HIV-1-infectionPhase 1/2EHVAT01NCT02972450
An HIV Vaccine Trial in Individuals Who Started ART During Primary or Chronic Infection
A Phase 1/2 study testing GTU-MultiHIV B-clade vaccine + MVA HIV-B HIV vaccine, GTU-MultiHIV B-clade vaccine + MVA HIV-B HIV vaccine+ Vedolizumab and Vedolizumab 300 MG [Entyvio] in people with HIV-1-infection, run by ANRS, Emerging Infectious Diseases at 2 sites in 2 countries.
Trial summary
EVHA T01 is an international, phase I/II, multicentre, multi-stage, double-blind study that will evaluate at least three experimental arms compared to placebo control in HIV-1 infected participants to see if one or more has a clinically relevant impact on the control of viral replication. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- GTU-MultiHIV B-clade vaccine + MVA HIV-B HIV vaccine, GTU-MultiHIV B-clade vaccine + MVA HIV-B HIV vaccine+ Vedolizumab and Vedolizumab 300 MG [Entyvio]
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 20 Feb 2019to 11 Jul 2019
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-1-infected
- Aged 18 - 65 years old on the day of screening
- Weight >50kg
- Willing and able to provide written informed consent
- Nadir CD4 count > 300 cells/mm3
- CD4 count at screening > 500 cells/mm3
Show all 16Show fewer
- Viral load <50 copies/ml at screening
- Started cART after 2009 and on cART for at least one year prior to screening
- Willing to interrupt cART for up to 24weeks and change cART regimen if required
- 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)
- If heterosexually active and able to have children, willing to use a highly effective method of contraception with partner (combined oral contraceptive pill; injectable or implanted contraceptive; IUD/IUS; physiological or anatomical sterility (in self or partner) from 2 weeks before enrolment until 18 weeks after the last injection/infusion
- If women of childbearing potential*, willing to undergo urine pregnancy tests prior to administration of an injection or an infusion
- Willing to avoid all other vaccines within 4 weeks of scheduled study injections
- Willing and able to comply with visit schedule and provide blood samples
- Being covered by medical insurance or in National Healthcare System
- A woman will be considered of childbearing potential following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
Who cannot join
- Pregnant or lactating
- HIV-2 infection (either isolated or associated with HIV-1)
- VL >200 copies/ml on 2 occasions in the 12 months prior to screening
- Previous interruptions in cART
- Previous virological failures defined by loss of virological suppression with the presence of resistant mutations
- Haemoglobin (Hb <12g/dL for males, <11g/dL for females)
Show all 29Show fewer
- Concomitant or previous conditions that preclude injection of vaccines/infusion of monoclonal antibody and PML in the past
- History of experimental vaccinations against HIV
- Previous treatment with chemotherapy (except for chemotherapy injected into skin lesions for Kaposi's sarcoma)
- Treatment with systemic corticoids or immuno-suppressive agents ongoing or in the previous 12 weeks before randomisation in the trial
- Received natalizumab or rituximab ever in the past
- Received a TNF blocker in the past 60 days
- Administration of an inactivated vaccine within 30 days or a live vaccine within 60 days prior to randomisation
- Presence of a skin condition or marking that precludes inspection of the injection/infusion site
- History of cancer (except basal cellular skin carcinoma or Kaposi's sarcoma)
- History of significant neurological disease, cardiovascular disease (angina, myocardial infarction, transient ischemic attack, stroke); participants with controlled blood pressure are eligible
- Personal history of clinical autoimmune disease or reactive arthritis or family history of rheumatoid arthritis (parents or siblings)
- Ongoing diseases including uncontrolled active severe infection, cardiac, pulmonary (excluding mild asthma), thyroid, renal or neurological (peripheral or central) diseases
- Active or latent tuberculosis (unless prophylaxis in past as per local practice) - (participant must be screened for tuberculosis before starting infusions, according to routine practice)
- Presence of pathogenic bacteria or parasites in faeces at screening
- Participating in another biomedical research study within 30 days of randomisation.
