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)

PHASE1CompletedINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

June 1, 2020

Primary Completion Date

August 30, 2021

Study Completion Date

February 10, 2022

Conditions
HIV-1 Infection
Interventions
BIOLOGICAL

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.

OTHER

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.

Trial Locations (1)

08916

Germans Trias i Pujol Hospital, Badalona

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Aelix Therapeutics

INDUSTRY

lead

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

OTHER

NCT04385875 - 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) | Biotech Hunter | Biotech Hunter