EUCTR2019-001461-32-ESActive, not recruitingPhase 1
Immune Therapy and Analytical Treatment Interruption in HIV+ participants who received an allogeneic stem cell transplantation (ITATI)
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. More than 2 years post-HSCT
- •2. Being off immunosuppression for at least one year (related to allo-HSCT)
- •3. Undetectable levels of HIV replication competent reservoirs in blood (< 0,1 IUPM)
- •4. CD4 count levels higher than 200 cel/mm3.
- •5. Aged at least 18 years and not older than 65 at the day of screening
- •6. Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study.
- •7. In the opinion of the principal investigator or designee, the participant has understood the information provided and capable of giving written informed consent.
- •8. 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.
- •9. 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.
- •10. Willing to accept blood draws at time points specified.
- •11. Not sharing injection drug equipment, such as needles.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 5
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •1. Pregnancy or lactating
- •2. Participation in another clinical trial within 12 weeks of study entry (at screening period).
- •3. History or clinical manifestations of any physical or psychiatric disorder which could impair the subject’s ability to complete the study.
Investigators
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