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Study Evaluating the Safety, in Terms of HBV Virological Control At 96 Weeks, of 2 Antiviral Treatment Relief Strategies, in Patients Co-infected with the HIV-1 and HBV Viruses

ConditionsHIV InfectionsHBV Coinfection
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorANRS, Emerging Infectious Diseases

About this trial

The main objective of this study is to evaluate at 96 weeks the safety with respect to hepatitis B control of 2 treatment reduction strategies for patients with previously controlled HIV-HBV co-infection on continuous triple therapy

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

HIV-1-HBV co-infection (positive HIV-1 serology associated with 2 positive HBsAg serologies within more than 6 months);

Age ≥ 18 years

Fibroscan less than 6 months < 9kPa

Current daily antiretroviral tritherapy not modified for ≥ 12 months must including tenofovir disoproxil fumarate (TDF) 245mg or tenofovir alafenamide fumarate (TAF -25mg) associated to lamivudine (3TC - 300mg) or emtricitabine (FTC - 200mg) and a NNRTI or PI/r or INSTI to choose from

Disqualifiers

HIV-2 infection;

HIV and/or HBV genotype not compatible with dual therapy DTG-3TC or DRVr-3TC;

HBeAg+;

Fibrosis history at stage F3-F4 in pre-therapy evaluated by PBH, fibrotest and/or fibroscan with a value of Elastometry ≥ 9kPa;

Trial design

Design model

Sequential

Treatments tested in this trial

  • TDF - 245mg or TAF -25mg associated to 3TC - 300mg or FTC - 200mg and a NNRTI or PI/r or INSTI

    Drug

    The study will include patients under current daily antiretroviral tritherapy not modified for ≥ 12 months must including tenofovir disoproxil fumarate (TDF) 245mg or tenofovir alafenamide fumarate (TAF -25mg) associated to lamivudine (3TC - 300mg) or emtricitabine (FTC - 200mg) and a NNRTI or PI/r or INSTI to choose from * NNRTI = efavirenz, rilpivirine, etravirine, doravirine * PI/r = atazanavir/r ou darunavir/r * INSTI = bictegravir, dolutegravir, elvitegravir/cobicistat, raltegravir

  • Dual therapy with 3TC in combination with DTG or ritonavir-boosted Darunavir (rDVR)

    Drug

    dual therapy without TDF or TAF but including 3TC in combination with Dolutegravir (DTG) or ritonavir-boosted Darunavir (rDVR

Treatment groups

140 Participants
are divided into 3 treatment groups
Group A: Arm 1No intervention 0 interventions
Group B: Arm 2 (T4):Experimental treatment 1 intervention
Group C: Arm 3 (B7)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The proportion of participants with HBV virological failure at 96 weeks.

HBV virologoical failure is defined by 2 successive varial load ≥ 10UI/ml

Time frame
96 weeks

Secondary outcomes

1

• HBV virological success rate at 48 weeks

HBV virological success is defined by a viral load ≤10 UI/ml

Time frame
at Week 48
2

• HIV virological success rate at 48 and 96 weeks

HIV virological success is defined by a viral load ≤ 50 cp/ml

Time frame
At week 48 and week 96
3

• Time to virological failure (rebound HBV and/or HIV viral load)

Time frame
between Week 0 and Week96
4

• The rate of participants with at least one HBV viral load blip until W48 and until W96

a blip is defined by a HBV viral load \>10UI/mL followed by a control value ≤ 10UIml

Time frame
At week 48 and week 96

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ANRS, Emerging Infectious Diseases

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: