Phase 2
N=16
3BNC117 Monoclonal Antibody in HIV-infected Subjects During Treatment Interruption
HIV-1 Infection
Bottom Line
View on ClinicalTrials.gov: NCT02446847 ↗Enrolled (actual)
16
Serious AEs
6.3%
Results posted
Jul 2020
Primary outcome: Primary: Number of Participants With Virologic Rebound at 8 Weeks After Interruption of Antiretroviral Therapy — 4; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 3BNC117 (Drug); ART Interruption (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rockefeller University
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Virologic Rebound at 8 Weeks After Interruption of Antiretroviral Therapy |
4; 3 | — |
| PRIMARY The Rate of Signs, Symptoms and Laboratory Abnormalities After 3BNC117 Infusions |
8; 8 | — |
| SECONDARY The Plasma Level of 3BNC117 at the Time of Viral Rebound. |
61.15; 74.37 | — |
Summary
This study evaluates the effects of two infusions of 3BNC117 in preventing or delaying rebound of viral load during a brief treatment interruption of standard ART and its safety during a brief analytical interruption of antiretroviral therapy.
Eligibility Criteria
Inclusion Criteria
- Age 18 to 65
- HIV-1 infection confirmed by ELISA and immunoblot.
- Plasma HIV-1 RNA 500 cells/μl and no prior CD4 cell count 180 and/or diastolic blood pressure > 120, in the presence or absence of anti-hypertensive medications;
- Any other clinically significant acute or chronic medical condition, such as autoimmune diseases, that in the opinion of the investigator would preclude participation;
- Current cigarette use in excess of 1 pack per day;
- Laboratory abnormalities in the parameters listed below:
- Absolute neutrophil count ≤1,000
- Hemoglobin ≤ 10 gm/dL
- Platelet count ≤125,000
- ALT ≥ 2.0 x ULN
- AST ≥ 2.0 x ULN
- Total bilirubin ≥ 1.5 ULN
- Creatinine ≥ 1.1 x ULN
- Coagulation parameters ≥ 1.5 x ULN;
- Current antiretroviral regimen includes either maraviroc or enfuvirtide;
- Pregnancy or lactation;
- Any vaccination within 14 days prior to 3BNC117 administration;
- Receipt of any monoclonal antibody therapy of any kind in the past;
- Participation in another clinical study of an investigational product currently or within past 12 weeks, or expected participation during this study.
- History of resistance to two or more antiretroviral drug classes
Data sourced from ClinicalTrials.gov (NCT02446847). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.