NCT02527096 - A Trial Evaluating Maintenance Therapy With Lamivudine (Epivir®) and Dolutegravir (Tivicay®) in Human Immunodeficiency Virus 1 (HIV-1) Infected Patients Virologically Suppressed With Triple Highly Active Antiretroviral Therapy (HAART) (ANRS 167 Lamidol) | Biotech Hunter

Enrollment

110

Participants

Timeline

Start Date

September 17, 2015

Primary Completion Date

March 31, 2017

Study Completion Date

March 31, 2017

Conditions

HIV-1 Infection

Interventions

DRUG

dolutegravir (Tivicay®) - Phase 1

• Phase 1 (8 weeks) : switch of the third agent with dolutegravir(Tivicay®) 50 mg once a day.

DRUG

lamivudine (Epivir®) - Phase 2

• Phase 2 (48 weeks): combination with lamivudine (Epivir®) 300 mg once a day + dolutegravir (Tivicay®) 50 mg once a day. Only participants with plasma HIV RNA ≤ 50 cp/mL at Week 8 will continue on phase 2.

DRUG

dolutegravir (Tivicay®) - Phase 2

Trial Locations (18)

21079

Hôpital du Bocage, Dijon

31059

Hôpital Purpan, Toulouse

33000

Hôpital Saint-André, Bordeaux

34295

Hôpital Gui de Chaudiac, Montpellier

35033

Hôpital Pontchaillou, Rennes

37044

Hôpital Bretonneau, Tours

44093

Hôpital de l'Hotel Dieu, Nantes

59208

Hôpital Gustave Dron, Tourcoing

63003

Hôpital Gabriel Montpied, Clermont-Ferrand

66046

Centre hospitalier de Pernignan, Perpignan

75010

Hôpital Saint-Louis, Paris

75012

Hôpital Saint-Antoine, Paris

75013

Hôpital Pitié-Salpêtrière, Paris

75015

Hôpital Necker, Paris

75018

Hôpital Bichat, Paris

93009

Hôpital Avicenne, Bobigny

94270

Hôpial Bicêtre, Le Kremelin Bicêtre

97261

Hôpital Pierre Zobda-Quitman, Fort de France