HIV/AIDSPhase 2AELIX-003NCT04364035
Safety, Tolerability and Immunogenicity of MVA.HTI and ChAdOx1.HTI With Vesatolimod in HIV-1 Positive Patients
A Phase 2 study testing ChAdOx1.HTI, MVA.HTI and GS-9620 in people with HIV/AIDS, run by Aelix Therapeutics at 9 sites in Spain.
Trial summary
AELIX-003 study aims to investigate the safety, tolerability, immunogenicity and efficacy of a regimen containing AELIX Therapeutics' HTI T-cell vaccines and Gilead´s Toll-Like Receptor 7 (TLR7) agonist vesatolimod in HIV-infected individuals on antiretroviral therapy. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- ChAdOx1.HTI, MVA.HTI and GS-9620
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 9 sitesSpain
- Study dates
- 20 Feb 2020to 16 Dec 2022
- Phase
- Phase 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Understands the study information provided and is capable of giving written informed consent, in the opinion of the investigator or designee.
- Has confirmed HIV-1 infection.
- Has received ART that was initiated within 6 months of the estimated date of HIV-1 acquisition. The ART regimen is required to have included ≥3 antiretroviral drugs at the time of treatment initiation and is required to include ≥3 antiretroviral drugs at screening, but temporary use of a 2-drug ART regimen during the time between ART initiation and the screening visit is permitted
- Has plasma HIV-1 RNA levels <50 copies/mL at the screening visit and has been virologically suppressed, defined as pVL <50 copies/mL, for at least 1 year before screening; isolated blips allowed
- Has documented stable CD4 counts ≥450 cells/mm3 for the 6 months before screening and at the screening visit.
- Has nadir CD4 count ≥200 cells/mm3 since human immunodeficiency virus (HIV) diagnosis; isolated lower counts at the moment of acute HIV-1 infection will be allowed only if appropriate immune recovery was followed after ART initiation
Show all 12Show fewer
- Is ≥18 and <61 years of age on the day of screening.
- Is willing to comply with all study procedures, including the ATI, collection of blood samples per the protocol and adherence to the ART regimen, and is available for the planned duration of the study.
- If heterosexually active female and of childbearing potential, must be using highly effective methods of contraception from 14 days before the first vaccination until 30 days after the end of the study (or 40 days after the last dose of vesatolimod, whichever is later); all female volunteers must be willing to undergo urine pregnancy testing at the time points specified in the schedules of events.
- Female participants who use hormonal contraceptive as one of their birth control methods must have used the same method for at least 3 months before the first vaccination.
- Female participants who have stopped menstruating for ≥12 months but do not have documentation of ovarian hormonal failure must have a serum follicle stimulating hormone level at screening that is within the post menopausal range as provided in the Central Laboratory Manual.
- If heterosexually active male, must use condoms or practice sexual abstinence from the screening visit until 90 days after the end of the study (or 100 days after the last dose of vesatolimod, whichever is later). Female partners of male participants must be using highly effective methods of birth control from the screening visit until 90 days after the end of the study (or 100 days after the last dose of vesatolimod, whichever is later)
Who cannot join
- Is pregnant or lactating at the screening visit or at any time during the study or is planning on becoming pregnant over the duration of the study.
- If available, has genotypic data (e.g., HIV genotype data) that demonstrate the presence of clinically significant mutations that would prevent the construction of a viable ART regimen post-treatment interruption.
- Has reported multiple periods of suboptimal adherence to ART, defined as reported episodes of at least 3 days without ART that were unrelated to participation in an ATI clinical study.
- Has a history of past ART interruptions lasting longer than 2 weeks.
- Has participated in another interventional clinical study within 30 days before screening.
- Has any acquired immune deficiency syndrome-defining disease or progression of HIV related disease within 90 days of screening visit.
Show all 33Show fewer
- Has a history of any moderate and/or severe autoimmune disease
- Has a history or clinical manifestations of any physical or psychiatric disorder that could impair the participant's ability to complete the study.
- Is taking HIV protease inhibitors (including low-dose ritonavir), cobicistat-containing regimens, elvitegravir, efavirenz, etravirine, or nevirapine. Participants on prohibited ART medications will be allowed to switch to an accepted treatment between screening and baseline.
- Is taking any other concomitant treatments non compatible with vesatolimod Participants on non-compatible medications at screening (e.g., atorvastatin, proton pump inhibitors) will be allowed to switch treatments; non compatible medications must be stopped at least 30 days prior to the first dose of vesatolimod.
