The CNS Integrase Inhibitor Study

The Central Nervous System Effects of Two Different HIV-Integrase Inhibitor Containing Antiretroviral Regimens. - The CNS Integrase Inhibitor Study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-003710-84-GB

Enrollment

Registered

2014-11-04

Start date

2014-11-27

Completion date

Unknown

Last updated

2019-06-30

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

Conditions

Human Immunodificiency Virus

Interventions

Trade Name: Tivicay Product Name: Tivicay Pharmaceutical Form: Film-coated tablet Trade Name: Isentress Product Name: Isentress

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: HIV-1 infected subjects Signed informed consent No contraindication to lumbar puncture examination on screening MRI of brain. Plasma HIV RNA 4 months comprising of: raltegravir 400mg twice daily tenofovir 245 mg daily emtricitabine 200 mg daily Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2

Exclusion criteria

Exclusion criteria: Existing neurological disease Current history of major depression or psychosis Recent head injury (past three months) Current alcohol abuse or drug dependence Active opportunistic infection or significant co-morbidities Pregnancy

Design outcomes

Primary

Measure	Time frame
Timepoint(s) of evaluation of this end point: At the end of the trial when all samples have been analysed; Main Objective: The aim of the study is to compare cerebral function parameters in HIV-infected subjects receiving two different integrase-inhibitor containing antiretroviral regimens by assessing the following questions: -Principal research question: • Changes in neurocognitive function between study treatment arms. ; Secondary Objective: • Changes in cerebral biomarkers measured on CSF between study treatment arms. • Differences and changes in CSF infectivity assays between study treatment arms. • Differences and changes in cerebral imaging markers between study treatment arms. • The proportion of subjects with a CSF HIV RNA < 5 copies/mL. • Differences in changes of CNS metabolites after 120 days of treatment. • The CSF exposure and CSF:plasma ratio of dolutegravir and raltegravir. ; Primary end point(s): The aim of the study is to compare cerebral function parameters in HIV-infected subjects receiving two different integrase-inhibitor containing antiretroviral regimens by assessing the following questions: -Principal research question: • Changes in neurocognitive function between study treatment arms.	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: At the end of the trial when all samples have been analysed; Main Objective: The aim of the study is to compare cerebral function parameters in HIV-infected subjects receiving two different integrase-inhibitor containing antiretroviral regimens by assessing the following questions: -Principal research question: • Changes in neurocognitive function between study treatment arms. ; Secondary Objective: • Changes in cerebral biomarkers measured on CSF between study treatment arms. • Differences and changes in CSF infectivity assays between study treatment arms. • Differences and changes in cerebral imaging markers between study treatment arms. • The proportion of subjects with a CSF HIV RNA < 5 copies/mL. • Differences in changes of CNS metabolites after 120 days of treatment. • The CSF exposure and CSF:plasma ratio of dolutegravir and raltegravir. ; Primary end point(s): The aim of the study is to compare cerebral function parameters in HIV-infected subjects receiving two different integrase-inhibitor containing antiretroviral regimens by assessing the following questions: -Principal research question: • Changes in neurocognitive function between study treatment arms.

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: At the end of the trial when all samples have been analysed; Secondary end point(s): • Changes in cerebral biomarkers measured on CSF between study treatment arms. • Differences and changes in CSF infectivity assays between study treatment arms. • Differences and changes in cerebral imaging markers between study treatment arms. • The proportion of subjects with a CSF HIV RNA < 5 copies/mL. • Differences in changes of CNS metabolites after 120 days of treatment. • The CSF exposure and CSF:plasma ratio of dolutegravir and raltegravir.	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: At the end of the trial when all samples have been analysed; Secondary end point(s): • Changes in cerebral biomarkers measured on CSF between study treatment arms. • Differences and changes in CSF infectivity assays between study treatment arms. • Differences and changes in cerebral imaging markers between study treatment arms. • The proportion of subjects with a CSF HIV RNA < 5 copies/mL. • Differences in changes of CNS metabolites after 120 days of treatment. • The CSF exposure and CSF:plasma ratio of dolutegravir and raltegravir.

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Countries

United Kingdom

Contacts

Public ContactKen Legg

Imperial College London

k.legg@imperial.ac.uk020 3312 1464

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026