A Study of the Safety and Antiretroviral Activity of 3BNC117
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|ClinicalTrials.gov Identifier: NCT02588586|
Recruitment Status : Completed
First Posted : October 28, 2015
Last Update Posted : April 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|HIV-1 Infection||Drug: 3BNC117 Other: Antiretroviral Treatment Interruption||Phase 2|
The proposed study is a Phase II, open label study to evaluate the safety, antiretroviral activity and pharmacokinetics of four infusions of 3BNC117 in HIV-infected individuals on combination ART and during a brief analytical treatment interruption (ATI).
Study participants will be administered four intravenous infusions of 3BNC117, administered at 30 mg/kg on day 0, week 12, week 24 and week 27. Antiretroviral therapy will be discontinued 2 days after the third 3BNC117 infusion (week 24), until week 36.
The ART regimen will be resumed at week 36 or sooner if plasma HIV-1 RNA level is ≥ 200 copies/ml, CD4+ T cell count drops < 350 cells/microliter, and results are confirmed upon repeat measurement during the next weekly scheduled visit. If plasma HIV-1 RNA level is ≥ 1,000 copies/ml, the participant will be asked to return for a repeat measurement prior to the next scheduled visit, and ART will be resumed if results are confirmed. ART will also be resumed early if the participant becomes pregnant or if otherwise clinically indicated. If ART is resumed before week 27, the fourth 3BNC117 infusion will not be administered.
Participants will be followed weekly during the analytical treatment interruption phase for safety assessments and for monitoring plasma HIV-1 RNA levels. CD4+ T cell counts will be monitored every 2 weeks during the analytical treatment interruption phase.
Participants may remain off antiretroviral therapy after week 36, with weekly viral load monitoring, if viral rebound does not occur by week 36.
All participants will be followed for a total of 60 weeks from enrollment.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label, Phase 2 Study of the Safety and Antiretroviral Activity of 3BNC117 in HIV-Infected Individuals on Combination Antiretroviral Therapy|
|Study Start Date :||October 2015|
|Actual Primary Completion Date :||February 2018|
|Actual Study Completion Date :||April 2018|
Experimental: 3BNC117 + ART Interruption
Four intravenous infusions of 3BNC117 (30mg/kg) at weeks 0, 12, 24 and 27, and antiretroviral treatment interruption (ART)at week 24.
Other Name: 3BNC117 antibody
Other: Antiretroviral Treatment Interruption
Antiretroviral therapy will be discontinued 2 days after the third 3BNC117 infusion, at week 24, and resumed at week 36.
Other Name: Treatment Interruption
- Rate of viral rebound at 12 weeks after interruption of antiretroviral therapy [ Time Frame: 12 weeks ]Viral rebound is defined as confirmed plasma HIV-1 RNA level > 200 copies/ml in two separate occasions
- Serum level of 3BNC117 at the time of viral rebound, measured in micrograms per ml [ Time Frame: 12 weeks ]Serum level of 3BNC117 at the time of viral rebound, measured in micrograms per ml
- Time to viral rebound after interruption of antiretroviral therapy [ Time Frame: 12 weeks ]Viral rebound is defined as confirmed plasma HIV-1 RNA level > 200 copies/ml in two separate occasions
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 60 weeks ]Number of Participants with Adverse Events as a Measure of Safety and Tolerability
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02588586
|United States, New York|
|The Rockefeller University|
|New York, New York, United States, 10065|
|Weill Cornel Medical Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Marina Caskey, MD||The Rockefeller University|