HIV-1 infected patients MedDRA version: 20.1 Level: LLT Classification code 10008922 Term: Chronic infection with HIV System Organ Class: 100000004862
Conditions
Interventions
Trade Name: REYATAZ - 300 MG CAPSULE RIGIDE - USO ORALE-FLACONE (POLIETILENE AD ALTA DENSITA') 30 CAPSULE
Product Name: Reyataz 300 mg
Product Code: A71IL
Pharmaceutical Form: Capsule, hard
INN or Pro
Sponsors
OSPEDALE SAN RAFFAELE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Subjects with age >18 years • Willing and able to provide informed consent • Failing a stable (at least 3 months) antiretroviral therapy (HIV-RNA > 200 copies/ml) • Any CD4 cell count • HBsAg non reactive • Virus susceptible to atazanavir, defined as a genotypic mutation score 60 ml/min using CKD-EPI equation Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Active AIDS-defining condition at Screening • Serious illness requiring systemic treatment and/or hospitalization • Current use of immunomodulant or immunosuppressive drugs • Requirement for any concomitant medications that are prohibited with any study drugs (see protocol section 3.6) • History or presence of hypersensitivity to any of the active substances or to the excipients • Alanine aminotransferase (ALT) more than 5 times the upper limit of normal (ULN), OR ALT more than 3xULN and bilirubin more than 1.5xULN (with >35% direct bilirubin) • Subjects positive for Hepatitis B at screening (HBsAg+) • Subjects with anticipated need for Hepatitis C virus (HCV) therapy during the study • Presence of moderate or severe hepatic impairment (defined as a Class B or C at Child Pugh Classification; appendix 7) or presence of unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice) or known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). • Pregnancy or pregnancy wish; breastfeeding Moreover, all clinical conditions reported as an absolute contraindication in the summary of product characteristics of the study drugs, will be considered as exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: 1. To evaluate the safety profile of DTG + ATV/r combination 2. To evaluate the 4-week efficacy of DTG+ATV/r and the time to achieve undetectability 3. To evaluate the immunological changes from baseline. 4. To evaluate the Cthrough of DTG and ATV at day 8 and at week 4, 8, 12, 16, 24 or at discontinuation 5. To detect potential risk factors related with the virological failure, including adherence and ATV and DTG concentrations 6. To describe genotypic resistance mutations for protease inhibitor and integrase inhibitors in isolates from patients with virological failure;Main Objective: To explore the 24-week efficacy of a nucleos(t)ide sparing regimen of atazanavir 300 mg QD/ ritonavir 100 mg QD + Dolutegravir 50 mg QD for the management of virologic failure in HIV-1 infected, integrase inhibitor-na¿ve subjects.;Primary end point(s): • The proportion of patients with undetectable HIV RNA viral load ( < 50 copies/ml) at week 24. ;Timepoint(s) of evaluation of this end point: week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ¿ Proportion of patients with undetectable HIV RNA viral load (< 50 copies/ml) at Week 4. ¿ Change from baseline in CD4+ cell count. ¿ Time to achieve undetectability ¿ Occurrence of genotypic resistance mutations for protease inhibitor and integrase inhibitors in isolates from patients with virological failure ¿ Atazanavir and dolutegravir Cthrough ¿ Proportion of patients with adverse events (any grade), proportion of patients with = grade 2 adverse events or abnormal laboratory tests, proportion of patients with side effects leading to discontinuation; reasons for treatment discontinuation (e.g. due to AE/Loss of viral control/Death/Patient decision). ¿ changes in lipid (total TG, total COL, HDL-col, LDL-col, total COL/HDL ratio), clearance creatinine (using CKD-EPI equation) and glycemic profile changes from baseline. ¿ Changes of ECG parameters ¿ Adherence changes since the first evaluation ;Timepoint(s) of evaluation of this end point: All the secondary endpoints will be evaluated at each timepoint of the corresponding data collection, unless otherwise specified. | — |
Countries
Italy
Contacts
Public ContactMalattie Infettive
IRCCS Ospedale San Raffaele
Outcome results
None listed