- Known hypersensitivity to any component of the vaccine formulations used in this trial including aminoglycosides and eggs or have severe or multiple allergies to drugs or pharmaceutical agents, or any hypersensitivity to the active substance or to any of the excipients of vedolizumab
- Liver disease including hepatitis B (surface antigen positive) or hepatitis C (antigen or PCR positive)
- A clinically significant abnormality on ECG
- Hypernatraemia or hyperchloraemia
- History of severe local or general reaction to vaccination defined as
- local: extensive, indurated redness and swelling involving most of the arm, not resolving within 72 hours
- general: fever >= 39.5oC within 48 hours; anaphylaxis; bronchospasm; laryngeal oedema; collapse; convulsions or encephalopathy within 72 hours
- Grade 2 or worse routine laboratory parameters (see Appendix 4 for definitions). Hyperbilirubinaemia to be considered an exclusion criterion only when confirmed to be conjugated bilirubinaemia
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Phase I/II Randomised Therapeutic HIV Vaccine Trial in Individuals Who Started Antiretrovirals During Primary or Chronic Infection
EVHA T01 is an international, phase I/II, multicentre, multi-stage, double-blind study that will evaluate at least three experimental arms compared to placebo control in HIV-1 infected participants to see if one or more has a clinically relevant impact on the control of viral replication.
Read the detailed description
The randomization ratio is 1:1:1:1 for vaccine: vedolizumab: combination: placebo in one of 3 schedules.
The study contains a phase I component in order to evaluate the local and systemic reactogenicity following the first administration of products in the first 12 participants. The phase I will consist of a slow enrolment of the first 12 participants who will be randomised at a maximum rate of 1 per week for 4 weeks, then 2 per week for 4 weeks before increasing to 4 or more per week. The IDMC will review of cumulative adverse event data through to and including the first safety visit in the 12th participant and their recommendation will be sought with regard to expanding recruitment.
The phase II component will assess the effectiveness and safety of the three experimental strategies upon viral control following analytic treatment interruption (ATI). The phase II component is divided into two stages, an interim efficacy stage and a final efficacy stage. There will be a pause in enrolment after 88 participants have been enrolled. A planned interim review by the IDMC at the end of the first stage will provide an opportunity to modify the design of subsequent stages or the recruitment strategy.
Screening will take place during the 6 weeks prior to randomisation. Eligible participants will be enrolled at week 0 and randomised to vaccine, vedolizumab, the combination of vaccine and vedolizumab or matched placebos. Participants and study staff will be aware of the schedule the participant is randomised to, with a third allocated to injections, a third to infusions and a third to the combination of injections and infusions. Only staff authorised to prepare the products will know who is randomised to active product or placebo within each schedule in a ratio of 3:1 respectively.
The vaccine regimen will start at week 0 and the vedolizumab regimen at week 2, each with matched placebo.
Participants will continue on cART during the first 24 weeks covering the vaccination period and 5 of 6 vedolizumab/placebo infusions.
Treatment will then be interrupted and resumed when the viral load is confirmed to have rebounded to ≥10,000 copies/ml, or the CD4 falls to ≤350 cells/mm3, or there is evidence of disease progression, or they have completed 24 weeks of treatment interruption.
- Conditions
- HIV-1-infection
- Being tested
- GTU-MultiHIV B-clade vaccine + MVA HIV-B HIV vaccine, GTU-MultiHIV B-clade vaccine + MVA HIV-B HIV vaccine+ Vedolizumab, Vedolizumab 300 MG [Entyvio], Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GTU-MultiHIV B-clade vaccine + MVA HIV-B HIV vaccineBiological
The vaccine is a solution of HIV MVA vectors (see section 1.3.2) in S08 buffer (10mM Tris/hydrochloride (Tris/HCl), Saccharose 5% (w/v), 10mM Sodium Glutamate (Na Glu), 50mM Sodium Chloride (NaCl), water PPI, pH 8.0).
0.5ml of ANRS MVA HIV-B (1 x 108 pfu/ml) or placebo for MVA (S8 buffer) will be administered intramuscularly in the deltoid muscle of the non-dominant upper arm. Participants will be observed for one hour after the injection.
GTU-MultiHIV B-clade vaccine + MVA HIV-B HIV vaccine+ VedolizumabBiological
The vaccine is a solution of HIV MVA vectors (see section 1.3.2) in S08 buffer (10mM Tris/hydrochloride (Tris/HCl), Saccharose 5% (w/v), 10mM Sodium Glutamate (Na Glu), 50mM Sodium Chloride (NaCl), water PPI, pH 8.0).
0.5ml of ANRS MVA HIV-B (1 x 108 pfu/ml) or placebo for MVA (S8 buffer) will be administered intramuscularly in the deltoid muscle of the non-dominant upper arm. Participants will be observed for one hour after the injection. Vedolizumab is administered as an intravenous infusion over 30 mins in the dominant arm. After infusion, the line should be flushed with 30mls of normal saline.
Vedolizumab 300 MG [Entyvio]Drug
Vedolizumab is administered as an intravenous infusion over 30 mins in the dominant arm. After infusion, the line should be flushed with 30mls of normal saline.
PlaceboOther
Placebo for MVA it is a solution composed of S08 buffer (as for the MVA vaccine) that will be administered intramuscularly in the deltoid muscle of the non-dominant upper arm. Participants will be observed for one hour after the injection.
Placebo for GTU-MultiHIV B-clade vaccine: Sodium Chloride (NaCl) for infusion, 0.9%.
Placebo for Vedolizumab: Sodium Chloride (NaCl) for infusion, 0.9% in 250 ml infusion bags.
| Study group | Role | What they receive |
|---|---|---|
| Injection only: Active:placebo (3:1) | Experimental | GTU-MultiHIV B-clade + MVA HIV-B:
GTU-MultiHIV B-clade - 2 mg of DNA in 1ml encoding a multi HIV antigen (synthetic fusion protein) administered intramuscularly into the non-dominant deltoid muscle at weeks 0 and 4 and MVA HIV-B 0.5ml(1 x108 pfu/ml) MVA encoding the full-length codon-optimized sequence of Gag administered intramuscularly into the non-dominant deltoid muscle at week 12. Receives: Biological: GTU-MultiHIV B-clade vaccine + MVA HIV-B HIV vaccine; Biological: GTU-MultiHIV B-clade vaccine + MVA HIV-B HIV vaccine+ Vedolizumab |
| Infusion only: Active:placebo (3:1) | Experimental | Vedolizumab will be administered in the participant's dominant arm as an intravenous infusion over 30 mins. Receives: Drug: Vedolizumab 300 MG [Entyvio] |
| Injection and Infusion: Active:placebo (3:1) | Experimental | GTU-MultiHIV B-clade + MVA HIV-B + Vedolizumab Receives: Biological: GTU-MultiHIV B-clade vaccine + MVA HIV-B HIV vaccine; Biological: GTU-MultiHIV B-clade vaccine + MVA HIV-B HIV vaccine+ Vedolizumab; Drug: Vedolizumab 300 MG [Entyvio] |
| Placebo | Placebo comparator | Placebo1 for DNA: Sodium chloride for injection, 0.9% in 1ml administered intramuscularly into the non-dominant deltoid muscle at weeks 0 and 4.
Placebo 2 for MVA: S08 buffer in 0.5ml administered intramuscularly into the non-dominant deltoid muscle at week 12.
Placebo for mAb: Sodium Chloride (NaCl) for infusion, 0.9% in 250 ml infusion bags. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Time from treatment interruption to the earliest of reaching HIV RNA ≥ 10,000 copies/ml or resuming antiretroviral therapy for any reason over a period of 24 weeks.
Measured: Time from treatment interruption (scheduled for 12 weeks after completing the immunisation schedule) to the earliest of reaching HIV RNA ≥ 10,000 copies/ml or resuming antiretroviral therapy for any reason over a period of 24 weeks.
Safety: A clinical decision to discontinue the regimen for an adverse event that is considered related to product
Measured: From randomisation
Secondary outcomes (6)
Grade 3 and worse solicited clinical and laboratory adverse events
Measured: From randomisation to study completion, about 60 weeks.