- Has received approved vaccines within 2 weeks of study entry or has had a previous immunisation with any experimental immunogens within the previous 2 years.
- Will receive any vaccines within 4 weeks prior to, or 2 weeks after, any of the planned CCMM administrations or on a week when vesatolimod is administered.
- Has a history of anaphylaxis or a severe adverse reaction to vaccines.
- Has received blood products within 6 months of screening.
- Has received treatment for cancer or lymphoproliferative disease within 1 year of screening.
- Has received any other current or prior therapy within 30 days prior to the screening visit that, in the opinion of the investigators and/or the sponsor, would make the participant unsuitable for the study or influence the results of the study.
- Has current or has had recent use (within last 3 months before the screening visit) of IFN or systemic corticosteroids or other immunosuppressive agents (use of inhaled steroids for pulmonary conditions or topical steroids for localised skin conditions is permitted).
- Has abnormalities of the following laboratory tests at screening:
- Haematology
- Haemoglobin <11 g/dL (females) or 11.5 g/dL (males)
- Absolute neutrophil count ≤1000/mm3
- Absolute lymphocyte count ≤600/mm3
- Platelets ≤100,000/mm3 or ≥550,000/mm3 Clinical Chemistry
- Creatinine >1.3 × upper limit of normal (ULN)
- Aspartate aminotransferase >2.5 × ULN
- Alanine aminotransferase >2.5 × ULN
- Microbiology
- Positive hepatitis B surface antigen
- Positive for hepatitis C antibody, unless confirmed clearance of hepatitis C virus infection (spontaneous or following treatment) determined by negative serum hepatitis C virus polymerase chain reaction
- Positive serology indicating active syphilis requiring treatment;
- Is unwilling to undergo an ATI as planned during the study.
- Is not suitable for inclusion in the study based on the judgment of the investigator or sponsor.
- Current alcohol, drug, or substance abuse or history of such abuse within the 6 months prior to screening.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Spain9 sites
IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Hospital Clinic de Barcelona
Barcelona, 08036
Hospital Universitario Vall d'Hebrón
Barcelona, 08935
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Hospital La Princesa
Madrid, 28006
Hospital General Universitario Gregorio Marañón
Madrid, 28007
Hospital Universitario Ramon y Cajal
Madrid, 28034
Hospital Universitario La Paz
Madrid, 28046
About this study
Official title: A Phase IIa Randomised, Double-blind, Placebo-controlled Study of HIV-1 Vaccines MVA.HTI and ChAdOx1.HTI With TLR7 Agonist Vesatolimod (GS-9620) in Early Treated HIV-1 Infection
AELIX-003 study aims to investigate the safety, tolerability, immunogenicity and efficacy of a regimen containing AELIX Therapeutics' HTI T-cell vaccines and Gilead´s Toll-Like Receptor 7 (TLR7) agonist vesatolimod in HIV-infected individuals on antiretroviral therapy. Study that will be conducted in 57 participants who have started antiretroviral therapy during early HIV infection, enrolled at various clinical trial sites in Spain. All participants will be on antiretroviral therapy upon starting the study, with their HIV viral loads <50 copies/mL. Following exposure to the vaccine/vesatolimod, all participants, under careful monitoring, will temporarily stop their antiretroviral drugs to determine if the intervention is effective in keeping their HIV levels under control.
Read the detailed description
Study will evaluate safety of the investigational drugs ChAdOx1.HTI and MVA.HTI (referenced collectively as CCMM) with vesatolimod (also known as GS-9620) in participants with early treated HIV-1 infection.
The current study will also investigate the immunogenicity of CCMM + vesatolimod treatment and the impact of CCMM + vesatolimod treatment on viral rebound and viral control following an analytical treatment interruption (ATI) in participants with early treated HIV-1 infection.
HIVACAT T cell immunogen (HTI) is a novel T cell immunogen covering the most vulnerable regions of HIV. The encoding DNA sequence that has been inserted in various vaccine vectors, including viral and non-viral vectors Administration of the HTI immunogen is implemented through a heterologous prime-boost approach that includes 2 vaccine components. The aim of the sequential administration of the therapeutic vaccines is to achieve a so-called "functional cure," in which HIV-infected participants can control viral replication in the absence of ART. In this double blind, randomised, safety and tolerability study (AELIX-003), the HTI immunogen will be administered in a prime-boost regimen consisting of vaccinations with ChAdOx1.HTI (prime) and MVA.HTI (boost).
