HTLV-I Infections
Conditions
Interventions
This is a non-blinded, phase 2/3, multicenter randomized clinical trial aimed at evaluating the safety and efficacy of Dolutegravir (DTG) in preventing vertical transmission of Human T-lymphotropic Vi
Intervention group: Standard care + dolutegravir (DTG) (50 mg/day orally) initiated between 24 and 37 weeks of gestation and maintained until delivery
for the newborn, dolutegravir (DTG) 5 mg dispersible orally every 48 hours during the first two weeks and 5 mg/day dispersible orally in the subsequent weeks up to 28 days of life. Control group: Stan
Sponsors
Centro de Pesquisas Gonçalo Moniz - CPqGM/ FIOCRUZ/ BA
Ministério da Saúde (Ministério da Ciência, Tecnologia e Inovação)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Pregnant women living with Human T-lymphotropic Virus type 1 (HTLV-1), with diagnosis confirmed by Western blot, line immunoassay, or real-time polymerase chain reaction (qPCR); who agree to and consent to the participation of their newborns; and who have availability to attend the project visits.
Exclusion criteria
Exclusion criteria: Gestational age of 37 weeks or more; coinfection with Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV); presence of conditions that may compromise, in the investigator’s opinion, the safety of Dolutegravir (DTG) use and/or adherence to the protocol; participation in another clinical trial involving the use of antiretroviral agents or an experimental medication against Human T-lymphotropic Virus type 1 (HTLV-1); use of concomitant medication, including one or more agents capable of inducing the enzyme uridine diphosphate glucuronosyltransferase 1A1 (UGT1A1) and reducing Dolutegravir (DTG) concentrations, such as rifampicin, phenytoin, phenobarbital, or carbamazepine; use of concomitant medication that are substrates of the organic cation transporter 2 (OCT2), including but not limited to dofetilide, pilsicainide, or fampridine (also known as dalfampridine); individuals with known hypersensitivity to Dolutegravir (DTG) or any of its excipients. Exclusion criteria for the use of Dolutegravir (DTG) in newborns: gestational age less than 37 weeks at birth; birth weight less than 2 kilograms; known blood incompatibilities that may result in hemolytic disease of the newborn; hemoglobin value less than 13.0 g/dL; platelet count less than 50,000 cells/mm³; decreased total leukocyte count (Grade 3); creatinine value greater than 1.3 times the upper limit of normal (ULN) for gestational age and postnatal age (Grade 2); aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 2.5 times the upper limit of normal (Grade 2); any other current Grade 3 event described in the toxicity table of the Division of Acquired Immunodeficiency Syndrome (DAIDS); severe congenital abnormalities or severely ill neonates, at the discretion of the examining physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the incidence rate of infection, detected by polymerase chain reaction, in exposed children | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of clonality in children infected with Human T-cell Lymphotropic Virus type 1 (HTLV-1) (marker of viral dissemination by mitosis);To evaluate the incremental cost-effectiveness ratio, comparing the program with and without the use of integrase inhibitors;To evaluate the difference in maternal blood proviral load of Human T-cell Lymphotropic Virus type 1 (HTLV-1) at enrollment and at delivery;To evoluate the difference between maternal anti-HTLV-1 antibody titers at enrollment and at delivery;To evaluate the difference in Human T-cell Lymphotropic Virus type 1 (HTLV-1) proviral load in vaginal fluid of pregnant women at insemination and delivery;To evaluate the difference in proviral load in colostrum between pregnant women in the intervention and control groups;To evaluate the rate of occurrence of adverse events to dolutegravir (DTG) in pregnant women living with Human T-cell Lymphotropic Virus type 1 (HTLV-1) and in newborns in the intervention group;To evaluate the plasma concentration of Dolutegravir (DTG) in pregnant women and exposed newborns;To evaluate the presence of viral mutations in the pol region of Human T-cell Lymphotropic Virus type 1 (HTLV-1) before and after treatment;To evaluate the quantification of circular LTR DNA in children infected with Human T-cell Lymphotropic Virus type 1 (HTLV-1) (marker of viral dissemination by new virions) | — |
Countries
Brazil
Contacts
Public ContactMaria Fernanda Grassi
Fundação Oswaldo Cruz
Outcome results
None listed