Any event leading to interruption in the vaccine schedule
Measured: From randomisation to study completion, about 60 weeks.
Any event that results in resuming treatment during the ATI
Measured: From randomisation to study completion, about 60 weeks.
Serious Adverse Events
Measured: From randomisation to 30 days after the last protocol visit
Other clinical and laboratory adverse events
Measured: From randomisation to study completion, about 60 weeks.
Time to VL suppression after restarting ART
Measured: From randomisation to VL suppression after restarting ART
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2016 (estimated)
- Study start20 Feb 2019
- Primary completion11 Jul 2019
- Study completion11 Jul 2019
Why it stopped: Due to the bankruptcy of FITBiotech, the provider of the GTU DNA vaccine.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Collaborators
- European Commission, Swiss Government, Medical Research Council, FIT Biotech Ltd., Fred Hutchinson Cancer Center, University College, London, Centre Hospitalier Universitaire Vaudois, Imperial College London, Istituto Nazionale per le Malattie Infettive "Lazzaro Spallanzani" IRCCS, Universitätsklinikum Hamburg-Eppendorf, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Henri Mondor University Hospital, European Georges Pompidou Hospital, Saint-Louis Hospital, Paris, France
- Responsible party
- Sponsor
- Investigators
- Yves Levy, MD, Study director, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02972450
- Sponsor's protocol ID
- EHVA T01/ANRS VRI05
- Acronym
- EHVAT01
- Status last verified
- Aug 2019
- First submitted
- 10 Nov 2016
- Last updated
- 29 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Randomised Therapeutic HIV Vaccine Trial in Individuals Who Started Antiretrovirals During Primary or Chronic Infection
- ClinicalTrials.gov ID
- NCT02972450
- Acronym / sponsor ID
- EHVAT01 / EHVA T01/ANRS VRI05
- Conditions
- HIV-1-infection
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the bankruptcy of FITBiotech, the provider of the GTU DNA vaccine.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- European Commission, Swiss Government, Medical Research Council, FIT Biotech Ltd., Fred Hutchinson Cancer Center, University College, London, Centre Hospitalier Universitaire Vaudois, Imperial College London, Istituto Nazionale per le Malattie Infettive "Lazzaro Spallanzani" IRCCS, Universitätsklinikum Hamburg-Eppendorf, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Henri Mondor University Hospital, European Georges Pompidou Hospital, Saint-Louis Hospital, Paris, France
- Study start
- 20 Feb 2019 (actual)
- Primary completion
- 11 Jul 2019 (actual)
- Study completion
- 11 Jul 2019 (actual)
- First posted
- 23 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
EVHA T01 is an international, phase I/II, multicentre, multi-stage, double-blind study that will evaluate at least three experimental arms compared to placebo control in HIV-1 infected participants to see if one or more has a clinically relevant impact on the control of viral replication.
Detailed description
The randomization ratio is 1:1:1:1 for vaccine: vedolizumab: combination: placebo in one of 3 schedules.
The study contains a phase I component in order to evaluate the local and systemic reactogenicity following the first administration of products in the first 12 participants. The phase I will consist of a slow enrolment of the first 12 participants who will be randomised at a maximum rate of 1 per week for 4 weeks, then 2 per week for 4 weeks before increasing to 4 or more per week. The IDMC will review of cumulative adverse event data through to and including the first safety visit in the 12th participant and their recommendation will be sought with regard to expanding recruitment.
The phase II component will assess the effectiveness and safety of the three experimental strategies upon viral control following analytic treatment interruption (ATI). The phase II component is divided into two stages, an interim efficacy stage and a final efficacy stage. There will be a pause in enrolment after 88 participants have been enrolled. A planned interim review by the IDMC at the end of the first stage will provide an opportunity to modify the design of subsequent stages or the recruitment strategy.