The treatment regimen in this study will also include a toll-like receptor 7 (TLR7) agonist, GS-9620, which is supported by a recent non clinical study where sequential administration of vaccines and a TLR7 agonist (GS-986, an analogue of vesatolimod) demonstrated efficacy in simian immunodeficiency virus (SIV)-infected rhesus monkeys on ART.
HTI is currently being tested in the Phase I, double blind, placebo controlled clinical study AELIX-002 through a heterologous prime-boost vaccination employing 3 products expressing the HTI antigen, DNA.HTI and MVA.HTI and ChAdOx.HTI. The available clinical data from AELIX-002 do not suggest a risk for serious adverse events (SAEs) from the products alone, used sequentially, or from the immunogen itself.
The study will screen HIV-1 infected participants who have initiated ART within 180 days (6 months) of the estimated date of HIV-1 acquisition and who have achieved virological suppression for at least 1 year prior entering AELIX-003. Participants who provide informed consent and meet study entry criteria will be randomised into 1 of 2 parallel treatment groups. The study will be conducted in 3 periods: Period 1 will last 48 weeks during which participants will receive blinded IMPs and will continue their ART regimen; Period 2 will last up to 24 weeks during which participants will discontinue their ART regimen; and Period 3 will last 12 weeks during which participants will be monitored following the restart of their ART.
- Conditions
- HIV/AIDS
- Being tested
- ChAdOx1.HTI, MVA.HTI, GS-9620, Placebo, Placebo Oral Tablet
- Keywords
- HIV infection, Therapeutic Vaccines, HTI, TLR7
- Medical subject headings
- Acquired Immunodeficiency Syndrome, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChAdOx1.HTIBiological
ChAdOx1.HTI at week 0 and week 12; Vaccine delivered as one 0. 5 mL IM injection
MVA.HTIBiological
MVA.HTI at week 24 and week 36; Vaccine delivered as one 0. 5 mL IM injection
GS-9620Drug
Also called Vesatolimod
GS-9620 at week 26,28,30,32,34,38,40,42,44 and 46 Unit-dose tablet, delivered as two 3-mg tablets
PlaceboBiological
Saline placebo delivered as one 0. 5 mL IM injection
Placebo Oral TabletDrug
Also called N/H
Unit-dose placebo tablet delivered as two 3-mg placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| CCMM+GS-9620 | Experimental | ChAdOx1.HTI 2 doses, MVA.HTI 2 doses, GS-9620 10 doses. Receives: Biological: ChAdOx1.HTI; Biological: MVA.HTI; Drug: GS-9620 |
| PLACEBO | Placebo comparator | ChAdOx1.HTI placebo 2 doses, MVA.HTI placebo 2 doses, GS-9620, placebo 10 doses. Receives: Biological: Placebo; Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants developing solicited Grade 3 or 4 local reactions
Proportion of participants developing solicited Grade 3 or 4 local reactions in the 7-day period following administration of IMPs during Period 1
Measured: During Period 1 (Weeks 0 to 48)
Proportion of participants developing solicited Grade 3 or 4 systemic reactions
Proportion of participants developing solicited Grade 3 or 4 systemic reactions in the 7-day period following administration of IMPs during Period 1
Measured: During Period 1 (Weeks 0 to 48)
Proportion of participants developing treatment-emergent SAEs
Proportion of participants developing treatment-emergent SAEs during Period 1
Measured: During Period 1 (Weeks 0 to 48)
Secondary outcomes (6)
Proportion of participants who achieve virologic suppression after resumption of ART
Proportion of participants who achieve virologic suppression (<50 copies/mL) after resumption of ART at Week 84
Measured: After period 1(Week 48 to week 84)
Proportion of participants developing treatment-emergent adverse events and SAEs (TEAEs)
Proportion of participants developing treatment-emergent adverse events and SAEs (TEAEs)
Measured: After period 1(Week 48 to week 84)
Proportion of participants with viral load <50 copies/mL/ <2000 copies/mL at 12 and 24 weeks after the start of ATI
Proportion of participants with viral load <50 copies/mL/ <2000 copies/mL at 12 and 24 weeks after the start of ATI
Measured: Week 48 to week 72
Proportion of participants that remain off ART at 12 and 24 weeks after the start of ATI
Proportion of participants that remain off ART at 12 and 24 weeks after the start of ATI
Measured: Week 48 to week 72
Breadth of total vaccine-induced HIV 1-specific responses
Breadth of total vaccine-induced HIV 1-specific T cell responses measured IFN-γ ELISPOT in vaccine and placebo recipients.
