Trial Outcomes & Findings for Atripla to Raltegravir Switch Study for CNS Toxicity (NCT NCT01195467)

Results Overview

To assess the rate of neuropsychiatric and central nervous system (CNS) toxicity as measured from baseline to 4 weeks of raltegravir therapy as measured by sleep questionnaire \& CNS toxicity (as determined by questionnaire based on efavirenz SPC and graded based on the ACTG adverse event scale)

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

40 participants

Primary outcome timeframe

4 weeks

Results posted on

2014-11-26

Participant Flow

Participant milestones

Participant milestones
Measure	Single Arm No randomisation as this is a single arm trial. All subjects switched from one tablet once daily of Atripla to Truvada at baseline and trested for 12 weeks.
Overall Study STARTED	40
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Atripla to Raltegravir Switch Study for CNS Toxicity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm n=40 Participants No randomisation as this is a single arm trial. All subjects switched from one tablet once daily of Atripla to Truvada at baseline and trested for 12 weeks.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants
Region of Enrollment United Kingdom	40 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

To assess the rate of neuropsychiatric and central nervous system (CNS) toxicity as measured from baseline to 4 weeks of raltegravir therapy as measured by sleep questionnaire \& CNS toxicity (as determined by questionnaire based on efavirenz SPC and graded based on the ACTG adverse event scale)

Outcome measures

Outcome measures
Measure	Single Arm n=40 Participants No randomisation as this is a single arm trial. All subjects switched from one tablet once daily of Atripla to Truvada at baseline and treated for 12 weeks.
The Rate of Neuropsychiatric and Central Nervous System (CNS) Toxicity of Raltegravir Therapy After 4 Weeks on Treatment	26 percentage improvement in CNS score

SECONDARY outcome

Timeframe: baseline to week 12

The rate of neuropsychiatric and central nervous system (CNS) toxicity as measured after 12 weeks of raltegravir therapy as measured by : * Sleep questionnaire * CNS toxicity (as determined by questionnaire based on efavirenz SPC and graded based on the ACTG adverse event scale)

Outcome measures

Outcome measures
Measure	Single Arm n=40 Participants No randomisation as this is a single arm trial. All subjects switched from one tablet once daily of Atripla to Truvada at baseline and treated for 12 weeks.
The Rate of Neuropsychiatric and Central Nervous System (CNS) Toxicity of Raltegravir Therapy After 12 Weeks on Treatment	25 percentage of improvement in sleep score

SECONDARY outcome

Timeframe: baseline to week 12

Change from baseline to week 12 in CD4+ count after 12 weeks of raltegravir having switched from efavirenz-containing therapy

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: week 4 to week 12

To assess the proportion of patients with viral load \< 50 copies/mL and \<400 copies/ml at weeks 4 and 12 after switching to raltegravir

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: week 4 to week 12

To assess the change in fasting lipids (total cholesterol and subfractions and triglycerides) after 4 and 12 weeks of raltegravir

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline to week 12

To assess the proportion of patients with grade 2-4 laboratory parameters (excluding lipids) after 12 weeks of raltegravir compared with baseline

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline to week 12

To assess the proportion of patients with grade 2-4 non-CNS adverse events after 12 weeks of raltegravir compared with baseline

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline to week 12

To assess the change from baseline in adherence from baseline after 12 weeks of raltegravir as measured by the adherence questionnaire: Medication Adherence Self-Report Inventory (M-MASRI)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline to week 12

To assess the change from baseline of CNS toxicity as measured by Hospital Anxiety and Depression (HADS) score (baseline vs week 12)

Outcome measures

Outcome data not reported

Adverse Events

Single Arm

Serious events: 4 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Single Arm n=40 participants at risk No randomisation as this is a single arm trial. All subjects switched from one tablet once daily of Atripla to Truvada at baseline and treated for 12 weeks.
Blood and lymphatic system disorders Thombosed haemorrhoids	2.5% 1/40 • Number of events 1 • 5 months From date of informed consent to date of follow up visit
Psychiatric disorders Deliberate overdose	2.5% 1/40 • Number of events 1 • 5 months From date of informed consent to date of follow up visit
Nervous system disorders Peripheral neuropathy	2.5% 1/40 • Number of events 1 • 5 months From date of informed consent to date of follow up visit
Renal and urinary disorders Groin pain	2.5% 1/40 • Number of events 1 • 5 months From date of informed consent to date of follow up visit

Other adverse events

Other adverse events
Measure	Single Arm n=40 participants at risk No randomisation as this is a single arm trial. All subjects switched from one tablet once daily of Atripla to Truvada at baseline and treated for 12 weeks.
Musculoskeletal and connective tissue disorders Bilateral Arm Pain	2.5% 1/40 • 5 months From date of informed consent to date of follow up visit
Skin and subcutaneous tissue disorders Ichthyosis	2.5% 1/40 • 5 months From date of informed consent to date of follow up visit
Renal and urinary disorders Haematuria	2.5% 1/40 • 5 months From date of informed consent to date of follow up visit
Renal and urinary disorders Renal Colic	2.5% 1/40 • 5 months From date of informed consent to date of follow up visit
Skin and subcutaneous tissue disorders Cellulitis	2.5% 1/40 • 5 months From date of informed consent to date of follow up visit
Ear and labyrinth disorders Tinnitus	2.5% 1/40 • 5 months From date of informed consent to date of follow up visit
Gastrointestinal disorders Diarrhoea	2.5% 1/40 • 5 months From date of informed consent to date of follow up visit
Nervous system disorders Night Sweats	2.5% 1/40 • 5 months From date of informed consent to date of follow up visit

Additional Information

Dr Mark Nelson

St Stephen's AIDS Trust

Phone: 02033

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place