last updated

2020-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis (MS), Multiple Sclerosis associated RetroVirus (MSRV), MSRV envelop protein (MSRV-Env), Temelimab

Brief summary

This study intends to explore the levels of MSRV expression by analyzing the levels of MSRV transcripts in blood, as well as the levels of the MSRV-Env protein in serum in the normal population. This study is important for establishing a baseline to analyze results obtained in MS patients (another dedicated study is performed in parallel in MS patients). The study will be conducted over one year in a cohort of healthy subjects. The MSRV RNA level, MSRV-Env protein levels, reverse transcriptase activity, inflammatory markers assessed by cytokines levels will be analysed to define control levels in the normal population and their variation during one year. The data obtained in this study in healthy controls will be compared to those obtained in a parallel similar study, GN-E-002, conducted in different types of MS patients.

Interventions

OTHERNo study treatments administered

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

* Signature of an informed consent; * Male or female between 18 and 60 years of age.

Exclusion criteria

* Positive serology for hepatitis B or C or HIV; * Acute infection at inclusion; * Severe psychiatric disorder, neurological, inflammatory, or autoimmune disease; * Pregnancy or breastfeeding; * Heavy smokers i.e. more than 10 cigarettes per day; * History of alcohol or drug abuse in the last 3 years; * Participation in a clinical trial (within the last 3 months).

Design outcomes

Primary

Measure	Time frame	Description
Establish a control value for the levels of MSRV expression in the normal population over time	1 year	Establish a control value for the levels of MSRV expression in the normal population over time using 3 approaches: * MSRV transcripts in PBMC; * MSRV transcripts in plasma; * MSRV-Env protein in serum.

Secondary

Measure	Time frame
Inflammatory markers and reverse transcriptase activity in blood.	1 year

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026