Last updated 16 days ago

Study of Oral TLR8 Agonist Selgantolimod on HBsAg in Participants With Both Chronic Hepatitis B and HIV

48 patients around the world

Available in United States, Brazil, Peru

A5394 is a phase II, double-blinded, placebo-controlled trial. Forty-eight study participants will be randomized 3:1 to receive SLGN or its placebo (36 active and 12 placebo), and randomization will be stratified by HBeAg status. One-half of the study participants will be HBeAg positive (n=24) at screening, and the other half will be HBeAg negative (n=24). All participants will remain on their non-study-provided antiviral therapy throughout the study.

National Institute of Allergy and Infectious Diseases (NIAID)

3Research sites

48Patients around the world

This study is for people with

Hiv

Hepatitis

Hepatitis b

Requirements for the patient

To 70 Years

All Gender

Medical requirements

: HIV-1 infection
Effective antiviral therapy for HIV (ART) and HBV that includes TDF, TAF, TDF/FTC, TDF/3TC (tenofovir disoproxil fumarate plus lamivudine), TAF/FTC, or entecavir (ETV), for ≥5 years immediately prior to study entry. ART is defined as including a minimum of two anti-HIV antivirals.
CD4+ cell count ≥350 cells/mm3
HIV-1 RNA <50 copies/mL measured on at least two occasions at least 12 weeks apart, with no documented value >200 copies/mL, over the 12 months prior to study entry.
Positive or negative HBeAg
Negative anti-HDV
Current CHB infection
HBV DNA level <50 IU/mL measured on at least two occasions at least 12 weeks apart, with no documented value ≥50 IU/mL, over the 12 months prior to study entry.
Quantitative HBsAg >1000 IU/mL
Hepatitis C virus (HCV) antibody negative, or if the participant is HCV antibody positive, an undetectable HCV RNA.
Participants age ≥18 years and ≤70 years at study entry
Participants must agree to stay on an effective antiviral therapy for HIV (ART) and HBV throughout the study.

: Receipt of treatment for HCV within 24 weeks prior to study entry
Evidence of advanced fibrosis or cirrhosis (Metavir ≥F3 or equivalent).
Current or prior history of clinical hepatic decompensation (e.g., ascites, encephalopathy, or variceal hemorrhage)
History of HCC or cholangiocarcinoma
Malignancy within 5 years prior to study entry. NOTE: A history of non-melanoma skin cancer (e.g., basal cell carcinoma or squamous cell skin cancer) is not exclusionary.
History of solid organ transplantation
Presence of any active or acute AIDS-defining opportunistic infections within 60 days prior to study entry
History of uveitis or posterior synechiae
Breastfeeding

Sites

Hospital Nossa Senhora da Conceição

Av. Francisco Trein, 596 – 2º andar - Bairro: Cristo Redentor - CEP 91350-200 - Porto Alegre

Instituto Nacional de Infectologia Evandro Chagas

Av. Brasil, 4365 - Manguinhos, Rio de Janeiro - RJ, 21040-360

Asociación Civil Impacta Salud y Educación - Barranco Clinical Research Site

Av. Almirante Miguel Grau 1010, Barranco, Lima 04

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Study typeInterventional

Conditions

HivHepatitis b

Requirements

To 70 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT05551273