HIV-1 InfectionPhase 1NCT04385875
Study to Assess the Safety and Durability of Viral Control Beyond 24 Weeks of Analytical Treatment Interruption After the Administration of Candidate HIV-1 Vaccines DNA.HTI, MVA.HTI and ChAdOx1.HTI or Placebo in Early Treated HIV-1 Positive Individuals (ATI Extension of AELIX-002 Study)
A Phase 1 study testing Vaccine + extension of the ATI period in people with HIV-1 Infection, run by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia at 1 site in Spain.
Trial summary
The AELIX-002 trial has been conducted on a cohort of individuals who started cART within the first 6 months after the primary VIH infection, thus increasing the likelihood of observing a certain rate of post-treatment controls (PTC), regardless of treatment efficacy. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- HIV-1 Infection
- What is being tested?
- Vaccine + extension of the ATI period
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2020to 10 Feb 2022
- Phase
- Phase 1
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants of the AELIX-002 clinical trial at week 24 of ATI:
- Willing to continue the ATI up to 1 year.
- With pVL <2,000 copies/ml at week 24 of ATI on the AELIX-002 study.
- CD4 count ≥350 cells/mm3 at week 24 of ATI on the AELIX-002study.
- Willing to comply with the measures to prevent HIV transmission and reinfection required by the protocol.
- Available for follow-up for the planned duration of the ATI period of this study.
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- Willing to accept blood draws and collect stool at time points specified in the Schedule of Procedures.
- If heterosexually active female; using an effective method of contraception (hormonal contraception, intra-uterine device
- (IUD), or anatomical sterility in self or partner1) during the ATI and until her pVL is <50 copies/ml after cART resumption.
- If heterosexually active male; using an effective method of contraception (anatomical sterility in self) or agree on the use of an effective method of contraception by his partner (hormonal contraception, intra-uterine device (IUD), or anatomical
- sterility1) during the ATI and until his pVL is <50 copies/ml after cART resumption.
- Not willing to donate blood during the study.
- Participants who understand the information provided, in the opinion of the investigator.
Who cannot join
- 1- Pregnancy or breastfeeding.
- 2. History or clinical manifestations of any physical or psychiatric disorder which could impair the subject's ability to complete the study.
- 3. Any other current or prior therapy which, in the opinion of the investigators, would make the individual unsuitable for the study or influence the results of the study.
- 4. Active hepatitis B or C at week 24 of ATI on the AELIX-002 study.
- 5. Risk of HIV transmission (i.e. repeated STI during the AELIX-002 ATI period or reported unprotected anal sex).
Trial locations and contacts
1 site in 1 country.
About this study
The AELIX-002 trial has been conducted on a cohort of individuals who started cART within the first 6 months after the primary VIH infection, thus increasing the likelihood of observing a certain rate of post-treatment controls (PTC), regardless of treatment efficacy. Although the kinetics of HIV rebound should allow observing differences between placebo and control regarding the post treatment controls rate in case of efficacy of the IMPs, assessing the length and determinants of a post-intervention control (PIC) (i.e., associated with vaccination) beyond 24 weeks is crucial for developing a curative approach to HIV infection. In this regard, an extension of the ATI phase for those individuals with pVL less than 2,000 copies/mL after 24 weeks of ATI in the AELIX-002 offers an unique research opportunity to better understand relevant aspects of the mechanisms involved in the different phenotypes of a PIC and PTC.
Read the detailed description
The AELIX-002 trial has been conducted on a cohort of individuals who started cART within the first 6 months after the primary VIH infection, thus increasing the likelihood of observing a certain rate of post-treatment controls (PTC), regardless of treatment efficacy. Although the kinetics of HIV rebound should allow observing differences between placebo and control regarding the post treatment controls rate in case of efficacy of the IMPs, assessing the length and determinants of a post-intervention control (PIC) (i.e., associated with vaccination) beyond 24 weeks is crucial for developing a curative approach to HIV infection. In this regard, an extension of the ATI phase for those individuals with pVL less than 2,000 copies/mL after 24 weeks of ATI in the AELIX-002 offers an unique research opportunity to better understand relevant aspects of the mechanisms involved in the different phenotypes of a PIC and PTC.
