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

Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud

Status and phase

Completed

Phase 2

Phase 1

Conditions

Discordant Immunological Response in HIV Infected Subjects

Treatments

Drug: Infusion of MSC

Drug: Infusion of placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02290041

CeTMAd-VIH-2014

Details and patient eligibility

About

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

Full description

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.

Enrollment

5 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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