Screening will take place during the 6 weeks prior to randomisation. Eligible participants will be enrolled at week 0 and randomised to vaccine, vedolizumab, the combination of vaccine and vedolizumab or matched placebos. Participants and study staff will be aware of the schedule the participant is randomised to, with a third allocated to injections, a third to infusions and a third to the combination of injections and infusions. Only staff authorised to prepare the products will know who is randomised to active product or placebo within each schedule in a ratio of 3:1 respectively.
The vaccine regimen will start at week 0 and the vedolizumab regimen at week 2, each with matched placebo.
Participants will continue on cART during the first 24 weeks covering the vaccination period and 5 of 6 vedolizumab/placebo infusions.
Treatment will then be interrupted and resumed when the viral load is confirmed to have rebounded to ≥10,000 copies/ml, or the CD4 falls to ≤350 cells/mm3, or there is evidence of disease progression, or they have completed 24 weeks of treatment interruption.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Injection only: Active:placebo (3:1) | Experimental | Biological: GTU-MultiHIV B-clade vaccine + MVA HIV-B HIV vaccine, Biological: GTU-MultiHIV B-clade vaccine + MVA HIV-B HIV vaccine+ VedolizumabGTU-MultiHIV B-clade + MVA HIV-B: GTU-MultiHIV B-clade - 2 mg of DNA in 1ml encoding a multi HIV antigen (synthetic fusion protein) administered intramuscularly into the non-dominant deltoid muscle at weeks 0 and 4 and MVA HIV-B 0.5ml(1 x108 pfu/ml) MVA encoding the full-length codon-optimized sequence of Gag administered intramuscularly into the non-dominant deltoid muscle at week 12. |
| Infusion only: Active:placebo (3:1) | Experimental | Drug: Vedolizumab 300 MG [Entyvio]Vedolizumab will be administered in the participant's dominant arm as an intravenous infusion over 30 mins. |
| Injection and Infusion: Active:placebo (3:1) | Experimental | Biological: GTU-MultiHIV B-clade vaccine + MVA HIV-B HIV vaccine, Biological: GTU-MultiHIV B-clade vaccine + MVA HIV-B HIV vaccine+ Vedolizumab, Drug: Vedolizumab 300 MG [Entyvio]GTU-MultiHIV B-clade + MVA HIV-B + Vedolizumab |
| Placebo | Placebo comparator | Other: PlaceboPlacebo1 for DNA: Sodium chloride for injection, 0.9% in 1ml administered intramuscularly into the non-dominant deltoid muscle at weeks 0 and 4. Placebo 2 for MVA: S08 buffer in 0.5ml administered intramuscularly into the non-dominant deltoid muscle at week 12. Placebo for mAb: Sodium Chloride (NaCl) for infusion, 0.9% in 250 ml infusion bags. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- HIV-1-infected
- Aged 18 - 65 years old on the day of screening
- Weight >50kg
- Willing and able to provide written informed consent
- Nadir CD4 count > 300 cells/mm3
Key exclusion criteria (29 listed)
- Pregnant or lactating
- HIV-2 infection (either isolated or associated with HIV-1)
- VL >200 copies/ml on 2 occasions in the 12 months prior to screening
- Previous interruptions in cART
- Previous virological failures defined by loss of virological suppression with the presence of resistant mutations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GTU-MultiHIV B-clade vaccine + MVA HIV-B HIV vaccineThe vaccine is a solution of HIV MVA vectors (see section 1.3.2) in S08 buffer (10mM Tris/hydrochloride (Tris/HCl), Saccharose 5% (w/v), 10mM Sodium Glutamate (Na Glu), 50mM Sodium Chloride (NaCl), water PPI, pH 8.0). 0.5ml of ANRS MVA HIV-B (1 x 108 pfu/ml) or placebo for MVA (S8 buffer) will be administered intramuscularly in the deltoid muscle of the non-dominant upper arm. Participants will be observed for one hour after the injection. | Biological | Injection and Infusion: Active:placebo (3:1), Injection only: Active:placebo (3:1) |