Measured: Period1 (week 0 to 48)
Proportion of participants with T cell responses to HTI encoded regions infection
Proportion of participants withT cell responses to HTI encoded regions
Measured: Period1 (week 0 to 48)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start20 Feb 2020
- Primary completion3 Oct 2022
- Study completion16 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double-blind, placebo-controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aelix Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Jose R Arribas Lopez, Md, PhD, Study chair, Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04364035
- Sponsor's protocol ID
- AELIX-003
- Acronym
- AELIX-003
- Status last verified
- Jul 2023
- First submitted
- 5 Mar 2020
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa Randomised, Double-blind, Placebo-controlled Study of HIV-1 Vaccines MVA.HTI and ChAdOx1.HTI With TLR7 Agonist Vesatolimod (GS-9620) in Early Treated HIV-1 Infection
- ClinicalTrials.gov ID
- NCT04364035
- Acronym / sponsor ID
- AELIX-003 / AELIX-003
- Conditions
- HIV/AIDS
- Keywords
- HIV infection, Therapeutic Vaccines, HTI, TLR7
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Aelix TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Gilead Sciences
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 3 Oct 2022 (actual)
- Study completion
- 16 Dec 2022 (actual)
- First posted
- 27 Apr 2020 (actual)
- 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.
AELIX-003 study aims to investigate the safety, tolerability, immunogenicity and efficacy of a regimen containing AELIX Therapeutics' HTI T-cell vaccines and Gilead´s Toll-Like Receptor 7 (TLR7) agonist vesatolimod in HIV-infected individuals on antiretroviral therapy. Study that will be conducted in 57 participants who have started antiretroviral therapy during early HIV infection, enrolled at various clinical trial sites in Spain. All participants will be on antiretroviral therapy upon starting the study, with their HIV viral loads <50 copies/mL. Following exposure to the vaccine/vesatolimod, all participants, under careful monitoring, will temporarily stop their antiretroviral drugs to determine if the intervention is effective in keeping their HIV levels under control.
Detailed description
Study will evaluate safety of the investigational drugs ChAdOx1.HTI and MVA.HTI (referenced collectively as CCMM) with vesatolimod (also known as GS-9620) in participants with early treated HIV-1 infection.
The current study will also investigate the immunogenicity of CCMM + vesatolimod treatment and the impact of CCMM + vesatolimod treatment on viral rebound and viral control following an analytical treatment interruption (ATI) in participants with early treated HIV-1 infection.
HIVACAT T cell immunogen (HTI) is a novel T cell immunogen covering the most vulnerable regions of HIV. The encoding DNA sequence that has been inserted in various vaccine vectors, including viral and non-viral vectors Administration of the HTI immunogen is implemented through a heterologous prime-boost approach that includes 2 vaccine components. The aim of the sequential administration of the therapeutic vaccines is to achieve a so-called "functional cure," in which HIV-infected participants can control viral replication in the absence of ART. In this double blind, randomised, safety and tolerability study (AELIX-003), the HTI immunogen will be administered in a prime-boost regimen consisting of vaccinations with ChAdOx1.HTI (prime) and MVA.HTI (boost).
The treatment regimen in this study will also include a toll-like receptor 7 (TLR7) agonist, GS-9620, which is supported by a recent non clinical study where sequential administration of vaccines and a TLR7 agonist (GS-986, an analogue of vesatolimod) demonstrated efficacy in simian immunodeficiency virus (SIV)-infected rhesus monkeys on ART.
HTI is currently being tested in the Phase I, double blind, placebo controlled clinical study AELIX-002 through a heterologous prime-boost vaccination employing 3 products expressing the HTI antigen, DNA.HTI and MVA.HTI and ChAdOx.HTI. The available clinical data from AELIX-002 do not suggest a risk for serious adverse events (SAEs) from the products alone, used sequentially, or from the immunogen itself.
The study will screen HIV-1 infected participants who have initiated ART within 180 days (6 months) of the estimated date of HIV-1 acquisition and who have achieved virological suppression for at least 1 year prior entering AELIX-003. Participants who provide informed consent and meet study entry criteria will be randomised into 1 of 2 parallel treatment groups. The study will be conducted in 3 periods: Period 1 will last 48 weeks during which participants will receive blinded IMPs and will continue their ART regimen; Period 2 will last up to 24 weeks during which participants will discontinue their ART regimen; and Period 3 will last 12 weeks during which participants will be monitored following the restart of their ART.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- double-blind, placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| CCMM+GS-9620 | Experimental | Biological: ChAdOx1.HTI, Biological: MVA.HTI, Drug: GS-9620ChAdOx1.HTI 2 doses, MVA.HTI 2 doses, GS-9620 10 doses. |
| PLACEBO | Placebo comparator | Biological: Placebo, Drug: Placebo Oral TabletChAdOx1.HTI placebo 2 doses, MVA.HTI placebo 2 doses, GS-9620, placebo 10 doses. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Understands the study information provided and is capable of giving written informed consent, in the opinion of the investigator or designee.
