Treatment With MSC in HIV-infected Patients With Controlled Viremia and Immunological Discordant Response

Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud5 enrolled

Overview

Phase I/IIClinical trial, proof of concept, double blind, and placebo-controlled, randomized 2:1 (MSCs: placebo), total sample size is 15 subjects

This is a phase I-II, randomised, placebo-controlled, clinical trial, currently ongoing in a single Spanish hospital (Hospital Virgen del Rocío, Seville), to evaluate the safety and feasibility of a 4-doses treatment regimen with MSCs (1 million cells/Kg MSCs, weeks 0-4-8-20) in HIV infected adults with swith discordant virological and immunological response to antiretroviral therapy. In the initial phase of the trial (n=5), patients were sequentially recruited, with a safety period of 15 days, receiving unblinded cell therapy. In the second phase of the trial, subjects are block randomised (1:1) to receive either MSCs (n=5), or placebo (n=5), as the control treatment. Immune response variables, adverse events, opportunistic infection signs are evaluated as determinants of safety and efficacy of MSCs. Study endpoints are measured along a follow-up period of 24 months, that includes 17 visits according to a decreasing frequency rate. Intention to treat, and per protocol, and safety analysis will be performed.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Discordant Immunological Response in HIV Infected Subjects

Interventions

Infusion of MSCDRUG

Intravenous infusion of 4 doses of adipose tissue derived allogeneic adult mesenchymal stem cells (1 million MSCs/Kg, weeks 0-4-8-20).

Infusion of placeboDRUG

Infusion of placebo (weeks 0-4-8-20)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Confirmed HIV infection * Age\> 18 years, both sexes * In treatment with antiretroviral therapy (ART) * Sustained HIV viral load \<50 copies / ml for ≥ 1 years prior to study entry * CD4 + cell count \< 350/mL * Immunological discordant response defined as: an increase \<75 or \<150 in CD4+ cell counts within one or two years of undetectable viraemia, respectively; or CD4 + cell count \<350/mcl after 3 years of ART and undetectable viraemia (\<50 copies/ml) ≥ 1 year * Writen informed consent * In women of child bearing potential or her partners:commitment to use contraceptive method of proved efficiency throughout the duration of the clinical trial Exclusion Criteria: * Pregnancy, breastfeeding, or refusal to the use of contraceptive methods * Opportunistic infections in the last 12 months prior to study entry * Active co-infection with hepatitis B virus/hepatitis C virus * Child Pugh's scale stage C cirrhosis of the liver of any a aetiology * Portal hypertension and / or hypersplenism of any aetiology * Malignant neoplasia * Treatment with steroids, immunomodulators, interferon, chemotherapy or any other medicinal product that could modify the number of CD4+ within the last 12 months prior to study entry * Confirmed analytical 3 or 4 grade (AIDS Clinical Trials Group scale) abnormalities

Locations (1)

Virgen del Rocío University Hospital

Seville, Spain

Outcomes

Primary Outcomes

Incidence of adverse reactions

Incidence of adverse reactions grade 3 and 4 according to DAIDs scale

Time frame: 24 months

Incidence of opportunist diseases

Time frame: 24 months

Changes in CD4+ cell count and CD4+/CD8+ ratio

Changes in CD4+ cell count and CD4+/CD8+ ratio as measured by flow citometry

Time frame: 28 days after the 4th infusion MSCs/placebo

Secondary Outcomes

T CD4 +/µl count evolution and CD4 +/CD8 + ratio throughout 48 weeks

Time frame: 48 weeks

Data from ClinicalTrials.gov

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