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)

NCT ID: NCT04385875

Last Updated: 2022-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2022-02-10

Brief 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. 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.

Conditions

HIV-1 Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Vaccine group

ATI\_extension will keep allocation from AELIX-002 for a separate description of the results.

Group Type: EXPERIMENTAL

Vaccine + extension of the ATI period

Intervention Type: BIOLOGICAL

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 group

ATI\_extension will keep allocation from AELIX-002 for a separate description of the results.

Group Type: PLACEBO_COMPARATOR

Placebo + extension of the ATI period

Intervention Type: OTHER

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.

Interventions

Vaccine + extension of the ATI period

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.

Intervention Type: BIOLOGICAL

Placebo + extension of the ATI period

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Participants of the AELIX-002 clinical trial at week 24 of ATI:

1. Willing to continue the ATI up to 1 year.

2. With pVL <2,000 copies/ml at week 24 of ATI on the AELIX-002 study.

3. CD4 count ≥350 cells/mm3 at week 24 of ATI on the AELIX-002study.

4. Willing to comply with the measures to prevent HIV transmission and reinfection required by the protocol.

5. Available for follow-up for the planned duration of the ATI period of this study.

6. Willing to accept blood draws and collect stool at time points specified in the Schedule of Procedures.

7. 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.

8. 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.

9. Not willing to donate blood during the study.

10. Participants who understand the information provided, in the opinion of the investigator.

Exclusion Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aelix Therapeutics

INDUSTRY

Sponsor Role: collaborator

Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Germans Trias i Pujol Hospital

Badalona, Barcelona, Spain

Countries

Spain

Other Identifiers

ATI_extension

Identifier Type: -

Identifier Source: org_study_id