Trial Outcomes & Findings for The Safety, Pharmacokinetic Profile and Efficacy of Raltegravir in HIV-infected Patients at Least 60 Years of Age (NCT NCT01335620)

NCT ID: NCT01335620

Last Updated: 2019-11-20

Results Overview

rategravir concentration

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

19 participants

Primary outcome timeframe

Day 28

Results posted on

2019-11-20

Participant Flow

Participant milestones

Participant milestones
Measure	Truvada Plus Raltegravir Single arm study Raltegravir: 400 mg twice daily
Overall Study STARTED	19
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Safety, Pharmacokinetic Profile and Efficacy of Raltegravir in HIV-infected Patients at Least 60 Years of Age

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Truvada Plus Raltegravir n=19 Participants Single arm study Raltegravir: 400 mg twice daily
Age, Continuous	66 years STANDARD_DEVIATION 3.4 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United Kingdom	19 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 28

rategravir concentration

Outcome measures

Outcome measures
Measure	Truvada Plus Raltegravir n=19 Participants Single arm study Raltegravir: 400 mg twice daily
Drug Levels in Blood	1732 ng/ml Interval 969.0 to 3095.0

PRIMARY outcome

Timeframe: 6 months

Population: No data collected

full blood count, electrolytes and blood lipids will be measured at all visits to assess for changes through out the study. HIV viral load will also be measured to assess the efficacy of the medication at controlling the virus

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: No data collected

• To investigate cardiovascular disease markers before and after a switch in antiretroviral therapy to raltegravir.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Cerebral function via cognitive testing before and after a switch in antiretroviral therapy to raltegravir. Mean Scores from the eight tasks (NPZ-8) assessed were used to derive a global composite measure of neurocognitive function. The result shows the change before and after switch, an increase in z-score represents an improvement in cognitive function assessed by CogState battery, required approximately 10-15 min for completion.

Outcome measures

Outcome measures
Measure	Truvada Plus Raltegravir n=19 Participants Single arm study Raltegravir: 400 mg twice daily
Cerebral Function; Changes in Global Cognitive Z-score	0.91 score on a scale Standard Deviation 1.3

Adverse Events

Truvada Plus Raltegravir

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Alan Winston

Imperial College London

Phone: +442033121603

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place