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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 | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE2

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

Interventional, Multicenter, Open-label, Randomized, Non-comparative Trial 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

NCT06338826•ANRS, Emerging Infectious Diseases

View on ClinicalTrials.gov

Summary

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. HIV-1-HBV co-infection (positive HIV-1 serology associated with 2 positive HBsAg serologies within more than 6 months);
•2. Age ≥ 18 years
•3. Fibroscan less than 6 months \< 9kPa
•4. 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;
•5. Absence of documented HBV and HIV genotypic resistance compromising virologic control of any of the maintenance strategies. Patients with no genotypic history may be included);
•6. HIV CV \< 50cp/ml for ≥ 2 years (only 1 annual blip allowed if HIV CV \< 200cp/ml and previous and subsequent viral loads are undetectable);
•7. HBV CV \< 10 IU/ml for ≥ 2 years (only 1 annual blip allowed if HBV CV \< 200IU/ml and if previous and subsequent viral loads are undetectable);
+6 more criteria

Exclusion Criteria

•1. HIV-2 infection;
•2. HIV and/or HBV genotype not compatible with dual therapy DTG-3TC or DRVr-3TC;
•3. HBeAg+;
•4. Fibrosis history at stage F3-F4 in pre-therapy evaluated by PBH, fibrotest and/or fibroscan with a value of Elastometry ≥ 9kPa;
•5. Chronic active viral hepatitis C (HCV RNA positive);
•6. Delta co-infection;
•7. Alcohol consumption \> 14 units/week for women and 21 units/week for men;
•8. Current treatment with chemo- or immunotherapy (including interferon or interleukins);
•9. Active opportunistic infection or acute treatment for opportunistic infection;
•10. Any condition (drug use, neurological, neuropsychiatric, etc.) that, in the judgment of the investigator, may compromise patient compliance and adherence to the protocol;
+2 more criteria

Key Dates

Start Date

February 1, 2025

Primary Completion Date

September 30, 2027

Completion Date

September 30, 2027

Last Updated

February 5, 2025

Enrollment

140

ESTIMATED participants

Conditions

HIV InfectionsHBV Coinfection

Interventions

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

DRUG

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

DRUG

Contacts

Fatoumata COULIBALY

CONTACT

0144236110 fatoumata.coulibaly@anrs.fr

Karine Amat

CONTACT

karine.amat@fondation-imea.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 5, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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