HIV-1-infection Clinical Trial
Official title:
EHVA T02 (European HIV Vaccine Alliance Therapeutic Trial 02)/ANRS VRI07: A Phase II Randomised, Placebo-controlled Trial of Vedolizumab With or Without Therapeutic HIV MVA Vaccine in Individuals Who Started Antiretrovirals During Primary or Chronic Infection
EHVA T02 is an international, phase II, double-blind study to evaluate two experimental arms each compared to placebo control in HIV-1 positive participants to see if either has a clinically relevant impact on viral replication.
Screening will take place during the 6 weeks prior to randomisation. Eligible participants will be enrolled at week 0 and randomised to MVA HIV-B vaccine followed by vedolizumab, vedolizumab + placebo vaccine, or placebo vaccine + placebo infusions. Participants will be randomised at each centre through web-based randomisation after entering the eligibility criteria. There will be two strata: one for those who started treatment during primary infection, and one for those who started treatment during chronic infection. 69 eligible individuals from collaborating European Countries will be enrolled, aiming for approximately half who started cART in primary infection and half who started in chronic infection. Participants continue from the screening visit (up to 6 weeks before enrolment) to the last visit, a maximum of 60 weeks (around 14 months), although follow-up will continue through to the time when virus is fully suppressed. Treatment will be interrupted at week 18 and resumed when the viral load is confirmed to have rebounded to ≥100,000 copies/ml, or the CD4 falls to ≤350 cells/mm3, confirmed, or there is evidence of disease progression, or they have completed 24 weeks of treatment interruption. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03940521 -
Bioclinical Evaluation of 2 Biomarkers of Aviremic HIV-1 in CD4+ T Cells of Adults Undergoing Treatment
|
||
Completed |
NCT03227731 -
Immediate or Deferred Pre-exposure Prophylaxis for HIV Prevention: Safe Options for Pregnant and Lactating Women
|
Phase 2/Phase 3 | |
Completed |
NCT03570918 -
MGD014 in HIV-Infected Individuals on Suppressive Antiretroviral Therapy
|
Phase 1 | |
Not yet recruiting |
NCT06336434 -
CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT04022967 -
ANRS 12372 MODERATO Study
|
Phase 3 | |
Not yet recruiting |
NCT06337032 -
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
|
Phase 4 | |
Not yet recruiting |
NCT06282783 -
Studying Topiramate for Re-Activating the HIV-1 Reservoir
|
Phase 1/Phase 2 | |
Completed |
NCT04711265 -
Antibody Response to Prophylactic QHPV Vaccine at 48 Months Among HIV-infected Girls and Boys
|
||
Recruiting |
NCT03536234 -
Efficacy and Safety of GnRH Analogue Triptorelin for HIV-1 Reservoir Reduction in ART Treated HIV-1 Infected Patients
|
Phase 2 | |
Completed |
NCT04340388 -
Contribution of Dolutegravir to Obesity and Cardiovascular Disease
|
Phase 4 | |
Withdrawn |
NCT05769569 -
Safety and Efficacy of Neutralizing Antibodies and Vaccination for Induction of HIV Remission
|
Phase 1 | |
Enrolling by invitation |
NCT05584397 -
Comparing Immune Activation and Latent HIV Reservoir Size Between People Living With HIV on Tenofovir-containing Versus NRTI-free ART
|
||
Completed |
NCT04963712 -
Zadaxin and HIV-positive Patients With Immune Reconstitution Disorder
|
Early Phase 1 | |
Completed |
NCT04388904 -
Rapid Reinitiation of a Single Tablet Antiretroviral Therapy Using Symtuza® in HIV-1 Infected Treatment-Experienced Patients Off Therapy. (ReSTART)
|
Phase 4 | |
Not yet recruiting |
NCT04894357 -
Impact of V106I on Resistance to Doravirine
|
||
Completed |
NCT04568239 -
Impact of M184V on the Virological Efficacy to 3TC/DTG (LAMRES)
|
||
Not yet recruiting |
NCT04513496 -
Telemedicine in HIV Care in Buenos Aires
|
||
Not yet recruiting |
NCT04311957 -
Continuation of Protease-Inhibitor Based Second-Line Therapy vs. Switch to B/F/TAF in Virologically Suppressed Adults
|
Phase 4 | |
Not yet recruiting |
NCT04311944 -
Early Fast-Track Versus Standard Care for Persons With HIV Initiating TLD
|
N/A | |
Completed |
NCT03998176 -
Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in HIV-1 Infected Patients With Active Illicit Substance usE
|
Phase 4 |