- Has confirmed HIV-1 infection.
- Has received ART that was initiated within 6 months of the estimated date of HIV-1 acquisition. The ART regimen is required to have included ≥3 antiretroviral drugs at the time of treatment initiation and is required to include ≥3 antiretroviral drugs at screening, but temporary use of a 2-drug ART regimen during the time between ART initiation and the screening visit is permitted
- Has plasma HIV-1 RNA levels <50 copies/mL at the screening visit and has been virologically suppressed, defined as pVL <50 copies/mL, for at least 1 year before screening; isolated blips allowed
- Has documented stable CD4 counts ≥450 cells/mm3 for the 6 months before screening and at the screening visit.
Key exclusion criteria (33 listed)
- Is pregnant or lactating at the screening visit or at any time during the study or is planning on becoming pregnant over the duration of the study.
- If available, has genotypic data (e.g., HIV genotype data) that demonstrate the presence of clinically significant mutations that would prevent the construction of a viable ART regimen post-treatment interruption.
- Has reported multiple periods of suboptimal adherence to ART, defined as reported episodes of at least 3 days without ART that were unrelated to participation in an ATI clinical study.
- Has a history of past ART interruptions lasting longer than 2 weeks.
- Has participated in another interventional clinical study within 30 days before screening.
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 |
|---|---|---|
| ChAdOx1.HTIChAdOx1.HTI at week 0 and week 12; Vaccine delivered as one 0. 5 mL IM injection | Biological | CCMM+GS-9620 |
| MVA.HTIMVA.HTI at week 24 and week 36; Vaccine delivered as one 0. 5 mL IM injection | Biological | CCMM+GS-9620 |
| GS-9620Also: VesatolimodGS-9620 at week 26,28,30,32,34,38,40,42,44 and 46 Unit-dose tablet, delivered as two 3-mg tablets | Drug | CCMM+GS-9620 |
| PlaceboSaline placebo delivered as one 0. 5 mL IM injection | Biological | PLACEBO |
| Placebo Oral TabletAlso: N/HUnit-dose placebo tablet delivered as two 3-mg placebo tablets | Drug | PLACEBO |
Primary outcome
Proportion of participants developing solicited Grade 3 or 4 local reactions
Time frame: During Period 1 (Weeks 0 to 48)
Proportion of participants developing solicited Grade 3 or 4 local reactions in the 7-day period following administration of IMPs during Period 1
Proportion of participants developing solicited Grade 3 or 4 systemic reactions
Time frame: During Period 1 (Weeks 0 to 48)
Proportion of participants developing solicited Grade 3 or 4 systemic reactions in the 7-day period following administration of IMPs during Period 1
Proportion of participants developing treatment-emergent SAEs
Time frame: During Period 1 (Weeks 0 to 48)
Proportion of participants developing treatment-emergent SAEs during Period 1
6 secondary outcomes
Proportion of participants who achieve virologic suppression after resumption of ART
Time frame: After period 1(Week 48 to week 84)
Proportion of participants developing treatment-emergent adverse events and SAEs (TEAEs)
Time frame: After period 1(Week 48 to week 84)
Proportion of participants with viral load <50 copies/mL/ <2000 copies/mL at 12 and 24 weeks after the start of ATI
Time frame: Week 48 to week 72
Proportion of participants that remain off ART at 12 and 24 weeks after the start of ATI
Time frame: Week 48 to week 72
Breadth of total vaccine-induced HIV 1-specific responses
Time frame: Period1 (week 0 to 48)
Proportion of participants with T cell responses to HTI encoded regions infection
Time frame: Period1 (week 0 to 48)
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 27 Jul 2023.
Related trials for HIV/AIDS
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
Jose R Arribas Lopez, Md, PhD study chair
Hospital Universitario La Paz
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ChAdOx1.HTI, MVA.HTI and GS-9620 in people with HIV/AIDS, run by Aelix Therapeutics at 9 sites in Spain.
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 12 inclusion and 33 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 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Spain. 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 phase mean?
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?
Proportion of participants developing solicited Grade 3 or 4 local reactions (time frame: During Period 1 (Weeks 0 to 48)). The study lists 3 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 27 Jul 2023.