Status:
COMPLETED
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)
Lead Sponsor:
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Collaborating Sponsors:
Aelix Therapeutics
Conditions:
HIV-1 Infection
Eligibility:
All Genders
18-40 years
Phase:
PHASE1
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...
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...
Eligibility Criteria
Inclusion
- 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.
- 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.
Exclusion
- 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).
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 10 2022
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04385875
Start Date
June 1 2020
End Date
February 10 2022
Last Update
May 4 2022
Active Locations (1)
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1
Germans Trias i Pujol Hospital
Badalona, Barcelona, Spain, 08916