Acute HIV Infection MedDRA version: 14.1 Level: LLT Classification code 10000811 Term: Acute infection with HIV System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Octagam
Product Name: Octagam
Pharmaceutical Form: Solution for infusion
Concentration unit: % percent
Concentration type: e
Sponsors
Guy's & St. Thomas' NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Males and females aged between 18-65 years (inclusive). 2) HIV antibody negative with p24/PCR DNA positive OR HIV antibody positive with a previous HIV negative test in the preceding 3 months OR Health Protection Agency HIV incident virus assay (estimating virus acquired within 3 months) 3) Ability and willingness to provide informed consent 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 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1) HIV negative 2) Pregnancy or lactating: at enrolment, randomisation or during study period as there is no data on IVIG in pregnant HIV+ women. 3) Patient unable or unwilling to comply with trial protocol 4) Known hypersensitivity to the active substances or to any of the excipients of the IMP 5) Current use or likely to require use of concomitant medication with known interactions with HAART regimen in accordance with SmPCs. 6) Hep B sAg positive at screening or prior to starting antiretroviral therapy (ARV) 7) Documented active Hepatitis C. 8) Previous documented pulmonary embolism (PE), deep vein thrombosis (DVT), myocardial infarction (MI) or cerebrovascular accident (CVA) 9) Women of childbearing potential unwilling to use barrier method contraception (condoms) 10) Sexually active males with female partners of childbearing potential, unwilling to use barrier method contraception (condoms) 11) Insulin dependant diabetes 12) Documented bleeding disorders (for gut sub study participants only)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate whether reactivation of HIV using immunoglobulin in individuals with AHI and virologically suppressed with ART, will reduce HIV viral reservoir at week 48.; Secondary Objective: Secondary Objectives: To investigate the effect of ART and immunoglobulin, at acute HIV infection on: a. Immune activation b. Gut permeability c. Host gene expression d. Clinical outcome e. Immunological markers of T cell exhaustion f. Inflammation Tertiary Objectives: To investigate the effect of using ART and immunoglobulin, at AHI on: a. Host adaptive immune reponses b. Low copy HIV RNA c. Inflammation ;Primary end point(s): Change in proviral DNA quantification between enrolment and week 48;Timepoint(s) of evaluation of this end point: between enrolment and W48 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Endpoints: a. Changes in CD8 T-cell activation: the percentage of CD3+ CD8+ cells expressing CD38+ b. Gut permeability: 16S DNA c. Host gene expression profiling d. Clinical outcome: CD4 T-cell counts, CD4 T cell decline, HIV RNA e. Immunological markers of T cell exhaustion: HLA-DR and PD-1 f. Inflammation (D-dimer) Tertiary Endpoints: a. Host adaptive immune responses: CD4 and CD8 HIV specific immune responses b. Low copy HIV RNA c. Inflammation (IL-6) ;Timepoint(s) of evaluation of this end point: between enrolment and W48 | — |
Countries
United Kingdom
Contacts
Public ContactJulie Fox
Guy's & St. Thomas' NHS Foundation Trust
Outcome results
None listed