Trial Outcomes & Findings for Capacity of the Dual Combination Raltegravir/Etravirine to Maintain Virological Success in HIV-1 Infected Patients of at Least 45 Years of Age- ANRS 163 ETRAL (NCT NCT02212379)
NCT ID: NCT02212379
Last Updated: 2021-04-27
Results Overview
Virological success is defined as the absence of 2 consecutive plasma viral loads (VL) \> 50 copies/mL within 2 to 4 weeks of a dual raltegravir/etravirine regimen. The proportion of patients who maintained viral suppression under raltegravir plus etravirine was 99.4% (95% confidence interval (95% CI:95.6 -99.9) at week 48 and 98.7% (95% CI: 95.0 -99.7) at week 96
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
170 participants
Primary outcome timeframe
at week48 and at week 96
Results posted on
2021-04-27
Participant Flow
Between January and November 2015, 219 patients from 20 sites were screened and 170 patients were enrolled in the study.
Five patients did not initiate the trial treatment by their own decision, leaving 165 patients for the analysis.
Participant milestones
| Measure |
Raltegravir and Etravirine
raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.
Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.
|
|---|---|
|
From Baseline to Week 48
STARTED
|
165
|
|
From Baseline to Week 48
COMPLETED
|
156
|
|
From Baseline to Week 48
NOT COMPLETED
|
9
|
|
From Week 48 to Week 96
STARTED
|
156
|
|
From Week 48 to Week 96
COMPLETED
|
152
|
|
From Week 48 to Week 96
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Raltegravir and Etravirine
raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.
Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.
|
|---|---|
|
From Baseline to Week 48
Lack of Efficacy
|
1
|
|
From Baseline to Week 48
Adverse Event
|
7
|
|
From Baseline to Week 48
Withdrawal by Subject
|
1
|
|
From Week 48 to Week 96
Lack of Efficacy
|
1
|
|
From Week 48 to Week 96
Adverse Event
|
1
|
|
From Week 48 to Week 96
Withdrawal by Subject
|
2
|
Baseline Characteristics
Capacity of the Dual Combination Raltegravir/Etravirine to Maintain Virological Success in HIV-1 Infected Patients of at Least 45 Years of Age- ANRS 163 ETRAL
Baseline characteristics by cohort
| Measure |
Raltegravir and Etravirine
n=165 Participants
raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.
Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.
|
|---|---|
|
Age, Continuous
|
52 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
117 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
124 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Sub-saharan Africa
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Others
|
17 Participants
n=5 Participants
|
|
Transmission group
Men who have Sex with Men
|
66 Participants
n=5 Participants
|
|
Transmission group
Heterosexual
|
72 Participants
n=5 Participants
|
|
Transmission group
Others/Unknown
|
27 Participants
n=5 Participants
|
|
Time since HIV diagnosis
|
19.8 years
n=5 Participants
|
|
CDC stage C
|
36 Participants
n=5 Participants
|
|
CD4 nadir cell count
|
209 cells/mm^3
n=5 Participants
|
|
Hepatitis C co-infection
|
16 Participants
n=5 Participants
|
|
Antiretroviral treatment (ART) duration
|
16.9 years
n=5 Participants
|
|
Duration of suppressed HIV viremia (<50 copies/ml),
|
6.9 years
n=5 Participants
|
|
Duration of last combined antiretroviral therapy (cART)
|
58 Months
n=5 Participants
|
|
Antiretroviral treatment daily dosing
once daily
|
120 Participants
n=5 Participants
|
|
Antiretroviral treatment daily dosing
twice daily
|
45 Participants
n=5 Participants
|
|
cART at screening
2NRTIs + PI/r
|
107 Participants
n=5 Participants
|
|
cART at screening
NNRTI + PI/r
|
11 Participants
n=5 Participants
|
|
cART at screening
PI/r
|
35 Participants
n=5 Participants
|
|
cART at screening
Others
|
12 Participants
n=5 Participants
|
|
Comorbidities
Cardiovascular
|
8 Participants
n=5 Participants
|
|
Comorbidities
Dyslipidemia
|
53 Participants
n=5 Participants
|
|
Comorbidities
High blood pressure
|
45 Participants
n=5 Participants
|
|
Comorbidities
Diabetes
|
10 Participants
n=5 Participants
|
|
Active smoking
|
60 Participants
n=5 Participants
|
|
Former smokers
|
31 Participants
n=5 Participants
|
|
Alcohol use (>2 glasses/day)
|
14 Participants
n=5 Participants
|
|
CD4 cell count at screening
|
700 cells/mm^3
n=5 Participants
|
|
CD8 cell count at screening
|
678 cells/mm^3
n=5 Participants
|
|
CD4/CD8 ratio at screening
|
0.94 ratio
n=5 Participants
|
|
Total cholesterol
|
5.4 mmol/L
n=5 Participants
|
|
Non-HDL cholesterol
|
3.9 mmol/L
n=5 Participants
|
|
LDL cholesterol
|
3.2 mmol/L
n=5 Participants
|
|
HDL cholesterol
|
1.3 mmol/L
n=5 Participants
|
|
Triglycerides
|
1.3 mmol/L
n=5 Participants
|
|
Triglycerides/HDL ratio
|
1.0 ratio
n=5 Participants
|
|
Glycaemia
|
5.2 mmol/L
n=5 Participants
|
|
Estimated glomerular filtration rate (eGFR, CKD-EPI method)
|
93.9 mL/min/1.73 m^2
n=5 Participants
|
|
Body Mass Index (BMI)
|
24.3 kg/m^2
n=5 Participants
|
|
Waist circumference
|
92 cm
n=5 Participants
|
|
Hip circumference
|
95 cm
n=5 Participants
|
|
Waist/Hip ratio
|
0.97 ratio
n=5 Participants
|
|
Viruses with mutations that could potentially impact etravirine
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at week48 and at week 96Virological success is defined as the absence of 2 consecutive plasma viral loads (VL) \> 50 copies/mL within 2 to 4 weeks of a dual raltegravir/etravirine regimen. The proportion of patients who maintained viral suppression under raltegravir plus etravirine was 99.4% (95% confidence interval (95% CI:95.6 -99.9) at week 48 and 98.7% (95% CI: 95.0 -99.7) at week 96
Outcome measures
| Measure |
Raltegravir and Etravirine
n=165 Participants
raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.
Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.
|
Premenopausal With Reduced Ovarian Reserve
AMH\<0.02 ng/ml at inclusion in non-menopausal women who were classified as pre-menopausal
|
Postmenopausal
The menopausal status was recorded by the questionnaire at inclusion
|
|---|---|---|---|
|
Percentage of Participants With Successful Virological Suppression at Weeks 48 and 96
at week 48
|
99.4 percentage of participant
Interval 95.6 to 99.9
|
—
|
—
|
|
Percentage of Participants With Successful Virological Suppression at Weeks 48 and 96
at week 96
|
98.7 percentage of participant
Interval 95.0 to 99.7
|
—
|
—
|
SECONDARY outcome
Timeframe: weeks 48 and 96Therapeutic success was defined as the absence of virological failure (i.e. 2 consecutive plasma viral loads (VL) \> 50 copies/mL within 2 to 4 weeks) and the absence of treatment interruption due to adverse event judged by DSMB as related to the study treatment or procedure
Outcome measures
| Measure |
Raltegravir and Etravirine
n=165 Participants
raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.
Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.
|
Premenopausal With Reduced Ovarian Reserve
AMH\<0.02 ng/ml at inclusion in non-menopausal women who were classified as pre-menopausal
|
Postmenopausal
The menopausal status was recorded by the questionnaire at inclusion
|
|---|---|---|---|
|
Percentage of Patients With Therapeutic Success at Week 48 and Week 96
at week 48
|
95.1 percentage of participants
Interval 90.5 to 97.5
|
—
|
—
|
|
Percentage of Patients With Therapeutic Success at Week 48 and Week 96
at week 96
|
92.7 percentage of participants
Interval 87.5 to 95.8
|
—
|
—
|
SECONDARY outcome
Timeframe: weeks 48 and 96Outcome measures
| Measure |
Raltegravir and Etravirine
n=165 Participants
raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.
Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.
|
Premenopausal With Reduced Ovarian Reserve
AMH\<0.02 ng/ml at inclusion in non-menopausal women who were classified as pre-menopausal
|
Postmenopausal
The menopausal status was recorded by the questionnaire at inclusion
|
|---|---|---|---|
|
Percentage of Patients With Trial Treatment Interruption at Week 48 and Week 96
at week 48
|
4.3 percentage of participant
Interval 1.7 to 8.5
|
—
|
—
|
|
Percentage of Patients With Trial Treatment Interruption at Week 48 and Week 96
at week 96
|
6.1 percentage of participant
Interval 2.9 to 10.9
|
—
|
—
|
SECONDARY outcome
Timeframe: weeks 48 and 96Outcome measures
| Measure |
Raltegravir and Etravirine
n=165 Participants
raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.
Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.
|
Premenopausal With Reduced Ovarian Reserve
AMH\<0.02 ng/ml at inclusion in non-menopausal women who were classified as pre-menopausal
|
Postmenopausal
The menopausal status was recorded by the questionnaire at inclusion
|
|---|---|---|---|
|
Percentage of Patients With With Grade Virological Failure (HIV-RNA Plasma VL Between 51 and 200 Copies/mL)
at week 48
|
0 percentage of participants
Interval 0.0 to 2.2
|
—
|
—
|
|
Percentage of Patients With With Grade Virological Failure (HIV-RNA Plasma VL Between 51 and 200 Copies/mL)
at week 96
|
0.6 percentage of participants
Interval 0.01 to 3.3
|
—
|
—
|
SECONDARY outcome
Timeframe: week 96Time between the date of the study treatment initiation and the date of virological failure
Outcome measures
| Measure |
Raltegravir and Etravirine
n=165 Participants
raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.
Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.
|
Premenopausal With Reduced Ovarian Reserve
AMH\<0.02 ng/ml at inclusion in non-menopausal women who were classified as pre-menopausal
|
Postmenopausal
The menopausal status was recorded by the questionnaire at inclusion
|
|---|---|---|---|
|
Median Time of Virological Failure
|
96 weeks
Interval 1.0 to 96.0
|
—
|
—
|
SECONDARY outcome
Timeframe: weeks 48 and 96Outcome measures
| Measure |
Raltegravir and Etravirine
n=165 Participants
raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.
Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.
|
Premenopausal With Reduced Ovarian Reserve
AMH\<0.02 ng/ml at inclusion in non-menopausal women who were classified as pre-menopausal
|
Postmenopausal
The menopausal status was recorded by the questionnaire at inclusion
|
|---|---|---|---|
|
Percentage of Patients With High Grade of Virological Failure Defined as HIV RNA > 200 Copies/mL
week 48
|
0.6 percentage of participants
Interval 0.01 to 3.3
|
—
|
—
|
|
Percentage of Patients With High Grade of Virological Failure Defined as HIV RNA > 200 Copies/mL
week 96
|
0 percentage of participants
Interval 0.0 to 2.2
|
—
|
—
|
SECONDARY outcome
Timeframe: week 96Outcome measures
| Measure |
Raltegravir and Etravirine
n=2 Participants
raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.
Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.
|
Premenopausal With Reduced Ovarian Reserve
AMH\<0.02 ng/ml at inclusion in non-menopausal women who were classified as pre-menopausal
|
Postmenopausal
The menopausal status was recorded by the questionnaire at inclusion
|
|---|---|---|---|
|
Number of Patients With RAL and/or ETR Resistance Mutations Among Those With Virological Failure
|
1 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: week 96Outcome measures
| Measure |
Raltegravir and Etravirine
n=165 Participants
raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.
Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.
|
Premenopausal With Reduced Ovarian Reserve
AMH\<0.02 ng/ml at inclusion in non-menopausal women who were classified as pre-menopausal
|
Postmenopausal
The menopausal status was recorded by the questionnaire at inclusion
|
|---|---|---|---|
|
Factors Associated With the Occurrence of Plasma HIV-RNA Viral Load > 50 Copies/mL
Age >60 years
|
3.7 hazard ratio
Interval 1.4 to 10.1
|
—
|
—
|
|
Factors Associated With the Occurrence of Plasma HIV-RNA Viral Load > 50 Copies/mL
>=2 glasses/day alcohol consumption
|
11.3 hazard ratio
Interval 1.5 to 85.1
|
—
|
—
|
SECONDARY outcome
Timeframe: from day 0 to week 48 and week 96Outcome measures
| Measure |
Raltegravir and Etravirine
n=157 Participants
raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.
Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.
|
Premenopausal With Reduced Ovarian Reserve
AMH\<0.02 ng/ml at inclusion in non-menopausal women who were classified as pre-menopausal
|
Postmenopausal
The menopausal status was recorded by the questionnaire at inclusion
|
|---|---|---|---|
|
Evolution of Total Cell-associated HIV-DNA
Change from baseline to week 48
|
0 percentage of change
Interval -29.0 to 111.0
|
—
|
—
|
|
Evolution of Total Cell-associated HIV-DNA
Change from baseline to week 96
|
0 percentage of change
Interval -37.0 to 45.0
|
—
|
—
|
SECONDARY outcome
Timeframe: from day 0 to week 48 and week 96Outcome measures
| Measure |
Raltegravir and Etravirine
n=165 Participants
raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.
Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.
|
Premenopausal With Reduced Ovarian Reserve
AMH\<0.02 ng/ml at inclusion in non-menopausal women who were classified as pre-menopausal
|
Postmenopausal
The menopausal status was recorded by the questionnaire at inclusion
|
|---|---|---|---|
|
Evolution of CD4+, CD8+ T Cells Counts and CD4/CD8 Ratio
CD4: 0-48 week
|
1.1 percentage of change
Interval -10.9 to 16.6
|
—
|
—
|
|
Evolution of CD4+, CD8+ T Cells Counts and CD4/CD8 Ratio
CD8: 0-48 week
|
-1.8 percentage of change
Interval -18.7 to 16.6
|
—
|
—
|
|
Evolution of CD4+, CD8+ T Cells Counts and CD4/CD8 Ratio
CD4/CD8: 0-48 week
|
5.7 percentage of change
Interval -5.7 to 13.8
|
—
|
—
|
|
Evolution of CD4+, CD8+ T Cells Counts and CD4/CD8 Ratio
CD4: 0-96 week
|
5.0 percentage of change
Interval -9.4 to 18.9
|
—
|
—
|
|
Evolution of CD4+, CD8+ T Cells Counts and CD4/CD8 Ratio
CD8: 0-96 week
|
-5.2 percentage of change
Interval -17.1 to 11.2
|
—
|
—
|
|
Evolution of CD4+, CD8+ T Cells Counts and CD4/CD8 Ratio
CD4/CD8: 0-96 week
|
7.4 percentage of change
Interval -2.6 to 21.9
|
—
|
—
|
SECONDARY outcome
Timeframe: From day 0 to week 48 and week 96Population: After week 48, only 156 participants remained on the study treatment
Number of all clinical and biological adverse events effects. Number of grade 3 or 4 clinical and biological adverse events and effects.
Outcome measures
| Measure |
Raltegravir and Etravirine
n=165 Participants
raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.
Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.
|
Premenopausal With Reduced Ovarian Reserve
AMH\<0.02 ng/ml at inclusion in non-menopausal women who were classified as pre-menopausal
|
Postmenopausal
The menopausal status was recorded by the questionnaire at inclusion
|
|---|---|---|---|
|
Number of Participants Experiencing Adverse Events and Effects
Any AE: 0-48 week
|
154 Participants
|
—
|
—
|
|
Number of Participants Experiencing Adverse Events and Effects
Grade 3 or 4 AE: 0-48 week
|
15 Participants
|
—
|
—
|
|
Number of Participants Experiencing Adverse Events and Effects
Any AE : 48-96
|
108 Participants
|
—
|
—
|
|
Number of Participants Experiencing Adverse Events and Effects
Grade 3 or 4 AE: 48-96
|
11 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: from day 0 to week 96Population: the number analyzed in one or more rows differs from overall number analyzed due to the Non determined data
Outcome measures
| Measure |
Raltegravir and Etravirine
n=165 Participants
raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.
Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.
|
Premenopausal With Reduced Ovarian Reserve
AMH\<0.02 ng/ml at inclusion in non-menopausal women who were classified as pre-menopausal
|
Postmenopausal
The menopausal status was recorded by the questionnaire at inclusion
|
|---|---|---|---|
|
Evolution of Metabolic Parameters (Fasting Triglycerides, Total Cholesterol, HDL-cholesterol, LDL-cholesterol and Fasting Glycemia)
total cholesterol
|
-0.5 percentage of change
Interval -16.3 to 7.6
|
—
|
—
|
|
Evolution of Metabolic Parameters (Fasting Triglycerides, Total Cholesterol, HDL-cholesterol, LDL-cholesterol and Fasting Glycemia)
HDL-cholesterol
|
5.4 percentage of change
Interval -7.1 to 21.6
|
—
|
—
|
|
Evolution of Metabolic Parameters (Fasting Triglycerides, Total Cholesterol, HDL-cholesterol, LDL-cholesterol and Fasting Glycemia)
LDL-cholesterol
|
-4.3 percentage of change
Interval -19.2 to 10.2
|
—
|
—
|
|
Evolution of Metabolic Parameters (Fasting Triglycerides, Total Cholesterol, HDL-cholesterol, LDL-cholesterol and Fasting Glycemia)
fasting glycemia
|
0 percentage of change
Interval -7.0 to 10.0
|
—
|
—
|
|
Evolution of Metabolic Parameters (Fasting Triglycerides, Total Cholesterol, HDL-cholesterol, LDL-cholesterol and Fasting Glycemia)
fasting triglycerides
|
-18.8 percentage of change
Interval -40.2 to 10.4
|
—
|
—
|
SECONDARY outcome
Timeframe: from day 0 to week 48 and at week 96Population: the number of analyzed participants differs from overall participants due to the Non determined data.
The Framingham risk score is expressed as a percentage. Higher scores mean a worse outcome and lower scores mean better outcome. Median percent change expressed as median (interquartile range (IQR))
Outcome measures
| Measure |
Raltegravir and Etravirine
n=128 Participants
raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.
Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.
|
Premenopausal With Reduced Ovarian Reserve
AMH\<0.02 ng/ml at inclusion in non-menopausal women who were classified as pre-menopausal
|
Postmenopausal
The menopausal status was recorded by the questionnaire at inclusion
|
|---|---|---|---|
|
Evolution of the Calibrated 5-year Framingham Risk Score
from D0 to week 48
|
1.0 Median percent change as median (IQR)
Interval -22.9 to 37.7
|
—
|
—
|
|
Evolution of the Calibrated 5-year Framingham Risk Score
from D0 to week 96
|
9.7 Median percent change as median (IQR)
Interval -21.3 to 45.7
|
—
|
—
|
SECONDARY outcome
Timeframe: from day 0 to week 96Percent change of the estimated Glomerular Filtration Rate (eGFR) calculated using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration Calculator) formula
Outcome measures
| Measure |
Raltegravir and Etravirine
n=165 Participants
raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.
Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.
|
Premenopausal With Reduced Ovarian Reserve
AMH\<0.02 ng/ml at inclusion in non-menopausal women who were classified as pre-menopausal
|
Postmenopausal
The menopausal status was recorded by the questionnaire at inclusion
|
|---|---|---|---|
|
Percent Change of Renal Function
|
-0.6 Median percent change, as median (IQR)
Interval -6.6 to 4.2
|
—
|
—
|
SECONDARY outcome
Timeframe: from day 0 to week 96Population: Five participants were not evaluated at week 96
Evolution of total fat mass, limb fat and trunk fat from day 0 to week 96
Outcome measures
| Measure |
Raltegravir and Etravirine
n=75 Participants
raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.
Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.
|
Premenopausal With Reduced Ovarian Reserve
AMH\<0.02 ng/ml at inclusion in non-menopausal women who were classified as pre-menopausal
|
Postmenopausal
The menopausal status was recorded by the questionnaire at inclusion
|
|---|---|---|---|
|
Evolution of Body Fat Distribution From Day 0 to W96 (DXA Scan Sub-study, 80 Patients)
Total fat mass, Kg
|
12.2 percentage of change
Interval -1.0 to 24.2
|
—
|
—
|
|
Evolution of Body Fat Distribution From Day 0 to W96 (DXA Scan Sub-study, 80 Patients)
Limb fat, Kg
|
11.6 percentage of change
Interval 0.7 to 27.8
|
—
|
—
|
|
Evolution of Body Fat Distribution From Day 0 to W96 (DXA Scan Sub-study, 80 Patients)
Trunk fat, Kg
|
12.2 percentage of change
Interval -1.9 to 23.3
|
—
|
—
|
SECONDARY outcome
Timeframe: from day 0, to week 48 and week 96Population: The number analyzed in one or more rows differs from overall number analyzed due to the missing data
• Evolution of bone mineral density (BMD) measured by DXA scans (DXA scan sub-study, 81 patients) * Lumbar spine BMD, mg/cm2 * Total hip BMD, mg/cm2
Outcome measures
| Measure |
Raltegravir and Etravirine
n=81 Participants
raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.
Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.
|
Premenopausal With Reduced Ovarian Reserve
AMH\<0.02 ng/ml at inclusion in non-menopausal women who were classified as pre-menopausal
|
Postmenopausal
The menopausal status was recorded by the questionnaire at inclusion
|
|---|---|---|---|
|
Sub-study: Bone Mineral Density
Lumbar spine BMD from D0 to week 48
|
0.7 percentage of change
Interval -1.1 to 2.8
|
—
|
—
|
|
Sub-study: Bone Mineral Density
Lumbar spine BMD at week 96
|
-1.0 percentage of change
Interval -2.9 to 1.8
|
—
|
—
|
|
Sub-study: Bone Mineral Density
Total hip BMD from D0 to week 48
|
0.6 percentage of change
Interval -0.9 to 1.9
|
—
|
—
|
|
Sub-study: Bone Mineral Density
Total hip BMD at week 96
|
0 percentage of change
Interval -0.8 to 1.3
|
—
|
—
|
SECONDARY outcome
Timeframe: week 48• Assessment of HIV-RNA viral load in human male genital compartment (20 patients) at week 48
Outcome measures
| Measure |
Raltegravir and Etravirine
n=20 Participants
raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.
Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.
|
Premenopausal With Reduced Ovarian Reserve
AMH\<0.02 ng/ml at inclusion in non-menopausal women who were classified as pre-menopausal
|
Postmenopausal
The menopausal status was recorded by the questionnaire at inclusion
|
|---|---|---|---|
|
Percentage of Participants With Detectable Seminal HIV-RNA Viral Load at Week 48
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: from day 0 to week 96Population: The number analyzed in one or more rows differs from overall number analyzed due to the missing data
• Evolution of the inflammation markers (IL-6hs, sCD14, sCD163, D-Dimers, IP-10, IgG, CRPus and insulin) on frozen plasma aliquots
Outcome measures
| Measure |
Raltegravir and Etravirine
n=158 Participants
raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.
Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.
|
Premenopausal With Reduced Ovarian Reserve
AMH\<0.02 ng/ml at inclusion in non-menopausal women who were classified as pre-menopausal
|
Postmenopausal
The menopausal status was recorded by the questionnaire at inclusion
|
|---|---|---|---|
|
Inflammatory Parameters
IL-6
|
0.8 percentage of change
Interval -32.4 to 58.8
|
—
|
—
|
|
Inflammatory Parameters
D-Dimer
|
16.5 percentage of change
Interval -2.6 to 40.7
|
—
|
—
|
|
Inflammatory Parameters
Insulin
|
4.6 percentage of change
Interval -16.0 to 42.5
|
—
|
—
|
|
Inflammatory Parameters
IP-10
|
-8.1 percentage of change
Interval -23.9 to 16.5
|
—
|
—
|
|
Inflammatory Parameters
sCD163
|
0.7 percentage of change
Interval -21.0 to 20.5
|
—
|
—
|
|
Inflammatory Parameters
sCD14
|
-27 percentage of change
Interval -38.0 to -8.0
|
—
|
—
|
|
Inflammatory Parameters
IgG
|
0 percentage of change
Interval -6.8 to 4.8
|
—
|
—
|
|
Inflammatory Parameters
hsCRP
|
0 percentage of change
Interval -34.2 to 55.9
|
—
|
—
|
SECONDARY outcome
Timeframe: day 0 and weeks 48 and 96Outcome measures
| Measure |
Raltegravir and Etravirine
n=165 Participants
raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.
Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.
|
Premenopausal With Reduced Ovarian Reserve
AMH\<0.02 ng/ml at inclusion in non-menopausal women who were classified as pre-menopausal
|
Postmenopausal
The menopausal status was recorded by the questionnaire at inclusion
|
|---|---|---|---|
|
Percentage of Participants Reporting a Very Good or an Excellent Quality of Life at Day 0, Weeks 48 and 96
day 0
|
63 Participants
|
—
|
—
|
|
Percentage of Participants Reporting a Very Good or an Excellent Quality of Life at Day 0, Weeks 48 and 96
week 48
|
78 Participants
|
—
|
—
|
|
Percentage of Participants Reporting a Very Good or an Excellent Quality of Life at Day 0, Weeks 48 and 96
week 96
|
77 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: at week 0, week 48, and week 96Population: Among 165 analyzed participated, 155 filled the baseline self-reported adherence questionnaire, 146 at week 48 and 136 at week 96
The compliance rate was estimated as the number of pills consumed (recorded using the self-reported 90 questionnaire) divided by the number of pills theoretically consumed, classified as low (80%), medium (80%-95%) or high (95%).
Outcome measures
| Measure |
Raltegravir and Etravirine
n=165 Participants
raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.
Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.
|
Premenopausal With Reduced Ovarian Reserve
AMH\<0.02 ng/ml at inclusion in non-menopausal women who were classified as pre-menopausal
|
Postmenopausal
The menopausal status was recorded by the questionnaire at inclusion
|
|---|---|---|---|
|
Percentage of Participants Compliant With Treatment Program.
medium (80-95) at W96
|
9 Participants
|
—
|
—
|
|
Percentage of Participants Compliant With Treatment Program.
high (>95) at W96
|
115 Participants
|
—
|
—
|
|
Percentage of Participants Compliant With Treatment Program.
low (<80) at W0
|
13 Participants
|
—
|
—
|
|
Percentage of Participants Compliant With Treatment Program.
medium (80-95) at W0
|
3 Participants
|
—
|
—
|
|
Percentage of Participants Compliant With Treatment Program.
high (>95) at W0
|
139 Participants
|
—
|
—
|
|
Percentage of Participants Compliant With Treatment Program.
low (<80) at W48
|
7 Participants
|
—
|
—
|
|
Percentage of Participants Compliant With Treatment Program.
medium (80-95) at W48
|
16 Participants
|
—
|
—
|
|
Percentage of Participants Compliant With Treatment Program.
high (>95) at W48
|
123 Participants
|
—
|
—
|
|
Percentage of Participants Compliant With Treatment Program.
low (<80) at W96
|
12 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: from day 0, to week 48Population: We evaluated the AMH level in 40 women with available samples.
We measured the Anti-mullerian Hormone (AMH) level to evaluate the ovarian reserve (from D0 to W48)
Outcome measures
| Measure |
Raltegravir and Etravirine
n=40 Participants
raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.
Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.
|
Premenopausal With Reduced Ovarian Reserve
AMH\<0.02 ng/ml at inclusion in non-menopausal women who were classified as pre-menopausal
|
Postmenopausal
The menopausal status was recorded by the questionnaire at inclusion
|
|---|---|---|---|
|
Evolution of the Ovarian Reserve From D0 to W48 Measured by AMH on Frozen Aliquots
Reproductive activity: D0
|
0.172 ng/mL
Interval 0.075 to 0.29
|
—
|
—
|
|
Evolution of the Ovarian Reserve From D0 to W48 Measured by AMH on Frozen Aliquots
Pre-menopausal: D0
|
0.009 ng/mL
Interval 0.008 to 0.012
|
—
|
—
|
|
Evolution of the Ovarian Reserve From D0 to W48 Measured by AMH on Frozen Aliquots
Post-menopausal: D0
|
0.009 ng/mL
Interval 0.008 to 0.0095
|
—
|
—
|
|
Evolution of the Ovarian Reserve From D0 to W48 Measured by AMH on Frozen Aliquots
Reproductive activity: W48
|
0.152 ng/mL
Interval 0.034 to 0.4
|
—
|
—
|
|
Evolution of the Ovarian Reserve From D0 to W48 Measured by AMH on Frozen Aliquots
Pre-menopausal: W48
|
0.008 ng/mL
Interval 0.006 to 0.01
|
—
|
—
|
|
Evolution of the Ovarian Reserve From D0 to W48 Measured by AMH on Frozen Aliquots
Post-menopausal: W48
|
0.005 ng/mL
Interval 0.004 to 0.007
|
—
|
—
|
SECONDARY outcome
Timeframe: from day 0, to week 48Population: We evaluated the MCP1 level in 40 women with available samples.
Outcome measures
| Measure |
Raltegravir and Etravirine
n=40 Participants
raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.
Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.
|
Premenopausal With Reduced Ovarian Reserve
AMH\<0.02 ng/ml at inclusion in non-menopausal women who were classified as pre-menopausal
|
Postmenopausal
The menopausal status was recorded by the questionnaire at inclusion
|
|---|---|---|---|
|
Evolution of the Level of MCP1 From D0 to W48 on Frozen Samples
Premenopausal with mesurable AMH
|
3.1 Percentage change
Interval -18.9 to 15.3
|
—
|
—
|
|
Evolution of the Level of MCP1 From D0 to W48 on Frozen Samples
Premenopausal with reduced ovarian reserve
|
3.5 Percentage change
Interval -2.1 to 10.9
|
—
|
—
|
|
Evolution of the Level of MCP1 From D0 to W48 on Frozen Samples
Post-menopausal
|
-2.4 Percentage change
Interval -13.7 to 14.2
|
—
|
—
|
SECONDARY outcome
Timeframe: from day 0, to week 96Population: We evaluated the AMH level in 40 women with available samples
Metabolic markers measures are total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides. Inflammatory and innate immune activation markers measures are: IL-6hs, sCD14, sCD163, D-Dimers, IP-10, IgG, hsCRP and Insulin. Ovarian reserve measure is AMH
Outcome measures
| Measure |
Raltegravir and Etravirine
n=12 Participants
raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.
Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.
|
Premenopausal With Reduced Ovarian Reserve
n=6 Participants
AMH\<0.02 ng/ml at inclusion in non-menopausal women who were classified as pre-menopausal
|
Postmenopausal
n=22 Participants
The menopausal status was recorded by the questionnaire at inclusion
|
|---|---|---|---|
|
Sub-study in Women : Comparison of the Metabolic/Inflammatory Profile in Women According to Their Ovarian Reserve and Menopausal Status at D0 and Its Evolution up to Week 96
LDL-cholesterol
|
5.52 Percentage of change
Interval -20.13 to 27.13
|
5.62 Percentage of change
Interval -13.1 to 22.08
|
-6.58 Percentage of change
Interval -19.77 to -0.07
|
|
Sub-study in Women : Comparison of the Metabolic/Inflammatory Profile in Women According to Their Ovarian Reserve and Menopausal Status at D0 and Its Evolution up to Week 96
HDL-cholesterol
|
18.47 Percentage of change
Interval 3.9 to 27.79
|
27.74 Percentage of change
Interval 16.77 to 42.86
|
-4.84 Percentage of change
Interval -11.35 to 9.92
|
|
Sub-study in Women : Comparison of the Metabolic/Inflammatory Profile in Women According to Their Ovarian Reserve and Menopausal Status at D0 and Its Evolution up to Week 96
Triglycerides
|
5.59 Percentage of change
Interval -28.1 to 27.57
|
-38.37 Percentage of change
Interval -45.18 to -13.7
|
-0.99 Percentage of change
Interval -33.12 to 16.67
|
|
Sub-study in Women : Comparison of the Metabolic/Inflammatory Profile in Women According to Their Ovarian Reserve and Menopausal Status at D0 and Its Evolution up to Week 96
hsCRP
|
5.7 Percentage of change
Interval -36.0 to 31.5
|
31.8 Percentage of change
Interval -63.3 to 122.6
|
-31.4 Percentage of change
Interval -44.7 to 19.0
|
|
Sub-study in Women : Comparison of the Metabolic/Inflammatory Profile in Women According to Their Ovarian Reserve and Menopausal Status at D0 and Its Evolution up to Week 96
D-dimers
|
6.8 Percentage of change
Interval -18.3 to 27.2
|
34.8 Percentage of change
Interval 14.6 to 90.2
|
23.1 Percentage of change
Interval -7.9 to 46.9
|
|
Sub-study in Women : Comparison of the Metabolic/Inflammatory Profile in Women According to Their Ovarian Reserve and Menopausal Status at D0 and Its Evolution up to Week 96
IgG
|
0.7 Percentage of change
Interval -5.3 to 3.7
|
1.8 Percentage of change
Interval -9.9 to 4.2
|
-1.2 Percentage of change
Interval -7.8 to 3.4
|
|
Sub-study in Women : Comparison of the Metabolic/Inflammatory Profile in Women According to Their Ovarian Reserve and Menopausal Status at D0 and Its Evolution up to Week 96
IL-6hs
|
5.9 Percentage of change
Interval -21.6 to 62.7
|
-49.9 Percentage of change
Interval -50.5 to -20.8
|
-0.9 Percentage of change
Interval -40.7 to 38.9
|
|
