AIDSPhase 1/2EVATATNCT01793818
Evaluation on Seropositive Patients of a Synthetic Vaccine Targeting the HIV Tat Protein
A Phase 1/2 study testing Tat Oyi in people with AIDS, run by BIOSANTECH at 1 site in France.
Trial summary
Tat Oyi vaccination on seropositive patients could help their immune system to recognize and neutralize Tat. The neutralization of extra cellular Tat should help the cellular immune response to eliminate HIV-1 infected cells. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- AIDS
- What is being tested?
- Tat Oyi
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2013to Mar 2016
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age from 18 to 64 years old for the pre inclusion visit.
- Documented HIV-1 Infection
- Preferentially, group A patients from CDC classification but no group C patients.
- HIV-1 patients treated with three antiretroviral drugs since 12 months not changed since three months and having an undetectable viremia since 12 months.
- HIV-1 Chronic infection defined by a positive HIV-1 ELISA and HIV-1 proteins characterized in a full HIV-1 Western blot. Stable undetectable plasmatic HIV RNA (lower than 40 copies/ml) since 12 months. Lymphocyte CD4 cells higher than 350/mm3 with a NADIR higher than 200/mm3 since 12 months.
- Free engagement, fully explained and wrote with the patient signature for the inclusion visit and before any test required for the clinical trial.
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- Patient affiliated to a social security system.
- No vaccination against influenza or other pathogens since three months.
- No chemotherapy or treatments with corticosteroid
- HIV-1 patients being abstinent former drug users or drug users following substitution training.
Who cannot join
- HIV-1 patient protected regarding French law (articles L1121-5, L1121-6, L1121-7, L1121-8 \& L1122-2)
- No HIV-1 infection
- Patient infected with HIV-2
- Patient in HIV-1 primo infection or recently in primo infection
- Patient in symptomatic primo infection or CD4 cells lower than 200/mm3
- Women sexually active with no efficient contraception
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- Pregnant women or brass feeding.
- Patient with an opportunistic infection in the CDC group C.
- Patient with a cancer and/or under chemotherapy or radiotherapy.
- Patient with an evolutive psychiatric pathology
- Patient being HBV and/or HCV positive
- Patient being ELISA positive for HTLV-1
- Patient being cirrhotic (Child and Pugh level A, B and C)
- Patient under criminal investigation
- Patients with abnormal blood formulation
- Patient participating to another clinical research
Trial locations and contacts
1 site in 1 country.
France1 site
Centre d'Investigation Clinique - Universitary Hospital Centre Conception
Marseille, 13385
About this study
Tat Oyi vaccination on seropositive patients could help their immune system to recognize and neutralize Tat. The neutralization of extra cellular Tat should help the cellular immune response to eliminate HIV-1 infected cells.
Read the detailed description
The protocol got a favorable judgment from an ethic committee (CPP SudMed 2) on November 9th, 2012 and was authorized by the French drug agency (ANSM) on January 24th, 2013. It will be proposed to HIV-1 infected volunteers to participate to a phase I/II clinical trial to test the Tat Oyi vaccine. Volunteers will have an undetectable viremia (lower than 40 copies/ml) and a level of CD4 cells higher than 350 /mm3 since at least one year under Anti Retroviral Treatment (ART). It will be a randomized double blinded clinical trial with a placebo.
Main Objective: No undesirable events due to vaccination and viremia remaining < 100 copies/ml after interruption of cART.
Secondary objective: An immune response against Tat characterized by the cross recognition of Tat variants representative of the five main HIV-1 clades.
Main parameter of evaluation: Plasma viremia. Secondary parameter of evaluation: Detection with ELISA of antibodies able to recognize Tat variants representative of the five main HIV-1 clades.
- Conditions
- AIDS
- Being tested
- Tat Oyi
- Keywords
- Vaccine, HIV-1, Tat
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tat OyiBiological
Three injections in the arm
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Phase I/II | Placebo comparator | Three injections with no active principle Receives: Biological: Tat Oyi |
| Group 2 Phase I/II | Active comparator | Three injections of Tat Oyi vaccine containing 11 µg of active principle Receives: Biological: Tat Oyi |
| Group 3 Phase I/II | Active comparator | Three injections Tat Oyi vaccine containing 33 µg of active principle Receives: Biological: Tat Oyi |
| Group 4 Phase I/II | Active comparator | Three injections Tat Oyi vaccine containing 99 µg of active principle Receives: Biological: Tat Oyi |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal vaccine dose (phase I/II)
No undesirable events due to vaccination and viremia remaining < 100 copies/ml after interruption of ART.
Measured: Two years
Secondary outcomes (1)
Optimal Vaccine Dose (phase I/II)
An immune response against Tat characterized by the cross recognition of Tat variants representative of the five main HIV-1 clades.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionMar 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AIDSStudies of the same condition, open and under way.
