A Phase 3 interventional study of Isentress® and Celsentri® in HIV Infections, sponsored by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-12.
Sponsored by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer · Phase 3, Interventional, and Treatment
To determine the efficacy of adding Isentress®, with or without Celsentri®, to effective conventional antiretroviral therapy (comprising at least 2 reverse transcriptase inhibitors and one boosted protease inhibitor), on residual HIV replication and blood cell and gut-associated lymphoid tissue reservoirs (reverse transcriptase inhibitors: RTIs, boosted protease inhibitors: PI/r).
To evaluate the effect of therapy intensification by means of an integrase inhibitor with or without CCR5 inhibitor treatment on the lymphoid reservoir in patients chronically infected with HIV-1, successfully treated with "conventional triple therapy", measured by:
4,257 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 17 is below the median of 83 across 3,250 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer is the lead sponsor of 77 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Isentress® · Drug: Celsentri®
P.O, 1 tablet containing 400 mg every 12 hours
p.o.: 1 tablet containing 150 mg morning and evening (due to combination with PI/r) or containing 300 mg if fosamprenavir/r is used as the PI (MA)
residual plasma replication between 0 and 50 copies/ml
Time frame: one year
intracellular HIV RNA levels in circulating lymphocytes (PBMC) and lymphocytes in gut-associated rectal lymphoid tissue (RL
Time frame: one year
proviral HIV DNA levels in PBMC and RL
Time frame: one year
CD4 counts
Time frame: one year
CD8 activation levels
Time frame: one year
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer