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

Immune Therapy and Analytical Treatment Interruption in HIV+ participants who received an allogeneic stem cell transplantation (ITATI)

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-001461-32-ES

Enrollment

Unknown

Registered

2019-10-29

Start date

2019-10-25

Completion date

Unknown

Last updated

2019-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV+ infected subjects with undetectable replication competent HIV reservoir after allogeneic stem cell transplantation in presence of cART. MedDRA version: 20.1 Level: PT Classification code 10020161 Term: HIV infection System Organ Class: 10021881 - Infections and infestations

Interventions

Product Code: bNAb 3BNC117 Pharmaceutical Form: Infusion INN or Proposed INN: 3BNC117 Current Sponsor code: 3BNC117 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentr

Eligibility

Sex/Gender

All

Inclusion criteria

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 (=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the effects of eight intravenous infusions of 3BNC117 and 10-1074, each dosed at 30 mg/kg, on maintaining viral suppression under cART discontinuation in HIV+ participants with undetectable replication competent HIV reservoir after allogeneic stem cell transplantation in presence of cART.;Secondary Objective: - To evaluate the safety and tolerability of eight intravenous infusions of 3BNC117 and 10-1074, each dosed at 30 mg/kg, in HIV-infected individuals during first 8 months of ATI. - To determine the serum levels of 3BNC117 and 10-1074 throughout the study.;Primary end point(s): - Time to reappearance of HIV-1 viremia (plasma HIV-1 RNA level > 50 copies/ml in 2 consecutive measurements) after ART interruption. - Time to reappearance of HIV-1 replication competent reservoir (determined by the number of infectious units per 10^6 CD4+ T cells (IUPM) using a viral outgrowth assay) after ART interruption. - Time to reappearance of HIV-1 total reservoir (determined by the number HIV-DNA copies per 10^6 CD4+ T cells) after ART interruption.;Timepoint(s) of evaluation of this end point: The viral load is measured since the baseline to the end of the study, every 2 weeks. HIV-1 reservoir is measured since the baseline to the end of the study, every month.	—

Measure

Time frame

Main Objective: To evaluate the effects of eight intravenous infusions of 3BNC117 and 10-1074, each dosed at 30 mg/kg, on maintaining viral suppression under cART discontinuation in HIV+ participants with undetectable replication competent HIV reservoir after allogeneic stem cell transplantation in presence of cART.;Secondary Objective: - To evaluate the safety and tolerability of eight intravenous infusions of 3BNC117 and 10-1074, each dosed at 30 mg/kg, in HIV-infected individuals during first 8 months of ATI. - To determine the serum levels of 3BNC117 and 10-1074 throughout the study.;Primary end point(s): - Time to reappearance of HIV-1 viremia (plasma HIV-1 RNA level > 50 copies/ml in 2 consecutive measurements) after ART interruption. - Time to reappearance of HIV-1 replication competent reservoir (determined by the number of infectious units per 10^6 CD4+ T cells (IUPM) using a viral outgrowth assay) after ART interruption. - Time to reappearance of HIV-1 total reservoir (determined by the number HIV-DNA copies per 10^6 CD4+ T cells) after ART interruption.;Timepoint(s) of evaluation of this end point: The viral load is measured since the baseline to the end of the study, every 2 weeks. HIV-1 reservoir is measured since the baseline to the end of the study, every month.

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Secondary

Measure	Time frame
Secondary end point(s): - Safety evaluation, as measured by rate and severity of adverse events (AE) and serious adverse events (SAE). - Serum levels of 3BNC117 and 10-1074 throughout the study.;Timepoint(s) of evaluation of this end point: As well as ad hoc reporting, safety and Serum levels of 3BNC117 and 10-1074 will be assessed at the following visits: - bNAbs administration visits: M1, M2, M3, M4, M5, M6, M7 AND M8. - Follow-up visits: M9, M10, M11, M12, M13, M14, M15, M16, M17. - End of study visit: M18	—

Measure

Time frame

Secondary end point(s): - Safety evaluation, as measured by rate and severity of adverse events (AE) and serious adverse events (SAE). - Serum levels of 3BNC117 and 10-1074 throughout the study.;Timepoint(s) of evaluation of this end point: As well as ad hoc reporting, safety and Serum levels of 3BNC117 and 10-1074 will be assessed at the following visits: - bNAbs administration visits: M1, M2, M3, M4, M5, M6, M7 AND M8. - Follow-up visits: M9, M10, M11, M12, M13, M14, M15, M16, M17. - End of study visit: M18

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Countries

Spain

Contacts

Public ContactProject Manager

FLS-Research Support

jtoro@fls-rs.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026