HIV InfectionPhase 1/2NCT02054286
Safety, Tolerability and Immunogenicity Induced by the THV01 Treatment in Patients Infected With HIV-1 Clade B and Treated With Highly Active Antiretroviral Therapy (HAART).
A Phase 1/2 study testing THV01-1 and THV01-2 in people with HIV Infection, run by Theravectys S.A. at 11 sites in 2 countries.
Trial summary
The objectives of this Phase I/II trial is to evaluate the safety, tolerability and immunogenicity of THV01 compared to placebo in HIV-1 infected patients on HAART (highly active antiretroviral therapies). THV01 is composed of two vaccines that derived from the HIV (human immunodeficiency virus): lentiviral vectors. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- HIV Infection
- What is being tested?
- THV01-1 and THV01-2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 11 sitesin 2 countries
- Study dates
- Dec 2012to 27 Feb 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients infected with clade B HIV-1;
- Confirmation of a Gag clade B genotyping performed at screening;
- Patient must be treated by a triple agents therapy for more than 12 months at baseline: this triple agents therapy should encompasses two (2) nucleosidic reverse transcriptase inhibitors plus one (1) boosted protease inhibitor, or two (2) nucleosidic reverse transcriptase inhibitors plus one (1) non nucleosidic reverse transcriptase inhibitor;
- Patients must be treated for more than 60 days at baseline by two (2) nucleosidic reverse transcriptase inhibitors plus a ritonavir boosted protease inhibitor treatment among darunavir+ritonavir or lopinavir+ritonavir;
- Patients' HIV plasma viral load ≤150,000 copies mL-1 at any monitoring time (apart measurement during primo-infection if recorded);
- Patients with HIV plasma viral load persistently ≤ 50 copies mL-1 during the 12 months prior to screening;
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- Patients' CD4+ T cells count ≥ 300 cells per mm3 at any time since diagnosis;
- Patient's CD4+ T cells count < 500 cells per mm3 at least once from diagnosis to initiation of antiretroviral treatment;
- Patients with CD4+ T cells count ≥ 600 cells per mm3 at baseline;
- Man or woman aged 18-55 years;
Who cannot join
- HIV-2 infection;
- Patient treated by HIV entry of fusion inhibitors;
- Patient treated by HIV integrase inhibitors;
- Patient displaying any HIV protease inhibitor resistance mutation as listed in the current version of the HIV drug resistance database (Stanford University);
- Patient having undergone virological failure as defined by a viral load ≥ 500 copies mL-1 confirmed by a second measure, since initiation of treatment;
- More than 2 blips with viral load comprised between 50 and 500 copies mL-1 during the 12 months prior inclusion;
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- History of an AIDS-defining clinical illness;
- Concomitant AIDS-related opportunistic disease;
- History of allergic disease, anaphylaxis or reactions likely to be triggered or exacerbated by any component of the vaccine such as lactose;
- Acute or chronic infectious disease other than AIDS (include but not limited to viral hepatitis such as hepatitis B and hepatitis C, active tuberculosis, active syphilis, HTLV-1, HTLV-2);
- Acute, chronic or history of clinically relevant pulmonary, cardiovascular, gastrointestinal, hepatic, pancreatic or renal functional abnormality, encephalopathy, neuropathy or unstable CNS pathology, angina or cardiac arrhythmias, or any other clinically significant medical problems as determined by physical examination and/or laboratory screening tests and/or medical history;
- Severe hepatic impairment;
- Serious dyslipidaemia;
- Severe disorders of blood coagulation;
- Known or suspected allergy to egg phospholipids, soy proteins and/or peanut;
- Acute, chronic or history of immunodeficiency or autoimmune disease other than HIV infection;
- Unstable asthma (defined as sudden acute attacks occurring in less than three hours without an obvious trigger, hospitalisation for asthma in the last two years); food or wine induced asthma;
- History of malignancy unless there has been surgical excision that is considered to have achieved cure;
- Active malignancy that may require chemotherapy or radiation therapy;
