| Primary | Percentage of Participants in Therapeutic Success | The participants will be considered in therapeutic success at Week 48 if they did not present any of the following events:
- Plasma HIV-2 RNA load over or equal to 100 copies/mL, starting from Week 24 and confirmed within the next 4 weeks,
- CD4 lymphocytes gain below 100/mm3 at Week 48 compared to the CD4 lymphocytes counts average between Week-4 and Week 0,
- Raltegravir permanent discontinuation,
- Death from any cause,
- New B or C events confirmed by an endpoint review committee
| | Posted | | Number | 95% Confidence Interval | percentage of participants | | at Week 48 | | | | ID | Title | Description |
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| OG000 | Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate | emtricitabine / tenofovir disoproxil fumarate / raltegravir .: emtricitabine : 200 mg/day and tenofovir disoproxil fumarate : 300 mg/day, included in one pill of Truvada® QD. raltegravir : 400 mg x 2/day, 400 mg in one pill of Isentress® BID. |
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| Secondary | Median Change in CD4 Lymphocytes Count at Week 12 | | | Posted | | Median | Inter-Quartile Range | cells/µL | | between Week 0 and Week 12 | | | | ID | Title | Description |
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| OG000 | Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate | emtricitabine / tenofovir disoproxil fumarate / raltegravir .: emtricitabine : 200 mg/day and tenofovir disoproxil fumarate : 300 mg/day, included in one pill of Truvada® QD. raltegravir : 400 mg x 2/day, 400 mg in one pill of Isentress® BID. |
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| Secondary | Number of Clinical and Biological Events | | | Posted | | Number | | clinical and biological events | | from Week 0 to Week 48 | | | | ID | Title | Description |
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| OG000 | Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate | emtricitabine / tenofovir disoproxil fumarate / raltegravir .: emtricitabine : 200 mg/day and tenofovir disoproxil fumarate : 300 mg/day, included in one pill of Truvada® QD. raltegravir : 400 mg x 2/day, 400 mg in one pill of Isentress® BID. |
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| Secondary | Median Change of CD4 Lymphocytes at Week 48 | | | Posted | | Median | Inter-Quartile Range | cells/µL | | between Week 0 and Week 48 | | | | ID | Title | Description |
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| OG000 | Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate | emtricitabine / tenofovir disoproxil fumarate / raltegravir .: emtricitabine : 200 mg/day and tenofovir disoproxil fumarate : 300 mg/day, included in one pill of Truvada® QD. raltegravir : 400 mg x 2/day, 400 mg in one pill of Isentress® BID. |
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| Secondary | Percentage of Patients With Plasma HIV-2 RNA < 40 Copies/mL | | | Posted | | Number | | percentage of participants | | between Week 0 and Week 48 | | | | ID | Title | Description |
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| OG000 | Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate | emtricitabine / tenofovir disoproxil fumarate / raltegravir .: emtricitabine : 200 mg/day and tenofovir disoproxil fumarate : 300 mg/day, included in one pill of Truvada® QD. raltegravir : 400 mg x 2/day, 400 mg in one pill of Isentress® BID. |
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| Secondary | Number of Participants With Clinical Progression | Clinical progression is defined as the switch:
- from category A to B, C or death.
- from category B to C or death.
| | Posted | | Count of Participants | | Participants | | from Week 0 to Week 48 | | | | ID | Title | Description |
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| OG000 | Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate | emtricitabine / tenofovir disoproxil fumarate / raltegravir .: emtricitabine : 200 mg/day and tenofovir disoproxil fumarate : 300 mg/day, included in one pill of Truvada® QD. raltegravir : 400 mg x 2/day, 400 mg in one pill of Isentress® BID. |
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| Secondary | Minimal Observed Percentage of Participants With Moderate to Good Adherence Evaluated With ANRS Self-administered Questionnaire of Adherence | | Number of participants with available questionnaire of adherence | Posted | | Number | | percentage of participants | | from Week 4 to Week 48 | | | | ID | Title | Description |
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| OG000 | Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate | emtricitabine / tenofovir disoproxil fumarate / raltegravir .: emtricitabine : 200 mg/day and tenofovir disoproxil fumarate : 300 mg/day, included in one pill of Truvada® QD. raltegravir : 400 mg x 2/day, 400 mg in one pill of Isentress® BID. |
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| Secondary | Number of Virological Failure Participants With Resistance Mutations | Virological failure is defined as plasma HIV-2 RNA load over or equal to 100 copies/mL after plasma HIV-2 RNA load below 100copies/mL, confirmed with a retest within the 4 following weeks. The number and type of mutations in the RT and integrase genes compared to week 0 is being reported. | | Posted | | Count of Participants | | Participants | | from Week 0 to Week 48 | | | | ID | Title | Description |
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| OG000 | Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate | emtricitabine / tenofovir disoproxil fumarate / raltegravir .: emtricitabine : 200 mg/day and tenofovir disoproxil fumarate : 300 mg/day, included in one pill of Truvada® QD. raltegravir : 400 mg x 2/day, 400 mg in one pill of Isentress® BID. |
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| Secondary | Number of Participants With Treatment Switch or Discontinuation | Overall (regardless of the molecule) | | Posted | | Count of Participants | | Participants | | from Week 0 to Week 48 | | | | ID | Title | Description |
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| OG000 | Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate | emtricitabine / tenofovir disoproxil fumarate / raltegravir .: emtricitabine : 200 mg/day and tenofovir disoproxil fumarate : 300 mg/day, included in one pill of Truvada® QD. raltegravir : 400 mg x 2/day, 400 mg in one pill of Isentress® BID. |
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| Secondary | Number of Participants With >6 Copies of HIV-2 DNA in Plasma at Week 48 | | Participants with available measurements | Posted | | Count of Participants | | Participants | | at Week 48 | | | | ID | Title | Description |
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| OG000 | Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate | emtricitabine / tenofovir disoproxil fumarate / raltegravir .: emtricitabine : 200 mg/day and tenofovir disoproxil fumarate : 300 mg/day, included in one pill of Truvada® QD. raltegravir : 400 mg x 2/day, 400 mg in one pill of Isentress® BID. |
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| Secondary | Minimal Median of the Lower Dimension Out of the 4 Dimensions of the Quality of Life Questionnaire | The quality of life questionnaire is the Professional Quality of Life (PROQOL) questionnaire, including 4 dimensions: Physical health and symptoms, Relationship with others, Mental and cognitive functioning and Treatment impact For each scale, a score ranging from 0 (the worst answer) to 100 (the best answer) is calculated. | Participants with available PROQOL questionnaire | Posted | | Median | Inter-Quartile Range | Score on a scale | | from Week 0 to Week 48 | | | | ID | Title | Description |
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| OG000 | Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate | emtricitabine / tenofovir disoproxil fumarate / raltegravir .: emtricitabine : 200 mg/day and tenofovir disoproxil fumarate : 300 mg/day, included in one pill of Truvada® QD. raltegravir : 400 mg x 2/day, 400 mg in one pill of Isentress® BID. |
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| Secondary | Number of Participants With >6 Copies of HIV-2 DNA in Plasma at Week 24 | | Participants with available measurement | Posted | | Count of Participants | | Participants | | Week 24 | | | | ID | Title | Description |
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| OG000 | Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate | emtricitabine / tenofovir disoproxil fumarate / raltegravir .: emtricitabine : 200 mg/day and tenofovir disoproxil fumarate : 300 mg/day, included in one pill of Truvada® QD. raltegravir : 400 mg x 2/day, 400 mg in one pill of Isentress® BID. |
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