This trial will enrol participants of the AELIX-002 clinical trial regardless of whether they received vaccines or placebo, who reach 24 weeks of ATI with pVL <2,000 cop/ml and are willing to remain off cART. After accepting participation, subjects will undergo a one-year extension [48 weeks] of ATI monitoring (total duration of ATI envisioned will be of 72 weeks [24 weeks in AELIX-002 study + 48 weeks in current study]), followed by 24 weeks of safety follow-up after cART is resumed.
The primary objective of this study is to assess the safety and durability of viral control after AELIX-002 clinical trial intervention beyond 6 months of ATI. Furthermore, the study will collect biological samples to be stored for further investigational studies.
- Conditions
- HIV-1 Infection
- Being tested
- Vaccine + extension of the ATI period, Placebo + extension of the ATI period
- Keywords
- HIV-1 infection, Therapeutic Vaccines, HTI, Antiretroviral Treatment Interruption (ATI), Viral control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccine + extension of the ATI periodBiological
During the AELIX-002 trial participants received the following: DNA.HTI at weeks 0, 4, and 8 and MVA.HTI at weeks 12 and 20 (DDDMM) followed by ChAdOx1.HTI at weeks 0 and 12 and MVA.HTI at week 24 (CCM), starting at least 24 weeks after MVA.HTI week 20. After that, on ATI_extension trial, ATI will be extended for 48 weeks.
Placebo + extension of the ATI periodOther
During the AELIX-002 trial participants received the following: Normal saline solution at weeks 0, 4, 8, 12, and 20 (PPPPP) followed by normal saline solution at weeks 0, 12 and 24 (PPP), starting at least 24 weeks after week 20 administration. After that, on ATI_extension trial, ATI will be extended for 48 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Vaccine group | Experimental | ATI_extension will keep allocation from AELIX-002 for a separate description of the results. Receives: Biological: Vaccine + extension of the ATI period |
| Placebo group | Placebo comparator | ATI_extension will keep allocation from AELIX-002 for a separate description of the results. Receives: Other: Placebo + extension of the ATI period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with viral remission
Percentage of participants with viral remission, defined as plasma viral load (pVL) <50 copies/ml at 72 weeks after start of ATI.
Measured: week 72
Percentage of participants with viral control
Percentage of participants with viral control, defined as a pVL <2,000 copies/ml at 72?weeks after start of ATI.
Measured: week 72
Time to viral detection
Time to viral detection up to 72 weeks after start of ATI, defined as the time from ATI start to first occurrence of detectable pVL (≥50 copies/ml).
Measured: up to 72weeks after start of ATI
Time to viral rebound
Time to viral rebound up to 72 weeks after start of ATI, defined as the time from ATI start to first occurrence of ≥ 2,000 copies/ml.
Measured: up to 72 weeks after start of ATI
Percentage of participants who remain off cART
Percentage of participants who remain off cART at 72 weeks after ATI start.
Measured: Week 72
Time off cART
Time off cART, defined as time to cART resumption from ATI start.
Measured: From ATI start to week 72
Secondary outcomes (6)
Phenotypes characterization
Different phenotypes will be characterized by the description of pVL and CD4 dynamics of each participant, and grouping according to their profile (non-rebounders, late-rebounders, post-rebound controllers, …).
Measured: From ATI start to week 72
Change in a score for ATI psychological impact
Acceptability and the psychological impact of a longer ATI will be assessed by the change in a score of a questionnaire administered at weeks 24, 48 and at week 4 post cART resumption (or at the End of ATI visit in case of early withdrawal).
Measured: At weeks 24, 48 and at week 4 post cART resumption (or at the End of ATI visit in case of early withdrawal).
The proportion of participants who develop symptoms compatible with acute retroviral syndrome.
The proportion of participants who develop symptoms compatible with acute retroviral syndrome.
Measured: From ATI start to week 72
The proportion of participants who suppress pVL to <50 copies/ml
The proportion of participants who suppress pVL to <50 copies/ml 24 weeks after cART resumption
Measured: 24 weeks after cART resumption
The proportion of participants who develop new mutations not present in the pre-cART genotype
The proportion of participants who develop new mutations not present in the pre-cART genotype conferring clinically-significant resistance to antiretroviral drugs (out of the individuals not reaching viral re-suppression 24 weeks after cART resumption).
Measured: 24 weeks after cART resumption
Description of participants who develop AEs related to the prime- boost regimen during this extension of ATI period.
Description of participants who develop AEs related to the prime-boost regimen during this extension of ATI period.
