Trial Outcomes & Findings for A Study of the Neurological Effects of Adding Raltegravir to HAART Regimen in Patients With HIV (NCT NCT01448486)

Results Overview

Change in overall neurocognitive performance, defined as a global neurocognitive z-score, over the study time-period (baseline, 6-months, 12-months). To derive this score, 1) raw scores obtained from a 5-domain brief neurocognitive battery were converted to age-corrected z-scores (M=0, SD=1) and 2) the set of individual subtest z-scores were averaged to generate a single composite (global) z-score for each subject. Lower (negative) scores therefore indicate greater levels of cognitive impairment.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

6 participants

Primary outcome timeframe

Baseline, 6 months and 12 months

Results posted on

2016-06-27

Participant Flow

Recruitment period from October 2011 to October 2013. Participants were known patients of the PI or referred from local tertiary sexual health clinics by associate investigators.

Participant milestones

Participant milestones
Measure	Raltegravir Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART) with the addition of Raltegravir 400 mg twice daily (BID). Raltegravir : Oral raltegravir, 400 mg tablet, twice daily for one year.	Standard of Care HAART Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART).
Overall Study STARTED	3	3
Overall Study COMPLETED	3	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of the Neurological Effects of Adding Raltegravir to HAART Regimen in Patients With HIV

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Raltegravir n=3 Participants Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART) with the addition of Raltegravir 400 mg twice daily (BID). Raltegravir : Oral raltegravir, 400 mg tablet, twice daily for one year.	Standard of Care HAART n=3 Participants Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART).	Total n=6 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	52.0 years STANDARD_DEVIATION 8.7 • n=5 Participants	59.3 years STANDARD_DEVIATION 4.9 • n=7 Participants	55.7 years STANDARD_DEVIATION 7.5 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 6 months and 12 months

Population: Study was terminated prematurely with an incomplete study dataset any before any meaningful statistical analysis of the data (including change over the study time-points) could be performed.

Change in overall neurocognitive performance, defined as a global neurocognitive z-score, over the study time-period (baseline, 6-months, 12-months). To derive this score, 1) raw scores obtained from a 5-domain brief neurocognitive battery were converted to age-corrected z-scores (M=0, SD=1) and 2) the set of individual subtest z-scores were averaged to generate a single composite (global) z-score for each subject. Lower (negative) scores therefore indicate greater levels of cognitive impairment.

Outcome measures

Outcome measures
Measure	Raltegravir n=3 Participants Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART) with the addition of Raltegravir 400 mg twice daily (BID). Raltegravir : Oral raltegravir, 400 mg tablet, twice daily for one year.	Standard of Care HAART n=3 Participants Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART).
Neurocognitive Function Baseline	-0.83 Global Neurocognitive Z-Score Standard Error 0.29	-0.39 Global Neurocognitive Z-Score Standard Error 0.20
Neurocognitive Function 6 months	-0.55 Global Neurocognitive Z-Score Standard Error 0.12	-0.48 Global Neurocognitive Z-Score Standard Error 0.45
Neurocognitive Function 12 months	-0.47 Global Neurocognitive Z-Score Standard Error 0.46	-0.54 Global Neurocognitive Z-Score Standard Error 0.32

SECONDARY outcome

Timeframe: Baseline and 12 months

Population: Study was terminated prematurely with an incomplete study dataset before any meaningful analyses of the data could be conducted. CSF was not collected at 12 months for n=1 raltegravir and n=1 control who refused lumbar puncture.

To determine if there is improvement in CSF neopterin concentrations with the addition of Raltegravir.

Outcome measures

Outcome measures
Measure	Raltegravir n=3 Participants Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART) with the addition of Raltegravir 400 mg twice daily (BID). Raltegravir : Oral raltegravir, 400 mg tablet, twice daily for one year.	Standard of Care HAART n=3 Participants Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART).
Cerebrospinal Fluid Baseline	11.67 nmol/L Standard Error 2.91	34.00 nmol/L Standard Error 16.26
Cerebrospinal Fluid 12 months	17.00 nmol/L Standard Error 7.00	12.00 nmol/L Standard Error 3.00

Adverse Events

Raltegravir

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Standard of Care HAART

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Raltegravir n=3 participants at risk Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART) with the addition of Raltegravir 400 mg twice daily (BID). Raltegravir : Oral raltegravir, 400 mg tablet, twice daily for one year.	Standard of Care HAART n=3 participants at risk Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART).
General disorders Muscle strain	33.3% 1/3 • Number of events 1	0.00% 0/3
General disorders Flu-like illness	0.00% 0/3	33.3% 1/3 • Number of events 1
Metabolism and nutrition disorders Vitamin D deficiency	0.00% 0/3	33.3% 1/3 • Number of events 1

Additional Information

Prof. Bruce Brew

St. Vincent's Hospital, Sydney

Phone: 61 2 8382 1111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place