Clinical Trials Logo

Clinical Trial Summary

HIV cannot be eliminated and remains in the body despite the treatment that is used for HIV-infection called antiretroviral treatment (ART). Individuals undergoing ART interruption rapidly experience virus rebound in the blood. The current alternative therapeutic strategies to antiretroviral treatment have the aim to achieve the elimination of the virus in blood in the absence of ART. New drugs associated to ART that allow the elimination of the virus in the blood after ART withdrawn are needed. In monkeys infected with SIV, the analog of HIV, the virus has disappeared from the blood after administration of a compound and cessation of ART. There is an equivalent compound in humans called Vedolizumab. The aim of the present study is to research if Vedolizumab combined with ART, in subjects without previous ART, is able to eliminate the virus from the blood after ART is not taken.

Clinical Trial Description

HIV cannot be eradicated and keep latent in anatomical and cellular reservoirs. In fact, patients undergoing antiretroviral treatment (ART) interruption rapidly experience plasma viral load rebound. The current alternative therapeutic strategies to antiretroviral treatment have the aim to achieve the eradication or permanent remission of plasma viral load, also known as functional cure, in the absence of ART, as occurs in persistent HIV controllers. In this scenario, new drugs associated to ART that allow the achievement of permanent plasma viral remission after ART withdrawn are needed.

The main targets of HIV infection are the memory CD4+ T-cells. This cell subset is mainly located in gut associated lymphoid tissue (GALT). These lymphocytes are recruited to the gut thanks to the expression of the integrin α4β7. The Env protein gp120 binds to α4β7 and enable the dissemination of HIV in the gut. At the same time the envelope of HIV is enriched in α4β7 coming from the plasma membrane of the host cells favoring its pathogenicity. Recently, the administration of a monoclonal antibody against α4β7 was shown to achieve significant protection for HIV transmission before and after low dose intravaginal inoculation of SIV in Rhesus Macaques. Surprisingly, long-term virological protection has been documented in SIV-infected macaques after ART interruption after administration and withdrawal of the monoclonal antibody against α4β7. The mechanisms through which this antibody has achieved the permanent remission of plasma viral load are not fully understood. The success of these findings in the simian model makes the antibody against α4β7 a good candidate as ART adjuvant with the aim to reach a functional cure and/or persistent virological remission in humans. Currently, there is a monoclonal antibody against α4β7 with known safety and security profiles in humans, this antibody is commercially available under the name of Vedolizumab. This antibody is used for the treatment of ulcerative colitis and Crohn Disease. In fact, there are already two clinical trials that are using Vedolizumab in HIV-infected patients (NCT02788175 y NCT03147859). In these clinical trials Vedolizumab is administered in the chronic phase of the infection in subjects with undetectable viral load during at least two years on ART. There are not clinical trials administering Vedolizumab in early stages of infection in naïve HIV-infected subjects for ART. Potentially, this strategy of early antibody treatment may increase the success of the therapy and decrease the time on ART of the individuals. The aim of the present clinical trial is to evaluate the safety and efficacy of Vedolizumab combined with ART to achieve permanent virological remission in naïve HIV-infected individuals after ART interruption. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03577782
Study type Interventional
Source Hospitales Universitarios Virgen del Rocío
Contact Ezequiel Ruiz-Mateos, PhD
Phone +34955923109
Status Recruiting
Phase Phase 1/Phase 2
Start date September 2018
Completion date May 2020

See also
  Status Clinical Trial Phase
Recruiting NCT03067285 - A Phase IV, Open-label, Randomised, Pilot Clinical Trial Designed to Evaluate the Potential Neurotoxicity of Dolutegravir/Lamivudine/Abacavir in Neurosymptomatic HIV Patients and Its Reversibility After Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide. DREAM Study Phase 4
Completed NCT03141918 - Effect of Supplementation of Bioactive Compounds on the Energy Metabolism of People Living With HIV / AIDS N/A
Active, not recruiting NCT03256422 - Antiretroviral Treatment Taken 4 Days Per Week Versus Continuous Therapy 7/7 Days Per Week in HIV-1 Infected Patients Phase 3
Recruiting NCT03256435 - Retention in PrEP Care for African American MSM in Mississippi N/A
Completed NCT00517803 - Micronutrient Supplemented Probiotic Yogurt for HIV/AIDS and Other Immunodeficiencies N/A
Recruiting NCT03572335 - Systems Biology of Diffusion Impairment in Human Immunodeficiency Virus (HIV)
Recruiting NCT03854630 - Hepatitis B Virus Vaccination in HIV-positive Patients and Individuals at High Risk for HIV Infection Phase 4
Enrolling by invitation NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A
Completed NCT02234882 - Study on Pharmacokinetics Phase 1
Completed NCT02116660 - Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284) Phase 2
Completed NCT01968551 - Phase 3 Open-Label Study to Evaluate Switching From Optimized Stable Antiretroviral Regimens Containing Darunavir to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) Plus Darunavir (DRV) in Treatment Experienced HIV-1 Positive Adults Phase 3
Recruiting NCT03701802 - Immunogenetic Modulators of Mucosal Protection From HIV-1
Recruiting NCT03271307 - Use of HIV Self-Test Kits to Increase Identification of HIV-Infected Individuals and Their Partners N/A
Recruiting NCT03684655 - Imaging Immune Activation in HIV by PET-MR Phase 1
Active, not recruiting NCT01937455 - A Phase 1, Randomized, Blinded, Dose-escalation Study of rAAV1-PG9DP Recombinant AAV Vector Coding for PG9 Antibody in Healthy Male Adults. Phase 1
Active, not recruiting NCT01852942 - Reversing Tissue Fibrosis to Improve Immune Reconstitution in HIV Phase 2
Withdrawn NCT01975012 - Safety, Tolerability, Drug Interactions, and Antiviral Activity of Rilpivirine in Antiretroviral-Naive HIV-Infected Children Less Than 12 Years of Age Phase 1/Phase 2
Active, not recruiting NCT01931358 - Study of Boosting Strategies After Vaccination With ALVAC-HIV and AIDSVAX® B/E Phase 2
Completed NCT01923610 - Safety and Immunological Response of a Boosting Dose of MVA-B in Healthy Volunteers After 4 Years of Receiving MVA-B Phase 1
Completed NCT01439503 - Safer Sex Program for Young African-American Men Phase 2