Human Immunodeficiency Virus (HIV)Phase 1NCT02825797
3BNC117 and 10-1074 in HIV-infected Individuals
A Phase 1 study testing 3BNC117, 10-1074 and Analytical treatment interruption in people with Human Immunodeficiency Virus (HIV), run by Rockefeller University at 2 sites in 2 countries.
Trial summary
This is a phase 1b clinical trial to evaluate the safety, pharmacokinetics and the antiretroviral effects of the combination of two anti-human immunodeficiency virus (HIV) broadly neutralizing antibodies, 3BNC117 and 10-1074, administered intravenously in HIV-infected individuals. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Human Immunodeficiency Virus (HIV)
- What is being tested?
- 3BNC117, 10-1074 and Analytical treatment interruption
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2016to 15 Aug 2018
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All groups:
- Age 18 to 65.
- HIV-1 infection confirmed by two independent laboratory assays.
- If sexually active male or female, and participating in sexual activity that could lead to pregnancy, agrees to use two effective methods of contraception (i.e. condom with spermicide, diaphragm with spermicide, hormone-eluting intrauterine device (IUD), hormone-based contraceptive with condom) for the study duration.
- Groups 1A and 1B:
- HIV-infected volunteers on ART with HIV-1 plasma RNA levels < 20 copies/ml.
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- Current CD4 cell count > 300 cells/μl.
- Groups 1C and 3:
- HIV-infected volunteers off ART with detectable HIV-1 plasma RNA levels < 100,000 copies/ml by standard assays.
- Current CD4 cell count > 300 cells/μl.
- Group 2:
- On antiretroviral therapy for a minimum of 24 months, with plasma HIV-1 RNA levels of < 50 copies/ml for at least 18 months, and < 20 copies/ml at screening. Note: a single viral load measurement > 50 but < 500 copies/ml during this time period is allowed.
- Current CD4+ T cell counts > 500 cells/μl. CD4 cell count nadir > 200 cells/μl.
- If on an NNRTI-based regimen willing to switch to a dolutegravir-based regimen for 4 weeks prior to discontinuing ART.
Who cannot join
- Have a history of AIDS-defining illness within 3 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 (such as autoimmune diseases or coronary artery disease), other than HIV infection, that in the opinion of the investigator would preclude participation.
- Hepatitis B or C infection as indicated by the presence of Hepatitis B surface antigen (HBsAg) or hepatitis C virus RNA (HCV-RNA) in blood.
- History of resistance to 2 or more classes of antiretroviral medication or known resistance to dolutegravir in participants on non-nucleoside reverse-transcriptase inhibitors (NNRTI), who would switch regimen prior to ATI (Group 2).
- Laboratory abnormalities in the parameters listed below:
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- Absolute neutrophil count ≤ 1,000 cells/l
- Hemoglobin ≤ 10 gm/dL
- Platelet count ≤ 100,000 cells/l
- Alanine Aminotransferase (AST) ≥ 1.5 x ULN
- Aspartate Aminotransferase (AST) ≥ 1.5 x ULN
- Alkaline phosphatase ≥ 1.5 x ULN
- Total bilirubin > 1.0 ULN
- eGFR < 60 mL/min/1.73m2
- Pregnancy or lactation;
- Any vaccination within 14 days prior to 3BNC117 and 10-1074 administration;
- Subjects with known hypersensitivity to any constituent of the investigational products;
- Receipt of any therapeutic HIV vaccine or 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
The Rockefeller University
New York, New York, 10065
About this study
Official title: An Phase 1b Study of the Safety, Pharmacokinetics and Antiretroviral Activity of the Combination of 3BNC117 and 10-1074 in HIV-infected Individuals
This is a phase 1b clinical trial to evaluate the safety, pharmacokinetics and the antiretroviral effects of the combination of two anti-human immunodeficiency virus (HIV) broadly neutralizing antibodies, 3BNC117 and 10-1074, administered intravenously in HIV-infected individuals. This study is intended to support the development of the combination of 3BNC117 and 10-1074 mAbs for use in the treatment of HIV-1 infection.
Read the detailed description
The proposed study is a Phase 1b clinical trial to evaluate the safety, pharmacokinetics and the antiretroviral effects of the combination of two anti-HIV broadly neutralizing antibodies, 3BNC117 and 10-1074, administered intravenously in HIV-infected individuals.
The study includes 5 study groups. Study participants will be administered one or three intravenous infusions of 3BNC117 and 10-1074, each mAb dosed at 10 or 30 mg/kg:
Single dose groups:
Group 1A (n=6) - HIV-infected individuals, on antiretroviral therapy (ART) with HIV-1 RNA < 20 copies/ml will be randomized in a 2:1 ratio to receive one intravenous infusion of 3BNC117 and one infusion of 10-1074, each dosed at 10 mg/kg (n=4), OR placebo (sterile saline; n=2), on day 0.
Group 1B (n=6) - HIV-infected individuals, on ART with HIV-1 RNA < 20 copies/ml will be randomized in a 2:1 ratio to receive one intravenous infusion of 3BNC117 and one infusion 10-1074, each dosed at 30 mg/kg (n=4), OR placebo (sterile saline; n=2), on day 0.
Participants and investigators will be blinded to study assignment in groups 1A and 1B.
Group 1C (n=4) - HIV-infected individuals, off ART will be administered one infusion of 3BNC117 and one infusion 10-1074, each dosed at 30 mg/kg, on day 0.
