HealthyPhase 1NCT02511990

A Study of the Safety, Pharmacokinetics and Antiretroviral Activity of 10-1074

A Phase 1 study testing 3 mg/kg, single dose IV administration of 10-1074, 10 mg/kg, single dose IV administration of 10-1074 and 30 mg/kg, single dose IV administration of 10-1074 in people with Healthy and HIV, run by Rockefeller University at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy, HIV
What is being tested?: 3 mg/kg, single dose IV administration of 10-1074, 10 mg/kg, single dose IV administration of 10-1074 and 30 mg/kg, single dose IV administration of 10-1074
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 33 participants
Where: 2 sitesin 2 countries
Study dates: Jul 2015to Dec 2017
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

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:

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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.
Within the 12 months prior to enrollment, the volunteer has a history of sexually transmitted infection.
Chronic Hepatitis B or Hepatitis C infection.
Laboratory abnormalities in the parameters listed:
Absolute neutrophil count ≤ 1,500; Hemoglobin ≤ 12 gm/dL if female; ≤ 13.5 gm/dL if male; Platelet count ≤ 140,000; Alanine transaminase (ALT) ≥ 1.25 x upper limit of normal (ULN); aspartate transaminase (AST) ≥ 1.25 x ULN; Total bilirubin ≥ 1.25 x ULN; Creatinine ≥ 1.1 x ULN; Coagulation parameters (prothrombin time - PT, partial thromboplastin time - PTT or INR) ≥ 1.25 x ULN.
Pregnancy or lactation.
Any vaccination within 14 days prior to 10-1074 administration.
Receipt of any experimental HIV vaccine in the past.
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.

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

United States1 site

The Rockefeller University
New York, New York, 10065

Other trials in United States

Germany1 site

University of Cologne
Cologne, 50937

Other trials in Germany

About this study

Official title: A Phase 1, Open Label, Dose-escalation Study of the Safety, Pharmacokinetics and Antiretroviral Activity of 10-1074 Monoclonal Antibody in HIV-infected and HIV-uninfected Individuals

Read the detailed description

In preclinical studies carried out in humanized mice and non-human primates, 10-1074 alone or in combination with other neutralizing antibodies led to protection from HIV or simian/human immunodeficiency virus (SHIV) infection and also to sustained suppression of HIV plasma viremia. The aims of this protocol are to evaluate the safety, tolerability and pharmacokinetics profile of 10-1074 in both HIV-infected and HIV-uninfected individuals, and its antiretroviral activity in HIV-infected individuals.

Conditions: Healthy, HIV
Being tested: 3 mg/kg, single dose IV administration of 10-1074, 10 mg/kg, single dose IV administration of 10-1074, 30 mg/kg, single dose IV administration of 10-1074
Keywords: HIV, 10-1074, Monoclonal Antibody

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT02511990
Study group	Role	What they receive
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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Biological: 30 mg/kg, single dose IV administration of 10-1074

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: 24 weeks after 10-1074 administration

Secondary outcomes (3)

Serum peak concentration of 10-1074, measured in micrograms per ml
Measured: 24 hours after 10-1074 administration
Serum half-life of 10-1074 expressed in days
Measured: 24 Weeks after 10-1074 administration
Plasma HIV-1 RNA levels measured in copies/ml
Measured: 2 weeks after 10-1074 administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2015Dec 2017

First posted30 Jul 2015 (estimated)
Study startJul 2015
Primary completionDec 2016
Study completionDec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02511990
Sponsor's protocol ID: MCA-0885
Status last verified: Jan 2018
First submitted: 24 Jul 2015
Last updated: 5 Feb 2018
Results posted: No
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open Label, Dose-escalation Study of the Safety, Pharmacokinetics and Antiretroviral Activity of 10-1074 Monoclonal Antibody in HIV-infected and HIV-uninfected Individuals
ClinicalTrials.gov ID: NCT02511990
Acronym / sponsor ID: MCA-0885
Conditions: Healthy, HIV
Keywords: HIV, 10-1074, Monoclonal Antibody
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 33 participants (actual)
Lead sponsor: Rockefeller UniversityUniversity, hospital or other
Collaborators: University of Cologne
Study start: Jul 2015
Primary completion: Dec 2016 (actual)
Study completion: Dec 2017 (actual)
First posted: 30 Jul 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 8

Arm	Type	Receives
Group 1A	Experimental	Biological: 3 mg/kg, single dose IV administration of 10-1074HIV-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
Group 1B	Experimental	Biological: 10 mg/kg, single dose IV administration of 10-1074HIV-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
Group 1C	Experimental	Biological: 30 mg/kg, single dose IV administration of 10-1074HIV-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
Group 1D	Experimental	Biological: 30 mg/kg, single dose IV administration of 10-1074HIV-infected individuals Off ART, HIV-1 viral load < 100,000 copies/ml 30 mg/kg, single dose IV administration of 10-1074
Group 2A	Experimental	Biological: 3 mg/kg, single dose IV administration of 10-1074HIV-uninfected individuals 3 mg/kg, single dose IV administration of 10-1074
Group 2B	Experimental	Biological: 10 mg/kg, single dose IV administration of 10-1074HIV-uninfected individuals 10 mg/kg, single dose IV administration of 10-1074
Group 2C	Experimental	Biological: 30 mg/kg, single dose IV administration of 10-1074HIV-uninfected individuals 30 mg/kg, single dose IV administration of 10-1074
Group 2D	Experimental	Biological: 30 mg/kg, single dose IV administration of 10-1074HIV-uninfected individuals 30 mg/kg, single dose IV administration of 10-1074

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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.

Key exclusion criteria (24 listed)

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:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
3 mg/kg, single dose IV administration of 10-10743 mg/kg, single dose IV administration of 10-1074	Biological	Group 1A, Group 2A
10 mg/kg, single dose IV administration of 10-107410 mg/kg, single dose IV administration of 10-1074	Biological	Group 1B, Group 2B
30 mg/kg, single dose IV administration of 10-107430 mg/kg, single dose IV administration of 10-1074	Biological	Group 1C, Group 1D, Group 2C, Group 2D

Primary outcome

Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 24 weeks after 10-1074 administration

3 secondary outcomes

Serum peak concentration of 10-1074, measured in micrograms per ml
Time frame: 24 hours after 10-1074 administration
Serum half-life of 10-1074 expressed in days
Time frame: 24 Weeks after 10-1074 administration
Plasma HIV-1 RNA levels measured in copies/ml
Time frame: 2 weeks after 10-1074 administration

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marina Caskey, MD principal investigator

Rockefeller University

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Adverse Events as a Measure of Safety and Tolerability (time frame: 24 weeks after 10-1074 administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02511990.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2018.