Stopping treatment along with immune therapy in patients with HIV + who have already been treated with stem cells from each blood cells are formed

Phase 1

• Conditions: HIV+ infected subjects with undetectable replication competent HIV reservoir after allogeneic stem cell transplantation in presence of cART.; MedDRA version: 20.1Level: PTClassification code 10020161Term: HIV infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2019-001461-32-ES
• Lead Sponsor: IrsiCaixa AIDS Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-29
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 0

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified