EUCTR2017-003081-27-GB
Active, not recruiting
Phase 1
EHVA T01(European HIV Vaccine Alliance Therapeutic Trial 01)/ANRS VRI05: A Phase I/II randomised therapeutic HIV vaccine trial in individuals who started antiretrovirals during primary or chronic infection - EHVA T01(European HIV Vaccine Alliance Therapeutic Trial01)/ANRS VRI05
Inserm-ANRS0 sites192 target enrollmentSeptember 25, 2017
ConditionsHuman Immunodeficiency Virus (HIV) infectionMedDRA version: 20.1 Level: PT Classification code 10020161 Term: HIV infection System Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
DrugsEntyvio
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Human Immunodeficiency Virus (HIV) infection
- Sponsor
- Inserm-ANRS
- Enrollment
- 192
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. HIV\-1\-infected
- •2\. Aged 18 – 65 years old on the day of screening
- •3\. Weight \>50kg
- •4\. Written informed consent
- •5\. Nadir CD4 count \> 300 cells/mm3
- •6\. CD4 count at screening \> 600 cells/mm3
- •7\. Viral load ,\<50 copies/ml at screening.
- •8\. Started cART after 2009 and on cART for at least one year prior to screening .
- •9\. Willing to interrupt cART for up to 24weeks and change cART regimen if required.
- •10\. If sexually active, willing to use a reliable method of reducing the risk of transmission to their sexual partners during treatment interruption (which could include PrEP for their sexual partners)
Exclusion Criteria
- •1\.Pregnant or lactating
- •2\.HIV\-2 infection (either isolated or associated with HIV\-1\)
- •3\.VL \>200 copies/ml on 2 occasions in the 12 months prior to screening
- •4\.Previous interruptions in cART
- •5\.Previous virological failures defined by loss of virological suppression with the presence of resistant mutations
- •6\.Haemoglobin (Hb\<12g/dL for males, \<11g/dL for females)
- •7\.Concomitant or previous conditions that preclude injection of vaccines/infusion of monoclonal antibody and PML in the past
- •8\.History of experimental vaccinations against HIV
- •9\.Previous treatment with chemotherapy (except for chemotherapy injected into skin lesions for Kaposi’s sarcoma)
- •10\.Treatment with systemic corticoids or immuno\-suppressive agents ongoing or in the previous 12 weeks before randomisation in the trial
Outcomes
Primary Outcomes
Not specified
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