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)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-17

Study Completion Date

2017-03-31

Brief Summary

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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.

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Detailed Description

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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

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HIV-1 Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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dolutegravir(Tivicay®) and lamivudine(Epivir®)

Group Type EXPERIMENTAL

dolutegravir (Tivicay®) - Phase 1

Intervention Type DRUG

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

lamivudine (Epivir®) - Phase 2

Intervention Type DRUG

• 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.

dolutegravir (Tivicay®) - Phase 2

Intervention Type DRUG

• 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.

Interventions

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dolutegravir (Tivicay®) - Phase 1

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

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* HIV-1 infected patient
* Age ≥ 18 years
* CD4 cell count nadir \> 200/mm3
* Genotype on pre-HAART interpreted with the last version of the ANRS AC11 resistance group's algorithm which presents:

* no major mutation on protease among: D30N, V32I, M46I/L, I47A/V, G48V, I50L/V, 154M/L, L76V, V82A/F/T/S, I84V, N88D/S, L90M,- no mutation on RT (except the mutation A98S if the patient is not infected by the virus subtype C),
* no mutation on integrase (if the genotype is available),
* First-line treatment with suppressive triple HAART (2 NRTI + either 1 PI/r, 1 NNRTI or 1 INI). The initial treatment may have changed a maximum of two times but only once for toxicity (changes such Epivir / Ziagen to Kivexa, are not considered as a change of treatment). However, treatment has to be unchanged in the last 6 months
* Plasma HIV RNA ≤ 50 copies/mL for ≥ 2 years with at least 2 viral load determinations per year. Blips (HIV viral load between 50 and 200 copies/mL but ≤ 50 copies/mL on control sample) are allowed except in the last 6 months. The total number of blips must not exceed 3 in the last 2 years
* Negative Hepatitis Bs Antigen
* Effective contraception for women of childbearing potential
* Informed consent form signed by patient and investigator
* Patient enrolled in or a beneficiary of a Social Security programme (State Medical Aid ("Aide Médicale d'Etat" AME in France) is not a Social Security programme)

Exclusion Criteria

* HIV-2 infection
* Positive HBc Ac isolated
* Hepatitis B Virus (HBV) co-infected patients (positive Hepatitis Bs Ag at inclusion)
* Chronic hepatitis C currently treated or needing therapy in the next 12 months
* History of HIV-associated neurocognitive disorders
* Current pregnancy or breastfeeding
* No effective contraception for the women of childbearing
* Previous treatment with chemotherapy (except bleomycin on Kaposi disease's treatment) or immunotherapy
* Grade \> 2 abnormality for usual biological parameters (liver function tests, blood cell count)
* ALT(Alanine Aminotransferase) ≥ 5 x upper limit of normal value (ULN) or AST (Aspartate Aminotransferase) ≥ 3 x ULN and bilirubinemia ≥ 1.5 x ULN (with 35% direct bilirubinemia)
* Unstable liver disease (ascitis, encephalopathy, coagulopathy, hypoalbuminemia, oesophageal or gastric varices or persistent jaundice)
* Known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
* Creatininemia clearance below 50 mL/min (Cockroft-Gault method)
* History or presence of allergy to the trial drugs or their components
* Severe hepatic insufficiency (Child Pugh Class C)
* Patients participating in another clinical trial including an exclusion period that is still in force during the screening phase
* Patients under "sauvegarde de justice" (judicial protection due to temporarily and slightly diminished mental or physical faculties) or under legal guardianship.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No