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

Discordant Immunological Response in HIV Infected Subjects Clinical Trial

Official title:

Clinical Trial Phase I/II, of Test of Concept, Blind Double, Randomized, Controlled With Placebo, to Assess the Safety and Efficiency of the Treatment With Allogenic Adult Mesenchymal Stem Cells From Adipose Tissue Expanded, in HIV-infected Patients With Controlled Viremia and Immunological Discordant Response

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02290041
• Other study ID #: CeTMAd-VIH-2014
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: February 8, 2017
• Est. completion date: July 30, 2019

Study information

• Verified date: March 2020
• Source: Andalusian Network for Design and Translation of Advanced Therapies
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: July 30, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Discordant Immunological Response in HIV Infected Subjects
• Viremia

Intervention

Drug:
• Infusion of MSC
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 placebo
Infusion of placebo (weeks 0-4-8-20)

Locations

Country	Name	City	State
Spain	Virgen del Rocío University Hospital	Seville

Sponsors (2)

Lead Sponsor	Collaborator
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud	Iniciativa Andaluza en Terapias Avanzadas

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse reactions	Incidence of adverse reactions grade 3 and 4 according to DAIDs scale	24 months
Primary	Incidence of opportunist diseases		24 months
Primary	Changes in CD4+ cell count and CD4+/CD8+ ratio	Changes in CD4+ cell count and CD4+/CD8+ ratio as measured by flow citometry	28 days after the 4th infusion MSCs/placebo
Secondary	T CD4 +/µl count evolution and CD4 +/CD8 + ratio throughout 48 weeks		48 weeks