Trial Outcomes & Findings for Study of the Effect of Atorvastatin for Reducing Aging-related Complication in HIV-infected Patients Older Than 45 Years Receiving a Protease Inhibitor-based Regimen Versus a Raltegravir-based Regimen (NCT NCT02577042)

Results Overview

Switching the PI by raltegravir, plus Kivexa or Truvada for 24 weeks. After that, atorvastatin, 20mg/day has been added for 48 weeks. (intergroup and intragroup)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

42 participants

Primary outcome timeframe

baseline, wk24 and wk72

Results posted on

2020-10-29

Participant Flow

Participant milestones

Participant milestones
Measure	Raltegravir + Atorvastatin Switching the PI by raltegravir, plus Kivexaâ or Truvada, for 24 weeks. After that, atorvastatin, 20mg/day, will be added for 48 weeks Raltegravir: Switching the PI by raltegravir 400mg every 12 hours, plus Kivexa or Truvada, for 24 weeks. Atorvastatin: Atorvastatin, 20mg/day, will be added after 24 weeks of study for 48 weeks	PI-based Regimen + Atorvastatin Continue with the same PI-based regimen, plus Kivexa or Truvada, for 24 weeks. After that, atorvastatin, 20mg/day, will be added for 48 weeks. PI-based regimen: Continue with the same PI-based regimen, plus Kivexa or Truvada, for 24 weeks. Atorvastatin: Atorvastatin, 20mg/day, will be added after 24 weeks of study for 48 weeks
Overall Study STARTED	20	22
Overall Study COMPLETED	15	19
Overall Study NOT COMPLETED	5	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of the Effect of Atorvastatin for Reducing Aging-related Complication in HIV-infected Patients Older Than 45 Years Receiving a Protease Inhibitor-based Regimen Versus a Raltegravir-based Regimen

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Raltegravir + Atorvastatin n=20 Participants Switching the PI by raltegravir, plus Kivexaâ or Truvada, for 24 weeks. After that, atorvastatin, 20mg/day, will be added for 48 weeks Raltegravir: Switching the PI by raltegravir 400mg every 12 hours, plus Kivexa or Truvada, for 24 weeks. Atorvastatin: Atorvastatin, 20mg/day, will be added after 24 weeks of study for 48 weeks	PI-based Regimen + Atorvastatin n=22 Participants Continue with the same PI-based regimen, plus Kivexa or Truvada, for 24 weeks. After that, atorvastatin, 20mg/day, will be added for 48 weeks. PI-based regimen: Continue with the same PI-based regimen, plus Kivexa or Truvada, for 24 weeks. Atorvastatin: Atorvastatin, 20mg/day, will be added after 24 weeks of study for 48 weeks	Total n=42 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	20 Participants n=5 Participants	22 Participants n=7 Participants	42 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	49.5 years STANDARD_DEVIATION 3.5 • n=5 Participants	51.8 years STANDARD_DEVIATION 8.2 • n=7 Participants	50.65 years STANDARD_DEVIATION 5.85 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	17 Participants n=7 Participants	35 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants	22 Participants n=7 Participants	42 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Spain	20 participants n=5 Participants	22 participants n=7 Participants	42 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline, wk24 and wk72

Switching the PI by raltegravir, plus Kivexa or Truvada for 24 weeks. After that, atorvastatin, 20mg/day has been added for 48 weeks. (intergroup and intragroup)

Outcome measures

Outcome measures
Measure	Raltegravir + Atorvastatin n=20 Participants Switching the PI by raltegravir, plus Kivexaâ or Truvada, for 24 weeks. After that, atorvastatin, 20mg/day, will be added for 48 weeks Raltegravir: Switching the PI by raltegravir 400mg every 12 hours, plus Kivexa or Truvada, for 24 weeks. Atorvastatin: Atorvastatin, 20mg/day, will be added after 24 weeks of study for 48 weeks	PI-based Regimen + Atorvastatin n=22 Participants Continue with the same PI-based regimen, plus Kivexa or Truvada, for 24 weeks. After that, atorvastatin, 20mg/day, will be added for 48 weeks. PI-based regimen: Continue with the same PI-based regimen, plus Kivexa or Truvada, for 24 weeks. Atorvastatin: Atorvastatin, 20mg/day, will be added after 24 weeks of study for 48 weeks
Changes in the Inflammatory Marker IL-6 Baseline	42.5 pg/mL Interval 34.5 to 50.1	40.0 pg/mL Interval 36.9 to 53.7
Changes in the Inflammatory Marker IL-6 week 24	39.3 pg/mL Interval 34.6 to 49.8	41.1 pg/mL Interval 36.1 to 53.2
Changes in the Inflammatory Marker IL-6 week 72	43.2 pg/mL Interval 36.8 to 52.9	41.7 pg/mL Interval 34.7 to 51.5

PRIMARY outcome

Timeframe: baseline, wk24 and wk72

Changes in plasma soluble markers (D-dimer)