- Seizure disorder or any history of prior seizure;
- Subjects planning to receive a prophylactic or therapeutic vaccination during the study except Influenza immunization;
- Subjects who have received any vaccination for the 3 months prior the first injection;
- Subjects having an infective exacerbation as defined as a requirement of inhaled, oral, or intravenous antibiotics at W-2 or later;
- Serious illness requiring systemic treatment and/or hospitalization within 7 days prior to baseline;
- Pregnant or breast-feeding woman;
- Any contraindication of intramuscular injection;
- Active drug or alcohol abuse or dependence;
- Any condition, which in the opinion of the investigator, could compromise the subject's safety or adherence to the study protocol.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
France9 sites
CHU Clermont-Ferrand
Clermont-Ferrand, 65003
CHU Dijon
Dijon, 21079
CHU Croix-Rousse
Lyon, 69317
Hôpital Saint-Louis
Paris, 75010
CIC Cochin-Pasteur; Hôpital Cochin
Paris, 75014
CHU Rennes
Rennes, 35033
Hôpital Nord
Saint-Etienne, 42055
CHU Strasbourg
Strasbourg, 6091
Hôpital Purpan
Toulouse, 31059
About this study
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled Phase I/II Trial to Compare the Safety, Tolerability and Immunogenicity of the Therapeutic THV01 Vaccination at 5.10E+6 TU (Transducing Unit) , 5.10E+7 TU (Transducing Unit) or 5.10E+8 TU (Transducing Unit) Doses to Placebo in HIV-1 Clade B Infected Patients Under Highly Active Antiretroviral Therapy (HAART)
The objectives of this Phase I/II trial is to evaluate the safety, tolerability and immunogenicity of THV01 compared to placebo in HIV-1 infected patients on HAART (highly active antiretroviral therapies).
THV01 is composed of two vaccines that derived from the HIV (human immunodeficiency virus): lentiviral vectors. They are non-replicative and not infectious. They will be injected intramuscularly, eight weeks apart. Three doses will be assessed and compared to placebo.
Read more
Eligible patients must have an undetectable viral load and must be treated by HAART for more than 12 months. They will be randomly allocated to one of the study group and will receive the experimental drugs at one of the three doses or a matching placebo.
Their anti-HIV treatment will be alleviated around each experimental drugs' administration to enable THV01 efficacy. HAART will be resumed one week after the second injection. 15 weeks after resumption, HAART will be interrupted. Patients will then be monitored every 2 weeks for CD4+ T cell counts and viral load as well as for thorough assessment of the elicited immune response. Stringent anti-HIV treatments resumption criteria have been implemented, based on the CD4+ T cell counts and the viral load.
38 patients were enrolled in THV01-11-01 study and received the 2 injections.
A long-term follow-up of all enrolled patients will be performed for 5 years post-prime administration. This will provide additional data on the safety and the potential long-term risks/benefits associated with THV01.
The final study report will be written after the last patient last visit in the long-term follow-up.
Read the detailed description
This Phase I/II is a randomized, double-blind and placebo controlled study to assess safety, tolerability and immunogenicity of THV01 at three doses in patients infected with the HIV-1 clade B currently on HAART (highly active antiretroviral therapies).
THV01 involves two intramuscular injections, consisting of the THV01-1 and THV01-2 lentiviral vectors, to be administered intramuscularly eight weeks apart. These lentiviral vectors are non-replicative and self-inactivating. Both encode the same HIV antigen.
36 patients were planned to be enrolled. They must be HIV-1 (clade B) infected patients, treated by HAART for more than 12 months and with an undetectable viral load.
Patients will be randomly allocated to one of the groups:
- Group 1: patients will receive the THV01-1 and THV01-2 vaccines at 5.10E+6 TU (transducing unit) or placebo;
- Group 2: patients will receive the THV01-1 and THV01-2 vaccines at 5.10E+7 TU (transducing unit) or placebo;
- Group 3: patients will receive the THV01-1 and THV01-2 vaccines at 5.10E+8 TU (transducing unit) or placebo.