| GTU-MultiHIV B-clade vaccine + MVA HIV-B HIV vaccine+ VedolizumabThe vaccine is a solution of HIV MVA vectors (see section 1.3.2) in S08 buffer (10mM Tris/hydrochloride (Tris/HCl), Saccharose 5% (w/v), 10mM Sodium Glutamate (Na Glu), 50mM Sodium Chloride (NaCl), water PPI, pH 8.0). 0.5ml of ANRS MVA HIV-B (1 x 108 pfu/ml) or placebo for MVA (S8 buffer) will be administered intramuscularly in the deltoid muscle of the non-dominant upper arm. Participants will be observed for one hour after the injection. Vedolizumab is administered as an intravenous infusion over 30 mins in the dominant arm. After infusion, the line should be flushed with 30mls of normal saline. | Biological | Injection and Infusion: Active:placebo (3:1), Injection only: Active:placebo (3:1) |
| Vedolizumab 300 MG [Entyvio]Vedolizumab is administered as an intravenous infusion over 30 mins in the dominant arm. After infusion, the line should be flushed with 30mls of normal saline. | Drug | Infusion only: Active:placebo (3:1), Injection and Infusion: Active:placebo (3:1) |
| PlaceboPlacebo for MVA it is a solution composed of S08 buffer (as for the MVA vaccine) that will be administered intramuscularly in the deltoid muscle of the non-dominant upper arm. Participants will be observed for one hour after the injection. Placebo for GTU-MultiHIV B-clade vaccine: Sodium Chloride (NaCl) for infusion, 0.9%. Placebo for Vedolizumab: Sodium Chloride (NaCl) for infusion, 0.9% in 250 ml infusion bags. | Other | Placebo |
Primary outcome
Efficacy: Time from treatment interruption to the earliest of reaching HIV RNA ≥ 10,000 copies/ml or resuming antiretroviral therapy for any reason over a period of 24 weeks.
Time frame: Time from treatment interruption (scheduled for 12 weeks after completing the immunisation schedule) to the earliest of reaching HIV RNA ≥ 10,000 copies/ml or resuming antiretroviral therapy for any reason over a period of 24 weeks.
Safety: A clinical decision to discontinue the regimen for an adverse event that is considered related to product
Time frame: From randomisation
6 secondary outcomes
Grade 3 and worse solicited clinical and laboratory adverse events
Time frame: From randomisation to study completion, about 60 weeks.
Any event leading to interruption in the vaccine schedule
Time frame: From randomisation to study completion, about 60 weeks.
Any event that results in resuming treatment during the ATI
Time frame: From randomisation to study completion, about 60 weeks.
Serious Adverse Events
Time frame: From randomisation to 30 days after the last protocol visit
Other clinical and laboratory adverse events
Time frame: From randomisation to study completion, about 60 weeks.
Time to VL suppression after restarting ART
Time frame: From randomisation to VL suppression after restarting ART
Results and safety
The study was stopped early (reason given: Due to the bankruptcy of FITBiotech, the provider of the GTU DNA vaccine.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2019.
- Individual participant dataSharing planned: No
Related trials for HIV-1-infection
RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
HIV-1-infection
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
Active, not recruitingPhase 3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
HIV-1-infection
Active, not recruitingPhase 2/3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (ARTISTRY-1)
HIV-1-infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yves Levy, MD study director
Institut National de la Santé Et de la Recherche Médicale, France
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GTU-MultiHIV B-clade vaccine + MVA HIV-B HIV vaccine, GTU-MultiHIV B-clade vaccine + MVA HIV-B HIV vaccine+ Vedolizumab and Vedolizumab 300 MG [Entyvio] in people with HIV-1-infection, run by ANRS, Emerging Infectious Diseases at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Due to the bankruptcy of FITBiotech, the provider of the GTU DNA vaccine.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy: Time from treatment interruption to the earliest of reaching HIV RNA ≥ 10,000 copies/ml or resuming antiretroviral therapy for any reason over a period of 24 weeks. (time frame: Time from treatment interruption (scheduled for 12 weeks after completing the immunisation schedule) to the earliest of reaching HIV RNA ≥ 10,000 copies/ml or resuming antiretroviral therapy for any reason over a period of 24 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2019.