Status:
COMPLETED
Treatment With MSC in HIV-infected Patients With Controlled Viremia and Immunological Discordant Response
Lead Sponsor:
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
Collaborating Sponsors:
Iniciativa Andaluza en Terapias Avanzadas
Conditions:
Discordant Immunological Response in HIV Infected Subjects
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Phase I/IIClinical trial, proof of concept, double blind, and placebo-controlled, randomized 2:1 (MSCs: placebo), total sample size is 15 subjects
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 8 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2019
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT02290041
Start Date
February 8 2017
End Date
July 30 2019
Last Update
March 4 2020
Active Locations (1)
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1
Virgen del Rocío University Hospital
Seville, Spain, 41013