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HIV-1 InfectionPhase 2NCT02527096

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 Phase 2 study testing dolutegravir (Tivicay®) - Phase 1, lamivudine (Epivir®) - Phase 2 and dolutegravir (Tivicay®) - Phase 2 in people with HIV-1 Infection, run by ANRS, Emerging Infectious Diseases at 18 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV-1 Infection
What is being tested?
dolutegravir (Tivicay®) - Phase 1, lamivudine (Epivir®) - Phase 2 and dolutegravir (Tivicay®) - Phase 2
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
18 sitesFrance
Study dates
17 Sep 2015to Mar 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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),
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  • 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)

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

France18 sites

  • Hôpital Avicenne

    Bobigny, 93009

  • Hôpital Saint-André

    Bordeaux, 33000

  • Hôpital Gabriel Montpied

    Clermont-Ferrand, 63003

  • Hôpital du Bocage

    Dijon, 21079

  • Hôpital Pierre Zobda-Quitman

    Fort de France, 97261

  • Hôpial Bicêtre

    Le Kremelin Bicêtre, 94270

  • Hôpital Gui de Chaudiac

    Montpellier, 34295

  • Hôpital de l'Hotel Dieu

    Nantes, 44093

  • Hôpital Saint-Louis

    Paris, 75010

  • Hôpital Saint-Antoine

    Paris, 75012

  • Hôpital Pitié-Salpêtrière

    Paris, 75013

  • Hôpital Necker

    Paris, 75015

  • Hôpital Bichat

    Paris, 75018

  • Centre hospitalier de Pernignan

    Perpignan, 66046

  • Hôpital Pontchaillou

    Rennes, 35033

  • Hôpital Purpan

    Toulouse, 31059

  • Hôpital Gustave Dron

    Tourcoing, 59208

  • Hôpital Bretonneau

    Tours, 37044

Other trials in France

About this study

Official title: 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

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.

Read the 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
Being tested
dolutegravir (Tivicay®) - Phase 1, lamivudine (Epivir®) - Phase 2, dolutegravir (Tivicay®) - Phase 2
Keywords
dolutegravir(Tivicay®), lamivudine(Epivir®), HIV-1, efficacy, safety

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dolutegravir (Tivicay®) - Phase 1Drug

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

  • lamivudine (Epivir®) - Phase 2Drug

    • 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 2Drug

    • 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.
Study groups in NCT02527096
Study groupRoleWhat they receive
dolutegravir(Tivicay®) and lamivudine(Epivir®)ExperimentalNot described
Receives: Drug: dolutegravir (Tivicay®) - Phase 1; Drug: lamivudine (Epivir®) - Phase 2; Drug: dolutegravir (Tivicay®) - Phase 2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Virological success without any intercurrent event leading to interrupt the strategy of the trial (analysis)

    Virological failure is defined by plasma HIV RNA > 50 cp/mL on 2 following samples at 2 to 4 weeks apart.

    Measured: from week 8 to week 56 (± 4 weeks)

Secondary outcomes (10)

  1. Evolution of CD4 and CD8 lymphocytes count (analysis)

    Evaluation was calculated as the CD4 count at the corresponding week minus the baseline CD4 count

    Measured: from week 8 to week 32 and week 56

  2. Percentage of participants who discontinued the strategy of the trial for toxicity or with adverse event of grade 3 or 4 (analysis)

    Measured: week 56

  3. Profile of resistance mutations in plasma in case of virological failure

    Measured: week 56

  4. Percentage of participants with plasma HIV RNA < 1 cp/mL

    Measured: Day 0, week 8, week 32 and week 56

  5. Influence of total DNA on the occurrence of virological failure or blip

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

    Measured: from Day 0 to week 56

  6. Measure of concentrations of dolutegravir(Tivicay®) and lamivudine(Epivir®) in case of virological failure or with a blip

    Measured: week 56

  7. Measure of adherence to treatment (self-reported)

    Measured: Day 0, week 4, week 8, week 32 and week 56

  8. Measure of quality of life (self-reported)

    Measured: Day 0, week 8 and week 56

  9. Comparison of Medico-economic substudy (analysis)

    Evaluation of medico-economic aspects. Evaluate the direct medical cost related to dolutegravir and lamivudine versus the cost of the previous treatment.

    Measured: week 56

  10. Sperm substudy measure of concentration

    Measure of concentrations of dolutegravir and NRTI, and HIV RNA in semen at Week 8 and Week 32 in a subgroup of 20 participants

    Measured: Week 8 and week 32

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2015 (estimated)
  2. Study start17 Sep 2015
  3. Primary completionMar 2017
  4. Study completionMar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02527096
Sponsor's protocol ID
ANRS 167 Lamidol
Other IDs
2015-001492-44, 2015
Status last verified
Aug 2017
First submitted
6 Aug 2015
Last updated
22 Aug 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing dolutegravir (Tivicay®) - Phase 1, lamivudine (Epivir®) - Phase 2 and dolutegravir (Tivicay®) - Phase 2 in people with HIV-1 Infection, run by ANRS, Emerging Infectious Diseases at 18 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Virological success without any intercurrent event leading to interrupt the strategy of the trial (analysis) (time frame: from week 8 to week 56 (± 4 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02527096.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2017; AzTrials last refreshed its copy on 7 Nov 2026.

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