Sub-study in Women : Comparison of the Metabolic/Inflammatory Profile in Women According to Their Ovarian Reserve and Menopausal Status at D0 and Its Evolution up to Week 96
IP-10
|
-18.3 Percentage of change
Interval -37.3 to -2.9
|
8.2 Percentage of change
Interval -8.2 to 33.1
|
-5.4 Percentage of change
Interval -34.9 to 31.1
|
|
Sub-study in Women : Comparison of the Metabolic/Inflammatory Profile in Women According to Their Ovarian Reserve and Menopausal Status at D0 and Its Evolution up to Week 96
Insulin
|
-29.2 Percentage of change
Interval -48.6 to -0.4
|
30.3 Percentage of change
Interval -7.9 to 50.0
|
11.4 Percentage of change
Interval -14.0 to 32.8
|
|
Sub-study in Women : Comparison of the Metabolic/Inflammatory Profile in Women According to Their Ovarian Reserve and Menopausal Status at D0 and Its Evolution up to Week 96
Total cholesterol
|
6.62 Percentage of change
Interval -7.99 to 15.88
|
6.91 Percentage of change
Interval 2.38 to 17.77
|
-11.35 Percentage of change
Interval -15.81 to 2.38
|
|
Sub-study in Women : Comparison of the Metabolic/Inflammatory Profile in Women According to Their Ovarian Reserve and Menopausal Status at D0 and Its Evolution up to Week 96
sCD14
|
-31.6 Percentage of change
Interval -39.2 to -5.4
|
-32.8 Percentage of change
Interval -43.2 to -23.4
|
-18.8 Percentage of change
Interval -36.5 to -3.6
|
|
Sub-study in Women : Comparison of the Metabolic/Inflammatory Profile in Women According to Their Ovarian Reserve and Menopausal Status at D0 and Its Evolution up to Week 96
sCD163
|
10.8 Percentage of change
Interval -9.7 to 32.3
|
15.9 Percentage of change
Interval -9.2 to 34.2
|
4.8 Percentage of change
Interval -21.0 to 49.0
|
SECONDARY outcome
Timeframe: from day 0, to week 96Population: AMH level were evaluated in 40 women with available samples
BMI, Hip circumference, Waist circumference, waist/hip ratio, Limb fat, Trunk fat, Total fat, Limb lean, Trunk lean, and Total lean
Outcome measures
| Measure |
Raltegravir and Etravirine
n=12 Participants
raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.
Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.
|
Premenopausal With Reduced Ovarian Reserve
n=6 Participants
AMH\<0.02 ng/ml at inclusion in non-menopausal women who were classified as pre-menopausal
|
Postmenopausal
n=22 Participants
The menopausal status was recorded by the questionnaire at inclusion
|
|---|---|---|---|
|
Sub-study in Women : Comparison of the Evolution Fat Distribution Measured by DXA Scan and Body Weight According to AMH Status
Body mass index (BMI)
|
-0.96 Percentage of change
Interval -5.49 to 2.59
|
5.69 Percentage of change
Interval 0.0 to 12.2
|
2.07 Percentage of change
Interval -1.1 to 5.17
|
|
Sub-study in Women : Comparison of the Evolution Fat Distribution Measured by DXA Scan and Body Weight According to AMH Status
Hip circumference
|
7.06 Percentage of change
Interval -3.64 to 11.71
|
2.80 Percentage of change
Interval -1.16 to 8.85
|
3.09 Percentage of change
Interval -0.94 to 6.19
|
|
Sub-study in Women : Comparison of the Evolution Fat Distribution Measured by DXA Scan and Body Weight According to AMH Status
Waist circumference
|
2.74 Percentage of change
Interval -4.76 to 6.54
|
4.20 Percentage of change
Interval 2.8 to 15.85
|
6.52 Percentage of change
Interval 1.11 to 8.2
|
|
Sub-study in Women : Comparison of the Evolution Fat Distribution Measured by DXA Scan and Body Weight According to AMH Status
Waist/hip ratio
|
-3.43 Percentage of change
Interval -4.63 to -1.17
|
0.02 Percentage of change
Interval -1.42 to 10.54
|
1.85 Percentage of change
Interval -1.17 to 5.29
|
|
Sub-study in Women : Comparison of the Evolution Fat Distribution Measured by DXA Scan and Body Weight According to AMH Status
Limb fat
|
-2.94 Percentage of change
Interval -5.84 to 1.94
|
6.74 Percentage of change
Interval -1.62 to 16.91
|
10.89 Percentage of change
Interval -0.03 to 28.22
|
|
Sub-study in Women : Comparison of the Evolution Fat Distribution Measured by DXA Scan and Body Weight According to AMH Status
Trunk fat
|
-6.90 Percentage of change
Interval -12.91 to -2.27
|
18.80 Percentage of change
Interval 10.32 to 25.31
|
21.27 Percentage of change
Interval 5.96 to 39.4
|
|
Sub-study in Women : Comparison of the Evolution Fat Distribution Measured by DXA Scan and Body Weight According to AMH Status
Total fat
|
-2.59 Percentage of change
Interval -8.93 to -2.13
|
16.77 Percentage of change
Interval 7.35 to 17.91
|
24.39 Percentage of change
Interval 0.61 to 31.63
|
|
Sub-study in Women : Comparison of the Evolution Fat Distribution Measured by DXA Scan and Body Weight According to AMH Status
Limb lean
|
-0.70 Percentage of change
Interval -1.89 to 0.96
|
2.13 Percentage of change
Interval -2.73 to 6.21
|
-1.44 Percentage of change
Interval -2.91 to 1.93
|
|
Sub-study in Women : Comparison of the Evolution Fat Distribution Measured by DXA Scan and Body Weight According to AMH Status
Trunk lean
|
-0.79 Percentage of change
Interval -4.6 to 2.54
|
5.53 Percentage of change
Interval 1.93 to 20.75
|
-3.24 Percentage of change
Interval -6.2 to -0.34
|
|
Sub-study in Women : Comparison of the Evolution Fat Distribution Measured by DXA Scan and Body Weight According to AMH Status
Total lean
|
-1.35 Percentage of change
Interval -1.93 to 1.14
|
5.83 Percentage of change
Interval 2.02 to 8.12
|
-3.01 Percentage of change
Interval -4.14 to 2.94
|
Adverse Events
Raltegravir and Etravirine
Serious events: 26 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Raltegravir and Etravirine
n=165 participants at risk
raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.
Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.
|
|---|---|
|
Reproductive system and breast disorders
Prostatitis
|
1.8%
3/165 • Number of events 3 • Adverse events data were collected from baseline to week 48 and 96
|
|
Nervous system disorders
Stroke
|
1.2%
2/165 • Number of events 2 • Adverse events data were collected from baseline to week 48 and 96
|
|
Investigations
Hospitalization further diagnosis
|
1.2%
2/165 • Number of events 2 • Adverse events data were collected from baseline to week 48 and 96
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.61%
1/165 • Number of events 1 • Adverse events data were collected from baseline to week 48 and 96
|
|
Nervous system disorders
Delirious
|
0.61%
1/165 • Number of events 1 • Adverse events data were collected from baseline to week 48 and 96
|
|
Hepatobiliary disorders
Hepatic cytolysis
|
0.61%
1/165 • Number of events 1 • Adverse events data were collected from baseline to week 48 and 96
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.61%
1/165 • Number of events 1 • Adverse events data were collected from baseline to week 48 and 96
|
|
General disorders
Loss of teeth
|
0.61%
1/165 • Number of events 1 • Adverse events data were collected from baseline to week 48 and 96
|
|
General disorders
Open wound of back
|
0.61%
1/165 • Number of events 1 • Adverse events data were collected from baseline to week 48 and 96
|
|
Musculoskeletal and connective tissue disorders
Osteoarthrosis
|
0.61%
1/165 • Number of events 1 • Adverse events data were collected from baseline to week 48 and 96
|
|
Surgical and medical procedures
Parotidectomy
|
0.61%
1/165 • Number of events 1 • Adverse events data were collected from baseline to week 48 and 96
|
|
Infections and infestations
Post herpetic neuralgia
|
0.61%
1/165 • Number of events 1 • Adverse events data were collected from baseline to week 48 and 96
|
|
Infections and infestations
Urinary tract infection
|
0.61%
1/165 • Number of events 1 • Adverse events data were collected from baseline to week 48 and 96
|
|
Cardiac disorders
Acute coronary syndrome
|
0.61%
1/165 • Number of events 1 • Adverse events data were collected from baseline to week 48 and 96
|
|
Infections and infestations
Anal abcess
|
0.61%
1/165 • Number of events 1 • Adverse events data were collected from baseline to week 48 and 96
|
|
Hepatobiliary disorders
AST increased
|
0.61%
1/165 • Number of events 1 • Adverse events data were collected from baseline to week 48 and 96
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
0.61%
1/165 • Number of events 1 • Adverse events data were collected from baseline to week 48 and 96
|
|
Musculoskeletal and connective tissue disorders
Lumbago
|
0.61%
1/165 • Number of events 1 • Adverse events data were collected from baseline to week 48 and 96
|
|
Cardiac disorders
Myocardial infarction
|
0.61%
1/165 • Number of events 1 • Adverse events data were collected from baseline to week 48 and 96
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pulmonary carcinomia
|
0.61%
1/165 • Number of events 1 • Adverse events data were collected from baseline to week 48 and 96
|
|
Musculoskeletal and connective tissue disorders
Sciatica
|
0.61%
1/165 • Number of events 1 • Adverse events data were collected from baseline to week 48 and 96
|
|
Surgical and medical procedures
Surgery
|
0.61%
1/165 • Number of events 1 • Adverse events data were collected from baseline to week 48 and 96
|
Other adverse events
| Measure |
Raltegravir and Etravirine
n=165 participants at risk
raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.
Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.
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|---|---|
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Nervous system disorders
Headache
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3.6%
6/165 • Number of events 7 • Adverse events data were collected from baseline to week 48 and 96
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Nervous system disorders
Asthenia
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2.4%
4/165 • Number of events 4 • Adverse events data were collected from baseline to week 48 and 96
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Nervous system disorders
Insomnia
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2.4%
4/165 • Number of events 4 • Adverse events data were collected from baseline to week 48 and 96
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Gastrointestinal disorders
Constipation
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1.8%
3/165 • Number of events 3 • Adverse events data were collected from baseline to week 48 and 96
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Gastrointestinal disorders
Diarrhea
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1.2%
2/165 • Number of events 2 • Adverse events data were collected from baseline to week 48 and 96
|
|
Nervous system disorders
Drowsiness
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1.2%
2/165 • Number of events 2 • Adverse events data were collected from baseline to week 48 and 96
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|
Gastrointestinal disorders
dysgeusia
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1.2%
2/165 • Number of events 2 • Adverse events data were collected from baseline to week 48 and 96
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place