Trial Outcomes & Findings for Changes in Lipids and Lipoproteins in HIV Infected Women After Switch From Protease Inhibitor to Raltegravir (NCT NCT02097108)

NCT ID: NCT02097108

Last Updated: 2016-09-13

Results Overview

A reduction of \> 5% in the plasma concentration of direct LDL cholesterol from baseline to week 12 or \> 10% reduction of total cholesterol or reduction of lipid lowering agents is expected. Reduction of lipid lowering agents is defined as reduction due to amelioration of lipid profiles and does not include reduction due to side effects or other toxicity issues.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 11 participants
• Primary outcome timeframe: baseline to week 12
• Results posted on: 2016-09-13

Participant Flow

11 patients were enrolled at 3 sites in Austria. First patient in was 15.05.2014; last patient in was 23.06.2015.

Participant milestones

Measure	Raltegravir Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy. Raltegravir
Overall Study STARTED	11
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Raltegravir Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy. Raltegravir
Overall Study Adverse Event	1
Overall Study patient was abroad for 6 months	1

Baseline Characteristics

Changes in Lipids and Lipoproteins in HIV Infected Women After Switch From Protease Inhibitor to Raltegravir

Baseline characteristics by cohort

Measure	Raltegravir n=11 Participants Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy. Raltegravir
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline to week 12

Population: all patients

A reduction of > 5% in the plasma concentration of direct LDL cholesterol from baseline to week 12 or > 10% reduction of total cholesterol or reduction of lipid lowering agents is expected. Reduction of lipid lowering agents is defined as reduction due to amelioration of lipid profiles and does not include reduction due to side effects or other toxicity issues.

Outcome measures

Measure	Raltegravir n=11 Participants Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy. Raltegravir
Patients With Low-density Lipoprotein (LDL) Cholesterol Reduction	90.9 percentage of participants Interval 58.7 to 99.8

SECONDARY outcome

Timeframe: baseline to week 24

Outcome measures

Measure	Raltegravir n=11 Participants Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy. Raltegravir
Total Cholesterol Baseline and After 24 Weeks Baseline	247.55 mg/dl Standard Deviation 21.07
Total Cholesterol Baseline and After 24 Weeks 24 weeks	215.7 mg/dl Standard Deviation 28.55

SECONDARY outcome

Timeframe: baseline to week 24

Outcome measures

Measure	Raltegravir n=11 Participants Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy. Raltegravir
Triglycerides Baseline and After 24 Weeks Baseline	168.45 mg/dl Standard Deviation 57.08
Triglycerides Baseline and After 24 Weeks 24 weeks	83.3 mg/dl Standard Deviation 28.94

SECONDARY outcome

Timeframe: baseline to week 24

Outcome measures

Measure	Raltegravir n=11 Participants Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy. Raltegravir
High-density Lipoprotein (HDL) Cholesterol Baseline and After 24 Weeks Baseline	58 mg/dl Standard Deviation 14.09
High-density Lipoprotein (HDL) Cholesterol Baseline and After 24 Weeks 24 weeks	64 mg/dl Standard Deviation 12.75

Adverse Events

Raltegravir

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Raltegravir n=11 participants at risk Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy. Raltegravir
Gastrointestinal disorders Abdominal pain	9.1% 1/11 • Number of events 1 • 19 months All (serious) adverse events occuring during study treatment were collected until 28 days after the end of study treatment.

Other adverse events

Measure	Raltegravir n=11 participants at risk Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy. Raltegravir
Gastrointestinal disorders Abdominal pain	9.1% 1/11 • Number of events 1 • 19 months All (serious) adverse events occuring during study treatment were collected until 28 days after the end of study treatment.
Gastrointestinal disorders Constipation	9.1% 1/11 • Number of events 1 • 19 months All (serious) adverse events occuring during study treatment were collected until 28 days after the end of study treatment.
General disorders Pyrexia	9.1% 1/11 • Number of events 1 • 19 months All (serious) adverse events occuring during study treatment were collected until 28 days after the end of study treatment.
Investigations Aspartate aminotransferase increased	9.1% 1/11 • Number of events 1 • 19 months All (serious) adverse events occuring during study treatment were collected until 28 days after the end of study treatment.
Investigations Alanine aminotransferase increased	9.1% 1/11 • Number of events 1 • 19 months All (serious) adverse events occuring during study treatment were collected until 28 days after the end of study treatment.
Investigations Gamma-glutamyltransferase increased	9.1% 1/11 • Number of events 1 • 19 months All (serious) adverse events occuring during study treatment were collected until 28 days after the end of study treatment.
Nervous system disorders Headache	9.1% 1/11 • Number of events 1 • 19 months All (serious) adverse events occuring during study treatment were collected until 28 days after the end of study treatment.
Renal and urinary disorders Dysuria	9.1% 1/11 • Number of events 1 • 19 months All (serious) adverse events occuring during study treatment were collected until 28 days after the end of study treatment.
Respiratory, thoracic and mediastinal disorders Cough	9.1% 1/11 • Number of events 1 • 19 months All (serious) adverse events occuring during study treatment were collected until 28 days after the end of study treatment.
Skin and subcutaneous tissue disorders Alopecia	9.1% 1/11 • Number of events 1 • 19 months All (serious) adverse events occuring during study treatment were collected until 28 days after the end of study treatment.

Additional Information

Public contact Daniela Wolkersdorfer

AGMT

Phone: 00436626404411

Email: d.wolkersdorfer@agmt.at

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER