Prognosis of a First-Ever Stroke in Persons Living With HIV

HIV Clinical Trial

— PROFES  

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02748252
• Other study ID #: AMR_2014-3
• Status: Terminated
• Start date: December 2015
• Est. completion date: December 2016

Study information

• Verified date: August 2018
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

With aging of the persons living with HIV, cardiovascular diseases now account for substantial mortality and morbidity. Stroke frequency grows exponentially with aging and its incidence doubles every decade over 55 years of age.

The prognosis of ischemic stroke depends mainly on the care in Stroke Units in the acute phase of the disease (thrombolysis/thrombectomy). It is important that HIV patients are referred to these units in the first hours of a stroke and not to their infectious disease units which is a loss of chance.

It would also be important to know whether HIV patients need specific protocols for stroke emergency management.

The study aims to compare the functional prognosis after the first occurrence of an ischemic stroke, in patients admitted to a Stroke Unit, whether they are infected or not infected by HIV.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients unexposed to HIV: HIV-1 seronegative OR patients exposed to HIV: HIV seropositive for over 6 months with or without antiretroviral treatment. Confirmed by Elisa and Western blot tests

• admitted for ischemic stroke, defined as a sudden cerebrovascular event confirmed by MRI

• at least 18 years of age

• paired with patients unexposed to HIV, admitted for ischemic stroke, same gender and age

Exclusion Criteria:

• antecedents of a symptomatic ischemic or hemorrhagic cerebrovascular event

• no social security benefits;

• Absence of signed informed consent for the study

• Patients currently pregnant or breast-feeding

Related Conditions & MeSH terms

• Cerebrovascular Accident, Acute
• HIV
• Stroke

Intervention

Other:
• stroke center referral

Locations

Country	Name	City	State
France	Fondation Ophtalmologique Adolphe de Rothschild (FOR)	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	degree of disability measured with the modified Rankin Scale		3 months