NCT02343887

Brief Summary

Despite undetectable plasma viral load under treatment, about 30% of HIV infected patients show asymptomatic neurocognitive impairment or minor cognitive disorder. These symptoms impact the compliance of the treatment, though its performance and daily life quality. To this day, no therapy tested has proved its efficiency, including the strategy of the antiretroviral therapy (cART) optimization according to the Cerebral Penetration effectiveness Score (CPE). Description of the study: an open prospective comparative monocentric pilote study, randomised in three groups which investigates the efficiency of a 6 months-cognitive rehabilitation program on improving asymptomatic or minor cognitive disorder for undetectable HIV+ patients. This study gathers HIV-1 patients undetectable under stable cART with a good cerebral penetration who develop asymptomatic or minor cognitive disorders connected to HIV infection. Those who have severe psychiatric disorder or who are on medication that could interfere with psychometrical tests will be excluded. Main Objective: to compare the impact of a cognitive rehabilitation program over a 6 months period on the evolution of minor cognitive disorders and asymptomatic patients to a control group and a group treated with psychological support.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for not_applicable hiv

Timeline
Completed

Started Nov 2014

Typical duration for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 22, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

October 23, 2015

Status Verified

October 1, 2015

Enrollment Period

2.2 years

First QC Date

November 14, 2014

Last Update Submit

October 22, 2015

Conditions

HIV

Outcome Measures

Primary Outcomes (4)

  • cognitive remediation strategy (BREF test)

    \- BREF test

    6 months

  • cognitive remediation strategy (grooved pegboard test)

    \- grooved pegboard test

    6 months

  • cognitive remediation strategy (RLRI-16 test6.)

    \- RLRI-16 test6.

    6 months

  • cognitive remediation strategy (Digit Symbol Substitution Test)

    \- Digit Symbol Substitution Test

    6 months

Secondary Outcomes (2)

  • impact on daily life quality (SF-12 Medical Outcomes Study Short-Form General Health Survey)

    6 months

  • impact on daily life quality (Trail Making Test)

    6 months

Study Arms (3)

control group

ACTIVE COMPARATOR

patients without taking into cognitive or psychological treatment for 6 months (period 1) and * if the situation improves in the neuropsychological assessment of M6 further with simple monitoring neuropsychological evaluation M12 * or persistence or worsening of the disorder, the beginning of a cognitive remediation program for 6 months (period 2).

Other: neuropsychological testsOther: STAI-Y scale for anxietyOther: Beck scale for depressionOther: without intervention

group with cognitive rehabilitation,

EXPERIMENTAL

patients treated for 6 months Cognitive remediation (period 1), then * Stop if the situation improves in the evaluation and monitoring of M6 to M12 with neuropsychological assessment, * or persistence or worsening of the disorder, further cognitive remediation for 6 months (period 2).

Other: neuropsychological testsOther: STAI-Y scale for anxietyOther: Beck scale for depression

group with psychological support.

EXPERIMENTAL

patients treated with counseling for six months (period 1) and * Stop if the situation improves with neuropsychological assessment and monitoring to M12, * or if persistent or worsening unrest in the neuropsychological assessment of M6, the beginning of a cognitive remediation program for 6 months (period 2).

Other: neuropsychological testsOther: STAI-Y scale for anxietyOther: Beck scale for depression

Interventions

neuropsychological testsOTHER
control groupgroup with cognitive rehabilitation,group with psychological support.
STAI-Y scale for anxietyOTHER
control groupgroup with cognitive rehabilitation,group with psychological support.
Beck scale for depressionOTHER
control groupgroup with cognitive rehabilitation,group with psychological support.
without interventionOTHER
control group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \- Seropositive for HIV-1 Patient
  • With a plasma viral load below the limit of detection for minimum 6 months (HIV viral load \<40 copies / ml)
  • On stable antiretroviral therapy for 12 months, according to the revised optimized subject to the constraints of genotypic resistance and CPE score in the absence of cons-indication to treatment intensive brain penetration (Annex 15)
  • With cognitive complaint objectified by the cognitive complaint questionnaire (Appendix 9: score 3 or 1 positive response among the items C4, C5, C7, C8) and cognitive impairment found by an alteration of at least two cognitive fields assessed by psychometric tests for at least 6 months
  • \<age \<55 years
  • No defined by a marked depression scale score of Beck \<16 (Appendix 13)
  • No marked anxiety defined by a T score\> 55 on the scale of Spielberger STAI-Y (Annex 14)
  • Insured under the social security
  • Who signed the consent form.
  • Recent brain imaging excluding other causes of cognitive impairment (MRI or CT brain injected injected so-indication against MRI)

You may not qualify if:

  • A patient diagnosed and followed for more than six months psychiatric disorder that could interfere with psychometric assessment
  • Patients with a poor understanding of French,
  • Patients with active opportunistic infection of the CNS or with neurological sequelae.
  • History of head trauma
  • Active Substance excluding cannabis
  • Patient for which a change of antiretroviral therapy is provided within 12 months
  • Patient for which interferon treatment is provided within 12 months
  • Patient placed under guardianship,
  • Patient with HIV-related dementia
  • Liver cirrhosis Child B or C (Annex 16)
  • Severe renal impairment (creatinine clearance by Cockcroft \<30 ml / min)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, Paca, 13354, France

RECRUITING

MeSH Terms

Interventions

Neuropsychological TestsMethods

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and ActivitiesInvestigative Techniques

Study Officials

  • Urielle DESALBRES

    Assistance Publique Hopitaux De Marseille

    STUDY DIRECTOR

Central Study Contacts

Olivia ZAEGEL- FAUCHER

CONTACT

olivia.zaegel@ap-hm.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2014

First Posted

January 22, 2015

Study Start

November 1, 2014

Primary Completion

January 1, 2017

Study Completion

October 1, 2017

Last Updated

October 23, 2015

Record last verified: 2015-10

Locations

FR(1)