- 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, Care provider
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- BIOSANTECH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Assistance Publique Hopitaux De Marseille
- Responsible party
- Sponsor
- Investigators
- Isabelle Ravaux, MD, Principal investigator, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01793818
- Sponsor's protocol ID
- EVATAT
- Acronym
- EVATAT
- Status last verified
- Feb 2016
- First submitted
- 14 Feb 2013
- Last updated
- 10 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data base (HIV RNA, CD4, CD8, HIV DNA, Tat immune response) and statistical analysis
Publications
Loret E. HIV extracellular Tat: myth or reality? Curr HIV Res. 2015;13(2):90-7. doi: 10.2174/1570162x12666141202125643.
PubMed 25439235
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation on Seropositive Patients of a Synthetic Vaccine Targeting the HIV Tat Protein
- ClinicalTrials.gov ID
- NCT01793818
- Acronym / sponsor ID
- EVATAT / EVATAT
- Conditions
- AIDS
- Keywords
- Vaccine, HIV-1, Tat
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- BIOSANTECHIndustry (pharma, biotech, devices)
- Collaborators
- Assistance Publique Hopitaux De Marseille
- Study start
- Feb 2013
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 18 Feb 2013 (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.
Tat Oyi vaccination on seropositive patients could help their immune system to recognize and neutralize Tat. The neutralization of extra cellular Tat should help the cellular immune response to eliminate HIV-1 infected cells.
Detailed description
The protocol got a favorable judgment from an ethic committee (CPP SudMed 2) on November 9th, 2012 and was authorized by the French drug agency (ANSM) on January 24th, 2013. It will be proposed to HIV-1 infected volunteers to participate to a phase I/II clinical trial to test the Tat Oyi vaccine. Volunteers will have an undetectable viremia (lower than 40 copies/ml) and a level of CD4 cells higher than 350 /mm3 since at least one year under Anti Retroviral Treatment (ART). It will be a randomized double blinded clinical trial with a placebo.
Main Objective: No undesirable events due to vaccination and viremia remaining < 100 copies/ml after interruption of cART.
Secondary objective: An immune response against Tat characterized by the cross recognition of Tat variants representative of the five main HIV-1 clades.
Main parameter of evaluation: Plasma viremia. Secondary parameter of evaluation: Detection with ELISA of antibodies able to recognize Tat variants representative of the five main HIV-1 clades.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 Phase I/II | Placebo comparator | Biological: Tat OyiThree injections with no active principle |
| Group 2 Phase I/II | Active comparator | Biological: Tat OyiThree injections of Tat Oyi vaccine containing 11 µg of active principle |
| Group 3 Phase I/II | Active comparator | Biological: Tat OyiThree injections Tat Oyi vaccine containing 33 µg of active principle |
| Group 4 Phase I/II | Active comparator | Biological: Tat OyiThree injections Tat Oyi vaccine containing 99 µg of active principle |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Age from 18 to 64 years old for the pre inclusion visit.
- Documented HIV-1 Infection
- Preferentially, group A patients from CDC classification but no group C patients.
- HIV-1 patients treated with three antiretroviral drugs since 12 months not changed since three months and having an undetectable viremia since 12 months.
- HIV-1 Chronic infection defined by a positive HIV-1 ELISA and HIV-1 proteins characterized in a full HIV-1 Western blot. Stable undetectable plasmatic HIV RNA (lower than 40 copies/ml) since 12 months. Lymphocyte CD4 cells higher than 350/mm3 with a NADIR higher than 200/mm3 since 12 months.
Key exclusion criteria (16 listed)
- HIV-1 patient protected regarding French law (articles L1121-5, L1121-6, L1121-7, L1121-8 \& L1122-2)
- No HIV-1 infection
- Patient infected with HIV-2
- Patient in HIV-1 primo infection or recently in primo infection
- Patient in symptomatic primo infection or CD4 cells lower than 200/mm3
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 |
|---|---|---|
| Tat OyiThree injections in the arm | Biological | Group 1 Phase I/II, Group 2 Phase I/II, Group 3 Phase I/II, Group 4 Phase I/II |
Primary outcome
Optimal vaccine dose (phase I/II)
Time frame: Two years
No undesirable events due to vaccination and viremia remaining < 100 copies/ml after interruption of ART.
1 secondary outcome
Optimal Vaccine Dose (phase I/II)
Time frame: Two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2016.
- Background: PubMed 25439235Loret E. HIV extracellular Tat: myth or reality? Curr HIV Res. 2015;13(2):90-7. doi: 10.2174/1570162x12666141202125643.
- Individual participant dataSharing planned: Yes. Data base (HIV RNA, CD4, CD8, HIV DNA, Tat immune response) and statistical analysis
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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.
Isabelle Ravaux, MD principal investigator
Assistance Publique Hopitaux De Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Tat Oyi in people with AIDS, run by BIOSANTECH at 1 site in France.
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 10 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 10 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
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?
Optimal vaccine dose (phase I/II) (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01793818, which also lists 1 linked publication.
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 10 Feb 2016.