Status:
WITHDRAWN
Immune Therapy and Analytical Treatment Interruption in HIV+ Participants Who Received an Allogeneic Stem Cell Transplantation
Lead Sponsor:
IrsiCaixa
Conditions:
HIV Infection
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The availability of antiretroviral therapy (cART) for HIV-1 infection has led to a reduction in morbidity in patients with chronic HIV infection. However, cART does not eliminate HIV-1 that persists a...
Detailed Description
The availability of antiretroviral therapy (cART) for HIV-1 infection has led to a reduction in morbidity in patients with chronic HIV infection. However, cART does not eliminate HIV-1 that persists a...
Eligibility Criteria
Inclusion
- More than 2 years post-HSCT
- Being off immunosuppression for at least one year (related to allo-HSCT)
- Undetectable levels of HIV replication competent reservoirs in blood (\< 0,1 IUPM).
- CD4 count levels higher than 200 cel/mm3.
- Aged at least 18 years and not older than 65 at the day of screening
- Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study.
- In the opinion of the principal investigator or designee, the participant has understood the information provided and capable of giving written informed consent.
- If heterosexually active female; using an effective method of contraception (hormonal contraception, intra-uterine device (IUD), or anatomical sterility in self or partner1) from 14 days prior to the first bNAbs administration until at least 6 months after the last bNAbs administration; all female volunteers must be willing to undergo urine pregnancy tests at time points specified.
- If heterosexually active male; willing to use 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 from the day of the first bNAbs administration until 6 months after the last bNAbs administration.
- Willing to accept blood draws at time points specified.
- Not sharing injection drug equipment, such as needles.
- Condom use nor diaphragm are considered as an additional method of contraception only and cannot be the only method of contraception used as not been considered an effective method by the Clinical Trial Facilitation Group (CTFG) guidelines.
Exclusion
- Pregnancy or lactating
- Participation in another clinical trial within 12 weeks of study entry (at screening period).
- History or clinical manifestations of any physical or psychiatric disorder which could impair the subject's ability to complete the study.
Key Trial Info
Start Date :
February 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 28 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04720742
Start Date
February 28 2021
End Date
March 28 2022
Last Update
August 3 2022
Active Locations (4)
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1
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
Milan, Lombardy, Italy, 20122
2
University Medical Center Utrecht
Utrecht, Netherlands, 3584
3
Complejo Hospitalario Universitario de Granada
Granada, Andalusia, Spain, 18014
4
Hospital Gregorio Marañón
Madrid, Spain, 28009