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)

A Pilot Trial Evaluating Maintenance Therapy With Lamivudine(Epivir®) and Dolutegravir(Tivicay®) in Human Immunodeficiency Virus 1 (HIV-1) Infected Patients Virologically Suppressed With Triple HAART - ANRS 167 Lamidol

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: ANRS, Emerging Infectious Diseases · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• HIV-1 Infection

Interventions

Type	Name	Description
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	• 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.

Timeline

• Start date: 2015-09-17
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2015-08-18
• Last updated: 2017-08-22

Locations

18 sites across 1 country: France