HIV-1 infected patients MedDRA version: 14.1 Level: PT Classification code 10020161 Term: HIV infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: PEGASYS*SC 1FL 180MCG/1ML
Pharmaceutical Form: Solution for injection
INN or Proposed INN: NA
CAS Number: NA
Current Sponsor code: IFNHIV
Other descriptive name: NA
Concentration unit: µg/
Sponsors
ISTITUTO NAZIONALE DELLE MALATTIE INFETTIVE LAZZARO SPALLANZANI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Will be enrolled only patients who require interruption of HAART for toxicity or who spontaneously decide to suspend the anti-HIV therapy. • Patients male and female with age between 18 and 65 years. • Aware of providing informed consent • Patients with HIV infection with ELISA and Western Blot documented, with a stable viral load suppressed by at least 18 months in the course of antiretroviral treatment effective. • HIV RNA 500 cells / mL (nadir = 250 cells / mL) conscription • HIV RNA> 10,000 copies / mL before the antiretroviral treatment • For female patients negative pregnancy test (Beta HCG) and use of effective contraception during the study • Karnofsky score = 80% • Adherence to treatment regimen and the planned study • Abstention from the use of immunomodulatory drugs during the study • Thyroid function in the norm Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Pregnancy in place and / or breastfeeding • CD4 + cell counts x2), drug addiction, alcohol abuse, uncontrolled diabetes mellitus • History of heart disease • History of depression and / or severe psychiatric disorders • Chronic hepatitis HBV co • History of autoimmune disorders including: Crohn's disease, ulcerative colitis the rectum, psoriasis, rheumatoid arthritis, myositis • History of trapaianto • Hypersensitivity to interferon
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effectiveness of 'pegylated interferon alfa-2a (180 µg) once a week as a simplification of HAART, to keep the HIV viral load suppressed when started 1 week before the suspension of HAART in patients with stably suppressed viremia (HIV RNA <40 copies / mL);Secondary Objective: - evaluation of toxicity and tollerability of peg-IFN alpha-2a - evaluate if peg-IFN alpha-2a is able to decrease CD4+ latently infected cells - to evaluate the effect of peg-IFN alpha-2a on the innate and specific immunitary response;Primary end point(s): The primary endpoint is the percentage of patients with viral load <400 copies / mL at the end of 12 weeks of discontinuation of HAART;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Adverse events and side effects • Phenotype of maturation and differentiation phenotype of CD4, CD8, NK, pDC, MDC, Treg and gamma / delta flow cytometry • Analysis of specific CD8 immune response against HIV antigens • NKR phenotype and cytotoxic activity against NK target cells for in vitro flow cytometry • Activities of the PCA MDC to recall antigen and HIV antigens by flow cytometry and ELISPOT • loads of HIV proviral DNA in PBMC and plasma HIV RNA zero time, 2 weeks, 4 weeks, 8 weeks and 12 weeks;Timepoint(s) of evaluation of this end point: - 12 weeks - Loads of HIV proviral DNA in PBMC and plasma HIV RNA at time zero, 2 weeks, 4 weeks, 8 weeks and 12 weeks | — |
Countries
Italy
Contacts
Public ContactDIpartimento Clinico
INMI Lazzaro Spallanzani
Outcome results
None listed