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Primary objective: Evaluation of the efficacy of TDF+3TC+EFV versus TDF+EFV QD to maintain plasma HIV-1 RNA BLQ (< 50 copies/mL) (c/mL) at 48 weeks (W48)
Main Secondary objectives:
Comparison of the two arms for genotypic resistance profile in case of virological failure
CD4 changes from baseline
Evolution of the lipid profile and morphological changes in fat distribution, and safety
Efficacy and genotypic profile data, results of lipid markers, morphological changes and main biological parameters
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | TDF+EFV |
|
| 2 | Experimental | TDF+3TC+EFV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EFV+TDF | Drug |
| ||
| EFV+3TC+TDF |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the efficacy of TDF+3TC+EFV versus TDF+EFV QD to maintain plasma HIV-1 RNA BLQ (< 50 copies/mL) (c/mL) at 48 weeks (W48) | 48 wks |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the two arms for genotypic resistance profile in case of virological failure | 48 wks | |
| CD4 changes from baseline | 48 wks | |
| Evolution of the lipid profile and morphological changes in fat distribution, and safety |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aldo Trylesinski, MD | Gilead Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| France and French West Indies | Paris | France |
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| Label | URL |
|---|---|
| Study Results | View source |
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|
| 48 wks |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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