HIV-1 Infection MedDRA version: 17.1 Level: PT Classification code 10020161 Term: HIV infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Tivicay®
Product Name: Tivicay®
Pharmaceutical Form: Tablet
INN or Proposed INN: Dolutegravir
CAS Number: 1051375-16-6
Other descriptive name: DOLUTEGRAVIR SODIUM
Concentration unit: mg mi
Sponsors
Fundació Vall Hebron Institut de Recerca
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Adult patients infected with HIV-1 - HIV-RNA 200 / mm3 - Voluntary signature of informed consent - A woman, may be eligible to enter and participate in the study if: a. no-childbearing potential, defined as post-menopausal (12 months of spontaneous amenorrhea and ? 45 years of age) or physically unable to get pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy. b. You are of a child-bearing age with a negative pregnancy test on the day of screening and on day 1 and agrees to use one of the following contraceptive methods to prevent pregnancy: - Complete abstinence from penile-vaginal intercourse from 2 weeks before administration of the IP, over the course of the study and for at least 2 weeks after discontinuation of all study drugs; - Double barrier method (male condom / spermicide, condom male / diaphragm, diaphragm / spermicide); - Any intrauterine device (IUD) with published data that show that the expected rate of failure is =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Prior virologic failure with a integrase inhibitor - AIDS defining disease in the last 48 weeks - Glomerular filtration rate 35% of direct bilirubin) and / or unstable liver disease (presence of ascites, hepatic encephalopathy, hypoalbuminemia, presence of esophageal varices or persistent jaundice) or biliary disorders known excluding Gilbert's syndrome or asymptomatic urolithiasis) - Hepatitis B positive (HBsAg +) or need of treatment HCV during the study. - Subjects with severe hepatic damage (Child Pugh Class C). - Patients unable to understand the study protocol or any other condition that in the investigator's opinion would compromise the protocol compliance. - Pregnant or nursing women - History or presence of allergy to any of the study drugs or their components.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the HIV reservoir dynamics after the change of IP / r by dolutegravir in HIV-1 infected patients that they maintain suppressed the viral load (HIV RNA <50 copies / ml) with AN ART 2 and 1 IP / r;Secondary Objective: To study the evolution of immune activation and inflammatory markers in both treatment groups;Primary end point(s): Changes in mean CD4 + T 2LTR in peripheral blood collected at weeks 1, 2, 4, 12 and 24 of the study lymphocytes compared to day 0;Timepoint(s) of evaluation of this end point: Weeks 1, 2, 4, 12 and 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Analysis by qPCR of DNA-HIV associated to CD4+ lymphocytes peripheral blood, obtained on day 0 and weeks 12 and 24 of the study and in CD4+ lymphocytes from ileum biopsies performed on day 0 and week 24 of the study. - Analysis by nested-qPCR (Alu-HIV PCR) of DNA-HIV integrated in T CD4+ lymphocytes from peripheral blood obtained on day 0 and weeks 12 and 24 of the study and CD4+ lymphocytes obtained from ileum biopsies performed on day 0 and week 24 of the study. - Analysis of residual plasma viremia by an ultrasensitive technique capable of detecting a copy of HIV RNA, at day 0 and weeks 12 and 24 of the study - Analysis by ddPCR (digital droplet-PCR) of HIV RNA expression in T CD4+ lymphocytes from peripheral blood obtained on day 0 and at weeks 1, 2, 12 and 24 of the study - Assessing the change in the percentage of T CD4 + naïve lymphocytes, memory and activated at weeks 1, 2, 12 and 24 of the study compared to day 0, in peripheral blood and lymphoid tissue samples, obtained by biopsy of ileum at the 24 week in relative to day 0 of the study - Assessing the change in inflammatory markers (sCD14, CRP, IL-6, IP-10, TRAIL) and pro-thrombotic (d-dimer) at weeks 12 and 24 of the study. - Plasma trough concentration(Ctrough) en una muestra obtenida 24 horas después de la última dosis de dolutegravir y el fármaco de comparación, IP / r, semana 1, 2, 4, 12 y 24 del estudio;Timepoint(s) of evaluation of this end point: Depending on the endpoint the timepoint will be different: Weeks 1, 2, 4, 12 and 24 | — |
Countries
Spain
Contacts
Public ContactUnitat de malalties infeccioses
Fundación Vall Hebron Institut de Recerca
Outcome results
None listed