Hence, twelve patients will be randomized in blocks of 4 in a 3:1 ratio (vaccine:placebo) for each dose.
Experimental drugs' injection will occur at Week 0 and Week 8. HAART will be alleviated for all patients during this "vaccination phase" to enable efficient transduction of the host cells by the lentiviral vectors. Initial HAART will be resumed at Week 9.
Starting on Week 24, HAART will be interrupted. Patients will then be monitored on a very stringent rhythm. HAART resumption criteria based on the CD4+ T cell counts and the viral load have been implemented to guaranty safety of all enrolled patients.
38 patients were enrolled in THV01-11-01 study and received the 2 injections.
A long-term follow-up of all enrolled patients will be performed for 5 years after the administration of THV01-1. During this follow-up, three visits are planned per year, during which blood will be sampled. This will provide data on the long-term safety of THV01 and the potential long-term risks/benefits associated with THV01.
- Conditions
- HIV Infection
- Being tested
- THV01-1, THV01-2, Placebo
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THV01-1Biological
Also called lentiviral vector ancoding an HIV antigen
Intramuscular injection of THV01-1 (week 0)
THV01-2Biological
Also called lentiviral vector encoding an HIV antigen
Intramuscular injection of THV01-2 (week 8)
PlaceboBiological
Also called Placebo matching THV01-1 and THV01-2
Intramuscular injection of placebo matching THV01-1 and THV01-2
| Study group | Role | What they receive |
|---|---|---|
| Group 1: THV01 (5.10E+6 TU) or Placebo | Experimental | 5.10E+6 TU (transducing unit) of THV01-1 (Week 0) OR matching placebo; 5.10E+6 TU (transducing unit) of THV01-2 (Week 8) OR matching placebo Receives: Biological: THV01-1; Biological: THV01-2; Biological: Placebo |
| Group 2: THV01 (5.10E+7 TU) or Placebo | Experimental | 5.10E+7 TU (transducing unit) of THV01-1 (Week 0) OR matching placebo; 5.10E+7 TU (transducing unit) of THV01-2 (Week 8) OR matching placebo Receives: Biological: THV01-1; Biological: THV01-2; Biological: Placebo |
| Group 3: THV01 (5.10E+8 TU) or Placebo | Experimental | 5.10E+8 TU (transducing unit) of THV01-1 (Week 0) OR matching placebo; 5.10E+8 TU (transducing unit) of THV01-2 (Week 8) OR matching placebo Receives: Biological: THV01-1; Biological: THV01-2; Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
Occurrence of at least one grade 3 or higher adverse event including signs/symptoms, laboratory toxicities and/or clinical events possibly, probably or definitely related to study treatment.
Measured: From Week 0 to Week 24
Secondary outcomes (2)
Safety and tolerability
Occurrence of at least one grade 3 or higher adverse event including signs/symptoms, laboratory toxicities and/or clinical events possibly, probably or definitely related to study treatment.
Measured: From baseline to Week 88 (or early termination).
Immunogenicity
Monitoring the cellular immune response by treatment group versus placebo.
Measured: From baseline to Week 88 (or early termination).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2014 (estimated)
- Study startDec 2012
- Primary completionAug 2014
- Study completion27 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theravectys S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Odile Launay, Pr, Principal investigator, CIC Cochin-Pasteur; Hôpital Cochin; Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02054286
- Sponsor's protocol ID
- THV01-11-01
- Status last verified
- Apr 2019
- First submitted
- 1 Feb 2014
- Last updated
- 11 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Placebo-controlled Phase I/II Trial to Compare the Safety, Tolerability and Immunogenicity of the Therapeutic THV01 Vaccination at 5.10E+6 TU (Transducing Unit) , 5.10E+7 TU (Transducing Unit) or 5.10E+8 TU (Transducing Unit) Doses to Placebo in HIV-1 Clade B Infected Patients Under Highly Active Antiretroviral Therapy (HAART)
- ClinicalTrials.gov ID
- NCT02054286
- Acronym / sponsor ID
- THV01-11-01
- Conditions
- HIV Infection
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Theravectys S.A.Industry (pharma, biotech, devices)
- Study start
- Dec 2012 (actual)
- Primary completion
- Aug 2014 (actual)
- Study completion
- 27 Feb 2019 (actual)
- First posted
- 4 Feb 2014 (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.
The objectives of this Phase I/II trial is to evaluate the safety, tolerability and immunogenicity of THV01 compared to placebo in HIV-1 infected patients on HAART (highly active antiretroviral therapies).
THV01 is composed of two vaccines that derived from the HIV (human immunodeficiency virus): lentiviral vectors. They are non-replicative and not infectious. They will be injected intramuscularly, eight weeks apart. Three doses will be assessed and compared to placebo.
Eligible patients must have an undetectable viral load and must be treated by HAART for more than 12 months. They will be randomly allocated to one of the study group and will receive the experimental drugs at one of the three doses or a matching placebo.
Their anti-HIV treatment will be alleviated around each experimental drugs' administration to enable THV01 efficacy. HAART will be resumed one week after the second injection. 15 weeks after resumption, HAART will be interrupted. Patients will then be monitored every 2 weeks for CD4+ T cell counts and viral load as well as for thorough assessment of the elicited immune response. Stringent anti-HIV treatments resumption criteria have been implemented, based on the CD4+ T cell counts and the viral load.
38 patients were enrolled in THV01-11-01 study and received the 2 injections.
A long-term follow-up of all enrolled patients will be performed for 5 years post-prime administration. This will provide additional data on the safety and the potential long-term risks/benefits associated with THV01.
The final study report will be written after the last patient last visit in the long-term follow-up.
Detailed description
This Phase I/II is a randomized, double-blind and placebo controlled study to assess safety, tolerability and immunogenicity of THV01 at three doses in patients infected with the HIV-1 clade B currently on HAART (highly active antiretroviral therapies).
THV01 involves two intramuscular injections, consisting of the THV01-1 and THV01-2 lentiviral vectors, to be administered intramuscularly eight weeks apart. These lentiviral vectors are non-replicative and self-inactivating. Both encode the same HIV antigen.
36 patients were planned to be enrolled. They must be HIV-1 (clade B) infected patients, treated by HAART for more than 12 months and with an undetectable viral load.
Patients will be randomly allocated to one of the groups:
- Group 1: patients will receive the THV01-1 and THV01-2 vaccines at 5.10E+6 TU (transducing unit) or placebo;
- Group 2: patients will receive the THV01-1 and THV01-2 vaccines at 5.10E+7 TU (transducing unit) or placebo;
- Group 3: patients will receive the THV01-1 and THV01-2 vaccines at 5.10E+8 TU (transducing unit) or placebo.
Hence, twelve patients will be randomized in blocks of 4 in a 3:1 ratio (vaccine:placebo) for each dose.
Experimental drugs' injection will occur at Week 0 and Week 8. HAART will be alleviated for all patients during this "vaccination phase" to enable efficient transduction of the host cells by the lentiviral vectors. Initial HAART will be resumed at Week 9.
Starting on Week 24, HAART will be interrupted. Patients will then be monitored on a very stringent rhythm. HAART resumption criteria based on the CD4+ T cell counts and the viral load have been implemented to guaranty safety of all enrolled patients.
38 patients were enrolled in THV01-11-01 study and received the 2 injections.
