| Primary | Percentage of Participants With Successful Virological Suppression at Weeks 48 and 96 | 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 | | Posted | | Number | 95% Confidence Interval | percentage of participant | | at week48 and at week 96 | | | | ID | Title | Description |
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| OG000 | 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. |
| | | Title | Denominators | Categories |
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| at week 48 | | | | at week 96 | | |
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| Secondary | Percentage of Patients With Therapeutic Success at Week 48 and Week 96 | Therapeutic 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 | | Posted | | Number | 95% Confidence Interval | percentage of participants | | weeks 48 and 96 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Percentage of Patients With Trial Treatment Interruption at Week 48 and Week 96 | | | Posted | | Number | 95% Confidence Interval | percentage of participant | | weeks 48 and 96 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Percentage of Patients With With Grade Virological Failure (HIV-RNA Plasma VL Between 51 and 200 Copies/mL) | | | Posted | | Number | 95% Confidence Interval | percentage of participants | | weeks 48 and 96 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Median Time of Virological Failure | Time between the date of the study treatment initiation and the date of virological failure | | Posted | | Median | Full Range | weeks | | week 96 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Percentage of Patients With High Grade of Virological Failure Defined as HIV RNA > 200 Copies/mL | | | Posted | | Mean | 95% Confidence Interval | percentage of participants | | weeks 48 and 96 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Number of Patients With RAL and/or ETR Resistance Mutations Among Those With Virological Failure | | | Posted | | Number | | participants | | week 96 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Factors Associated With the Occurrence of Plasma HIV-RNA Viral Load > 50 Copies/mL | | | Posted | | Number | 95% Confidence Interval | hazard ratio | | week 96 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Evolution of Total Cell-associated HIV-DNA | | | Posted | | Median | Inter-Quartile Range | percentage of change | | from day 0 to week 48 and week 96 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Evolution of CD4+, CD8+ T Cells Counts and CD4/CD8 Ratio | | | Posted | | Median | Inter-Quartile Range | percentage of change | | from day 0 to week 48 and week 96 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Number of Participants Experiencing Adverse Events and Effects | Number of all clinical and biological adverse events effects. Number of grade 3 or 4 clinical and biological adverse events and effects. | After week 48, only 156 participants remained on the study treatment | Posted | | Count of Participants | | Participants | | From day 0 to week 48 and week 96 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Evolution of Metabolic Parameters (Fasting Triglycerides, Total Cholesterol, HDL-cholesterol, LDL-cholesterol and Fasting Glycemia) | | the number analyzed in one or more rows differs from overall number analyzed due to the Non determined data | Posted | | Median | Inter-Quartile Range | percentage of change | | from day 0 to week 96 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Evolution of the Calibrated 5-year Framingham Risk Score | 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)) | the number of analyzed participants differs from overall participants due to the Non determined data. | Posted | | Median | Inter-Quartile Range | Median percent change as median (IQR) | | from day 0 to week 48 and at week 96 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Percent Change of Renal Function | Percent change of the estimated Glomerular Filtration Rate (eGFR) calculated using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration Calculator) formula | | Posted | | Median | Inter-Quartile Range | Median percent change, as median (IQR) | | from day 0 to week 96 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Evolution of Body Fat Distribution From Day 0 to W96 (DXA Scan Sub-study, 80 Patients) | Evolution of total fat mass, limb fat and trunk fat from day 0 to week 96 | Five participants were not evaluated at week 96 | Posted | | Median | Inter-Quartile Range | percentage of change | | from day 0 to week 96 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Sub-study: Bone Mineral Density | • 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
| The number analyzed in one or more rows differs from overall number analyzed due to the missing data | Posted | | Median | Inter-Quartile Range | percentage of change | | from day 0, to week 48 and week 96 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Percentage of Participants With Detectable Seminal HIV-RNA Viral Load at Week 48 | • Assessment of HIV-RNA viral load in human male genital compartment (20 patients) at week 48 | | Posted | | Count of Participants | | Participants | | week 48 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Inflammatory Parameters | • Evolution of the inflammation markers (IL-6hs, sCD14, sCD163, D-Dimers, IP-10, IgG, CRPus and insulin) on frozen plasma aliquots | The number analyzed in one or more rows differs from overall number analyzed due to the missing data | Posted | | Median | Inter-Quartile Range | percentage of change | | from day 0 to week 96 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Percentage of Participants Reporting a Very Good or an Excellent Quality of Life at Day 0, Weeks 48 and 96 | | | Posted | | Count of Participants | | Participants | | day 0 and weeks 48 and 96 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Percentage of Participants Compliant With Treatment Program. | 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%). | Among 165 analyzed participated, 155 filled the baseline self-reported adherence questionnaire, 146 at week 48 and 136 at week 96 | Posted | | Count of Participants | | Participants | | at week 0, week 48, and week 96 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Evolution of the Ovarian Reserve From D0 to W48 Measured by AMH on Frozen Aliquots | We measured the Anti-mullerian Hormone (AMH) level to evaluate the ovarian reserve (from D0 to W48) | We evaluated the AMH level in 40 women with available samples. | Posted | | Median | Inter-Quartile Range | ng/mL | | from day 0, to week 48 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Evolution of the Level of MCP1 From D0 to W48 on Frozen Samples | | We evaluated the MCP1 level in 40 women with available samples. | Posted | | Median | Inter-Quartile Range | Percentage change | | from day 0, to week 48 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | 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 | 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 | We evaluated the AMH level in 40 women with available samples | Posted | | Median | Inter-Quartile Range | Percentage of change | | from day 0, to week 96 | | | | ID | Title | Description |
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| OG000 | Premenopausal With Mesurable AMH | AMH was detectable (level >0.06 ng/ml) indicating that they had an ovarian reserve and a status of reproductive activity | | OG001 | Premenopausal With Reduced Ovarian Reserve | AMH<0.02 ng/ml at inclusion in non-menopausal women who were classified as pre-menopausal | | OG002 | Postmenopausal | The menopausal status was recorded by the questionnaire at inclusion |
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| Secondary | Sub-study in Women : Comparison of the Evolution Fat Distribution Measured by DXA Scan and Body Weight According to AMH Status | BMI, Hip circumference, Waist circumference, waist/hip ratio, Limb fat, Trunk fat, Total fat, Limb lean, Trunk lean, and Total lean | AMH level were evaluated in 40 women with available samples | Posted | | Median | Inter-Quartile Range | Percentage of change | | from day 0, to week 96 | | | | ID | Title | Description |
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| OG000 | Premenopausal With Mesurable AMH | AMH was detectable (level >0.06 ng/ml) indicating that they had an ovarian reserve and a status of reproductive activity | | OG001 | Premenopausal With Reduced Ovarian Reserve | AMH<0.02 ng/ml at inclusion in non-menopausal women who were classified as pre-menopausal | | OG002 | Postmenopausal | The menopausal status was recorded by the questionnaire at inclusion |
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