Measured: From ATI_extension start to week 72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start1 Jun 2020
- Primary completion30 Aug 2021
- Study completion10 Feb 2022
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.
- 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants of the AELIX-002 clinical trial were randomly allocated to one of the following arms: * Vaccine: DNA.HTI at weeks 0, 4, and 8 and MVA.HTI at weeks 12 and 20 (DDDMM) followed by ChAdOx1.HTI at weeks 0 and 12 and MVA.HTI at week 24 (CCM), starting at least 24 weeks after MVA.HTI week 20. * Placebo: Normal saline solution at weeks 0, 4, 8, 12, and 20 (PPPPP) followed by normal saline solution at weeks 0, 12 and 24 (PPP), starting at least 24 weeks after week 20 administration. ATI\_extension will keep allocation from AELIX-002 for a separate description of the results.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
- Sponsor type
- University, hospital or other
- Collaborators
- Aelix Therapeutics
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04385875
- Sponsor's protocol ID
- ATI_extension
- Status last verified
- May 2022
- First submitted
- 8 May 2020
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Assess the Safety and Durability of Viral Control Beyond 24 Weeks of Analytical Treatment Interruption After the Administration of Candidate HIV-1 Vaccines DNA.HTI, MVA.HTI and ChAdOx1.HTI or Placebo in Early Treated HIV-1 Positive Individuals (ATI Extension of AELIX-002 Study)
- ClinicalTrials.gov ID
- NCT04385875
- Acronym / sponsor ID
- ATI_extension
- Conditions
- HIV-1 Infection
- Keywords
- HIV-1 infection, Therapeutic Vaccines, HTI, Antiretroviral Treatment Interruption (ATI), Viral control
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la CienciaUniversity, hospital or other
- Collaborators
- Aelix Therapeutics
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 10 Feb 2022 (actual)
- First posted
- 13 May 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.
The AELIX-002 trial has been conducted on a cohort of individuals who started cART within the first 6 months after the primary VIH infection, thus increasing the likelihood of observing a certain rate of post-treatment controls (PTC), regardless of treatment efficacy. Although the kinetics of HIV rebound should allow observing differences between placebo and control regarding the post treatment controls rate in case of efficacy of the IMPs, assessing the length and determinants of a post-intervention control (PIC) (i.e., associated with vaccination) beyond 24 weeks is crucial for developing a curative approach to HIV infection. In this regard, an extension of the ATI phase for those individuals with pVL less than 2,000 copies/mL after 24 weeks of ATI in the AELIX-002 offers an unique research opportunity to better understand relevant aspects of the mechanisms involved in the different phenotypes of a PIC and PTC.
Detailed description
The AELIX-002 trial has been conducted on a cohort of individuals who started cART within the first 6 months after the primary VIH infection, thus increasing the likelihood of observing a certain rate of post-treatment controls (PTC), regardless of treatment efficacy. Although the kinetics of HIV rebound should allow observing differences between placebo and control regarding the post treatment controls rate in case of efficacy of the IMPs, assessing the length and determinants of a post-intervention control (PIC) (i.e., associated with vaccination) beyond 24 weeks is crucial for developing a curative approach to HIV infection. In this regard, an extension of the ATI phase for those individuals with pVL less than 2,000 copies/mL after 24 weeks of ATI in the AELIX-002 offers an unique research opportunity to better understand relevant aspects of the mechanisms involved in the different phenotypes of a PIC and PTC.
This trial will enrol participants of the AELIX-002 clinical trial regardless of whether they received vaccines or placebo, who reach 24 weeks of ATI with pVL <2,000 cop/ml and are willing to remain off cART. After accepting participation, subjects will undergo a one-year extension [48 weeks] of ATI monitoring (total duration of ATI envisioned will be of 72 weeks [24 weeks in AELIX-002 study + 48 weeks in current study]), followed by 24 weeks of safety follow-up after cART is resumed.
