NCT02511990

Brief Summary

This is a phase 1 clinical trial to evaluate the safety, pharmacokinetics and the antiretroviral effects of the highly neutralizing anti-HIV-1 monoclonal antibody 10-1074 in HIV-infected and HIV-uninfected individuals.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jul 2015

Longer than P75 for phase_1 healthy

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

July 24, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 30, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

February 5, 2018

Status Verified

January 1, 2018

Enrollment Period

1.4 years

First QC Date

July 24, 2015

Last Update Submit

January 31, 2018

Conditions

HealthyHIV

Keywords

HIV10-1074Monoclonal Antibody

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    24 weeks after 10-1074 administration

Secondary Outcomes (3)

  • Serum peak concentration of 10-1074, measured in micrograms per ml

    24 hours after 10-1074 administration

  • Serum half-life of 10-1074 expressed in days

    24 Weeks after 10-1074 administration

  • Plasma HIV-1 RNA levels measured in copies/ml

    2 weeks after 10-1074 administration

Study Arms (8)

Group 1A

EXPERIMENTAL

HIV-infected individuals Off ART, HIV-1 viral load \< 100,000 copies/ml or On ART, HIV-1 viral load \< 500 copies/ml 3 mg/kg, single dose IV administration of 10-1074

Biological: 3 mg/kg, single dose IV administration of 10-1074

Group 1B

EXPERIMENTAL

HIV-infected individuals Off ART, HIV-1 viral load \< 100,000 copies/ml or On ART, HIV-1 viral load \< 500 copies/ml 10 mg/kg, single dose IV administration of 10-1074

Biological: 10 mg/kg, single dose IV administration of 10-1074

Group 1C

EXPERIMENTAL

HIV-infected individuals Off ART, HIV-1 viral load \< 100,000 copies/ml or On ART, HIV-1 viral load \< 500 copies/ml 30 mg/kg, single dose IV administration of 10-1074

Biological: 30 mg/kg, single dose IV administration of 10-1074

Group 1D

EXPERIMENTAL

HIV-infected individuals Off ART, HIV-1 viral load \< 100,000 copies/ml 30 mg/kg, single dose IV administration of 10-1074

Biological: 30 mg/kg, single dose IV administration of 10-1074

Group 2A

EXPERIMENTAL

HIV-uninfected individuals 3 mg/kg, single dose IV administration of 10-1074

Biological: 3 mg/kg, single dose IV administration of 10-1074

Group 2B

EXPERIMENTAL

HIV-uninfected individuals 10 mg/kg, single dose IV administration of 10-1074

Biological: 10 mg/kg, single dose IV administration of 10-1074

Group 2C

EXPERIMENTAL

HIV-uninfected individuals 30 mg/kg, single dose IV administration of 10-1074

Biological: 30 mg/kg, single dose IV administration of 10-1074

Group 2D

EXPERIMENTAL

HIV-uninfected individuals 30 mg/kg, single dose IV administration of 10-1074

Biological: 30 mg/kg, single dose IV administration of 10-1074

Interventions

3 mg/kg, single dose IV administration of 10-1074BIOLOGICAL

3 mg/kg, single dose IV administration of 10-1074

Group 1AGroup 2A
10 mg/kg, single dose IV administration of 10-1074BIOLOGICAL

10 mg/kg, single dose IV administration of 10-1074

Group 1BGroup 2B
30 mg/kg, single dose IV administration of 10-1074BIOLOGICAL

30 mg/kg, single dose IV administration of 10-1074

Group 1CGroup 1DGroup 2CGroup 2D

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Group 1 (HIV-infected)
  • Males and females, age 18 to 65
  • HIV-1 infection confirmed by two independent assays.
  • Group (1A-1C): HIV-infected individuals off ART for at least 8 weeks with HIV-1 plasma RNA levels \< 100,000 copies/ml by standard assays, or on ART with HIV-1 plasma RNA levels \< 500 copies/ml. HIV-1 RNA levels should be measured on 2 occasions, at least 1 week apart and one measurement must be performed within 49 days prior to enrollment.
  • Group (1D): HIV-infected individuals off ART for at least 8 weeks with HIV-1 plasma RNA levels \< 100,000 copies/ml by standard assays, measured on 2 occasions, at least 1 week apart. At least one measurement must be performed within 49 days prior to enrollment.
  • Current CD4 count \> 300 cells/μl.
  • If sexually active male or female, and participating in sexual activity that could lead to pregnancy, agrees to use two effective methods of contraception from 10 days prior to the 10-1074 infusion until the end of the study.
  • Group 2 (HIV-uninfected):
  • Males and females, age 18 to 65.
  • Amenable to HIV risk reduction counseling and agrees to maintain behavior consistent with low risk of HIV exposure.
  • If sexually active male or female, and participating in sexual activity that could lead to pregnancy, agrees to use two effective methods of contraception throughout the study period, as described for the HIV-infected groups above.

You may not qualify if:

  • Group 1 (HIV-infected):
  • Have a history of AIDS-defining illness within 1 year prior to enrollment.
  • History of systemic corticosteroids, immunosuppressive anti-cancer, or other medications considered significant by the trial physician within the last 6 months.
  • Any clinically significant acute or chronic medical condition other than HIV infection, that in the opinion of the investigator would preclude participation.
  • Chronic Hepatitis B or Hepatitis C infection.
  • Laboratory abnormalities in the parameters listed below:
  • Absolute neutrophil count ≤ 1,000; Hemoglobin ≤10 gm/dL; Platelet count ≤100,000; ALT ≥ 2.0 x ULN; AST ≥ 2.0 x ULN; Total bilirubin ≥ 1.25 x ULN; Creatinine ≥ 1.1 x ULN; Coagulation parameters (PT, PTT or INR) ≥ 1.25 x ULN.
  • Pregnancy or lactation.
  • Any vaccination within 14 days prior to 10-1074 administration.
  • History of severe reaction to a vaccine or drug infusion or history of severe allergic reactions.
  • Participation in another clinical study of an investigational product currently or within past 12 weeks, or expected participation during this study.
  • Group 2 (HIV-uninfected):
  • Confirmed HIV-1 or HIV-2 infection.
  • History of immunodeficiency or autoimmune disease; use of systemic corticosteroids, immunosuppressive anti-cancer, or other medications considered significant by the trial physician within the last 6 months.
  • Any clinically significant acute or chronic medical condition (such as autoimmune diseases) that in the opinion of the investigator would preclude participation.
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Rockefeller University

New York, New York, 10065, United States

Location

University of Cologne

Cologne, 50937, Germany

Location

Study Officials

  • Marina Caskey, MD

    Rockefeller University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2015

First Posted

July 30, 2015

Study Start

July 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2017

Last Updated

February 5, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)DE(1)