A long-term follow-up of all enrolled patients will be performed for 5 years after the administration of THV01-1. During this follow-up, three visits are planned per year, during which blood will be sampled. This will provide data on the long-term safety of THV01 and the potential long-term risks/benefits associated with THV01.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: THV01 (5.10E+6 TU) or Placebo | Experimental | Biological: THV01-1, Biological: THV01-2, Biological: Placebo5.10E+6 TU (transducing unit) of THV01-1 (Week 0) OR matching placebo; 5.10E+6 TU (transducing unit) of THV01-2 (Week 8) OR matching placebo |
| Group 2: THV01 (5.10E+7 TU) or Placebo | Experimental | Biological: THV01-1, Biological: THV01-2, Biological: Placebo5.10E+7 TU (transducing unit) of THV01-1 (Week 0) OR matching placebo; 5.10E+7 TU (transducing unit) of THV01-2 (Week 8) OR matching placebo |
| Group 3: THV01 (5.10E+8 TU) or Placebo | Experimental | Biological: THV01-1, Biological: THV01-2, Biological: Placebo5.10E+8 TU (transducing unit) of THV01-1 (Week 0) OR matching placebo; 5.10E+8 TU (transducing unit) of THV01-2 (Week 8) OR matching placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Patients infected with clade B HIV-1;
- Confirmation of a Gag clade B genotyping performed at screening;
- Patient must be treated by a triple agents therapy for more than 12 months at baseline: this triple agents therapy should encompasses two (2) nucleosidic reverse transcriptase inhibitors plus one (1) boosted protease inhibitor, or two (2) nucleosidic reverse transcriptase inhibitors plus one (1) non nucleosidic reverse transcriptase inhibitor;
- Patients must be treated for more than 60 days at baseline by two (2) nucleosidic reverse transcriptase inhibitors plus a ritonavir boosted protease inhibitor treatment among darunavir+ritonavir or lopinavir+ritonavir;
- Patients' HIV plasma viral load ≤150,000 copies mL-1 at any monitoring time (apart measurement during primo-infection if recorded);
Key exclusion criteria (28 listed)
- HIV-2 infection;
- Patient treated by HIV entry of fusion inhibitors;
- Patient treated by HIV integrase inhibitors;
- Patient displaying any HIV protease inhibitor resistance mutation as listed in the current version of the HIV drug resistance database (Stanford University);
- Patient having undergone virological failure as defined by a viral load ≥ 500 copies mL-1 confirmed by a second measure, since initiation of treatment;
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 |
|---|---|---|
| THV01-1Also: lentiviral vector ancoding an HIV antigenIntramuscular injection of THV01-1 (week 0) | Biological | Group 1: THV01 (5.10E+6 TU) or Placebo, Group 2: THV01 (5.10E+7 TU) or Placebo, Group 3: THV01 (5.10E+8 TU) or Placebo |
| THV01-2Also: lentiviral vector encoding an HIV antigenIntramuscular injection of THV01-2 (week 8) | Biological | Group 1: THV01 (5.10E+6 TU) or Placebo, Group 2: THV01 (5.10E+7 TU) or Placebo, Group 3: THV01 (5.10E+8 TU) or Placebo |
| PlaceboAlso: Placebo matching THV01-1 and THV01-2Intramuscular injection of placebo matching THV01-1 and THV01-2 | Biological | Group 1: THV01 (5.10E+6 TU) or Placebo, Group 2: THV01 (5.10E+7 TU) or Placebo, Group 3: THV01 (5.10E+8 TU) or Placebo |
Primary outcome
Safety and tolerability
Time frame: From Week 0 to Week 24
Occurrence of at least one grade 3 or higher adverse event including signs/symptoms, laboratory toxicities and/or clinical events possibly, probably or definitely related to study treatment.
2 secondary outcomes
Safety and tolerability
Time frame: From baseline to Week 88 (or early termination).
Immunogenicity
Time frame: From baseline to Week 88 (or early termination).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2019.
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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.
Odile Launay, Pr principal investigator
CIC Cochin-Pasteur; Hôpital Cochin; Paris
11 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 THV01-1 and THV01-2 in people with HIV Infection, run by Theravectys S.A. at 11 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 10 inclusion and 28 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: finished, as of the sponsor's last update on 11 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France, Belgium. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety and tolerability (time frame: From Week 0 to Week 24). 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 11 Apr 2019.