The primary objective of this study is to assess the safety and durability of viral control after AELIX-002 clinical trial intervention beyond 6 months of ATI. Furthermore, the study will collect biological samples to be stored for further investigational studies.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants of the AELIX-002 clinical trial were randomly allocated to one of the following arms: * Vaccine: DNA.HTI at weeks 0, 4, and 8 and MVA.HTI at weeks 12 and 20 (DDDMM) followed by ChAdOx1.HTI at weeks 0 and 12 and MVA.HTI at week 24 (CCM), starting at least 24 weeks after MVA.HTI week 20. * Placebo: Normal saline solution at weeks 0, 4, 8, 12, and 20 (PPPPP) followed by normal saline solution at weeks 0, 12 and 24 (PPP), starting at least 24 weeks after week 20 administration. ATI_extension will keep allocation from AELIX-002 for a separate description of the results.
| Arm | Type | Receives |
|---|---|---|
| Vaccine group | Experimental | Biological: Vaccine + extension of the ATI periodATI_extension will keep allocation from AELIX-002 for a separate description of the results. |
| Placebo group | Placebo comparator | Other: Placebo + extension of the ATI periodATI_extension will keep allocation from AELIX-002 for a separate description of the results. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Participants of the AELIX-002 clinical trial at week 24 of ATI:
- (IUD), or anatomical sterility in self or partner1) during the ATI and until her pVL is <50 copies/ml after cART resumption.
- sterility1) during the ATI and until his pVL is <50 copies/ml after cART resumption.
Key exclusion criteria (5 listed)
- 1- Pregnancy or breastfeeding.
- 2. History or clinical manifestations of any physical or psychiatric disorder which could impair the subject's ability to complete the study.
- 3. Any other current or prior therapy which, in the opinion of the investigators, would make the individual unsuitable for the study or influence the results of the study.
- 4. Active hepatitis B or C at week 24 of ATI on the AELIX-002 study.
- 5. Risk of HIV transmission (i.e. repeated STI during the AELIX-002 ATI period or reported unprotected anal sex).
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 |
|---|---|---|
| Vaccine + extension of the ATI periodDuring the AELIX-002 trial participants received the following: DNA.HTI at weeks 0, 4, and 8 and MVA.HTI at weeks 12 and 20 (DDDMM) followed by ChAdOx1.HTI at weeks 0 and 12 and MVA.HTI at week 24 (CCM), starting at least 24 weeks after MVA.HTI week 20. After that, on ATI_extension trial, ATI will be extended for 48 weeks. | Biological | Vaccine group |
| Placebo + extension of the ATI periodDuring the AELIX-002 trial participants received the following: Normal saline solution at weeks 0, 4, 8, 12, and 20 (PPPPP) followed by normal saline solution at weeks 0, 12 and 24 (PPP), starting at least 24 weeks after week 20 administration. After that, on ATI_extension trial, ATI will be extended for 48 weeks. | Other | Placebo group |
Primary outcome
Percentage of participants with viral remission
Time frame: week 72
Percentage of participants with viral remission, defined as plasma viral load (pVL) <50 copies/ml at 72 weeks after start of ATI.
Percentage of participants with viral control
Time frame: week 72
Percentage of participants with viral control, defined as a pVL <2,000 copies/ml at 72?weeks after start of ATI.
Time to viral detection
Time frame: up to 72weeks after start of ATI
Time to viral detection up to 72 weeks after start of ATI, defined as the time from ATI start to first occurrence of detectable pVL (≥50 copies/ml).
Time to viral rebound
Time frame: up to 72 weeks after start of ATI
Time to viral rebound up to 72 weeks after start of ATI, defined as the time from ATI start to first occurrence of ≥ 2,000 copies/ml.
Percentage of participants who remain off cART
Time frame: Week 72
Percentage of participants who remain off cART at 72 weeks after ATI start.
Time off cART
Time frame: From ATI start to week 72
Time off cART, defined as time to cART resumption from ATI start.
6 secondary outcomes
Phenotypes characterization
Time frame: From ATI start to week 72
Change in a score for ATI psychological impact
Time frame: At weeks 24, 48 and at week 4 post cART resumption (or at the End of ATI visit in case of early withdrawal).
The proportion of participants who develop symptoms compatible with acute retroviral syndrome.
Time frame: From ATI start to week 72
The proportion of participants who suppress pVL to <50 copies/ml
Time frame: 24 weeks after cART resumption
The proportion of participants who develop new mutations not present in the pre-cART genotype
Time frame: 24 weeks after cART resumption
Description of participants who develop AEs related to the prime- boost regimen during this extension of ATI period.
Time frame: From ATI_extension start to week 72
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 4 May 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vaccine + extension of the ATI period in people with HIV-1 Infection, run by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia at 1 site 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 13 inclusion and 5 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 4 May 2022. 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 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 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.
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?
Percentage of participants with viral remission (time frame: week 72). The study lists 6 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 4 May 2022.