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Clinical Trial Summary

The principal objective is to evaluate the antiviral efficacy of 48 weeks treatment with the two-drugs combination dolutegravir(Tivicay®) and lamivudine(TEpivir®) in HIV-1 infected patients virologically suppressed with triple HAART.


Clinical Trial Description

Secondary objectives:

The following parameters will be evaluated :

- Evolution of CD4 cells and CD8 cells

- Tolerance to treatment

- Emergence of resistance mutations at time of virological failure

- HIV viral load measured with ultrasensitive assay (threshold 1 copy/mL) at Day 0, Week 8, Week 32 and Week 56

- Influence of total DNA at Day 0 on the occurrence of virological failure or blip

- Plasma levels of dolutegravir(Tivicay®) and lamivudine in participants with virological failure

- Adherence to treatment

- Quality of life

- Medico-economic aspects

- Dolutegravir(Tivicay®) and Nucleosidic Reverse Transcriptase Inhibitors (NRTIs) levels, and HIV viral load in semen in a subgroup of 20 participants.

Methodology:

Pilot trial, multicentric, national, prospective, no randomized and no comparative. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02527096
Study type Interventional
Source French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Contact
Status Completed
Phase Phase 2
Start date September 17, 2015
Completion date March 2017

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