Three doses groups:
Group 2 (n=15) - HIV-infected individuals, on ART who will be administered three infusions of 3BNC117 and three infusions of 10-1074, each dosed at 30 mg/kg, on days 0, 21 (week 3) and 42 (week 6). Participants enrolled in Group 2 will discontinue their antiretroviral (ART) regimen on day 2.
Group 3 (n=6) - HIV-infected individuals, off ART who will be administered three infusions of 3BNC117 and three infusions of 10-1074, each dosed at 30 mg/kg on days 0, 14 (week 2) and 28 (week 4).
Following 3BNC117 and 10-1074 infusions, study participants will return for safety assessments at multiple time points. Blood samples will be collected for safety testing at weeks 1, 2, and 4 following each mAb infusion, then bi-monthly or monthly until the end of study follow up.
Serum samples for PK (pharmacokinetic) measurements will be collected before the start of the first mAb infusion. Peak PK sampling for 3BNC117 will occur following the completion of the 3BNC117 infusion and prior to the start of the 10-1074 infusion. Peak PK sampling for 10-1074 will occur following the completion of the 10-1074 infusion. Additional samples for PK assessments will be collected at multiple time points during study follow up.
Samples will also be collected for measurement of HIV-1 plasma RNA levels before 3BNC117 and 10-1074 infusions (screen, pre-infusion and day 0), at all follow up visits in Groups 1A, 1B and 2, and weekly during the ATI period and at later time points in Group 2.
All participants will be followed for 24 weeks after the last 3BNC117 and 10-1074 infusions.
- Conditions
- Human Immunodeficiency Virus (HIV)
- Being tested
- 3BNC117, 10-1074, Analytical treatment interruption, Placebo
- Keywords
- Broadly neutralizing antibody, 3BNC117, 10-1074
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3BNC117Drug
Also called Monoclonal Antibody
Intravenous infusion of 3BNC117
10-1074Drug
Also called Monoclonal Antibody
Intravenous infusion of 10-1074
Analytical treatment interruptionOther
Also called ART interruption
Analytical treatment interruption
PlaceboDrug
Also called Sterile Saline
Intravenous infusion of placebo (sterile saline)
| Study group | Role | What they receive |
|---|---|---|
| Group 1A | Experimental | HIV-infected individuals, on ART with HIV-1 RNA < 20 copies/ml will be randomized in a 2:1 ratio to receive one intravenous infusion of 3BNC117 and one intravenous infusion of 10-1074), each dosed at 10 mg/kg OR placebo (sterile saline), on day 0. Receives: Drug: 3BNC117; Drug: 10-1074; Drug: Placebo |
| Group 1B | Experimental | HIV-infected individuals, on ART with HIV-1 RNA < 20 copies/ml will be randomized in a 2:1 ratio to receive one intravenous infusion of 3BNC117 and one intravenous infusion 10-1074, each dosed at 30 mg/kg, OR placebo (sterile saline), on day 0. Receives: Drug: 3BNC117; Drug: 10-1074; Drug: Placebo |
| Group 1C | Experimental | HIV-infected individuals, off ART will be administered one infusion of 3BNC117 and one infusion 10-1074, each dosed at 30 mg/kg, on day 0. Receives: Drug: 3BNC117; Drug: 10-1074 |
| Group 2 | Experimental | HIV-infected individuals, on ART with HIV-1 RNA < 20 copies/ml will be administered three infusions of 3BNC117 and three infusions of 10-1074, each dosed at 30 mg/kg, on days 0, 21 and 42. Participants enrolled in Group 2 will undergo an analytical treatment interruption and they will discontinue their antiretroviral (ART) regimen on day 2. Receives: Drug: 3BNC117; Drug: 10-1074; Other: Analytical treatment interruption |
| Group 3 | Experimental | HIV-infected individuals, off ART who will be administered three infusions of 3BNC117 and three infusions of 10-1074, each dosed at 30 mg/kg on days 0, 14 and 28. Receives: Drug: 3BNC117; Drug: 10-1074 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of participants with adverse events 1 week after 3BNC117 and 10-1074 infusions in all study groups.
Adverse events include: signs, symptoms and laboratory abnormalities, in addition to local and systemic reactogenicity
Measured: 1 week following each combination of 3BNC117 and 10-1074 infusion
The decline in plasma HIV-1 RNA levels by a standard clinical assay in participants off ART enrolled in groups 1C and 3.
Measured: 20-24 weeks
The percentage of participants who meet ART re-initiation criteria (plasma HIV-1 RNA ≥ 200 copies/ml and/or CD4 count < 350 cells/μl on two consecutive measurements) prior to 8 weeks after ART interruption in group 2.
Measured: 30 weeks
Time to meeting ART re-initiation criteria (plasma HIV-1 RNA level ≥ 200 copies/ml, CD4+ T cell count < 350 cells/l in 2 consecutive measurements) following ART interruption in group 2.
Measured: 30 weeks
Secondary outcomes (5)
The number of participants with adverse events that occur during study follow up after 3BNC117 and 10-1074 infusions in all study groups.
Adverse events include signs, symptoms and laboratory abnormalities.
Measured: 20-30 weeks
The serum level of 3BNC117 and 10-1074 at the time of viral rebound in all study groups.
Measured: 20-30 weeks
Number of participants with induced anti-3BNC117 and anti-10-1074 antibodies.
Measured: 20-30 weeks
Level of induced anti-3BNC117 and anti-10-1074 antibodies.
Measured: 20-30 weeks
Change in number of CD4+ T cells/uL
Measured: 20-30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study startJun 2016
- Primary completion1 Aug 2018
- Study completion15 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency Virus (HIV)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rockefeller University
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of Cologne
- Responsible party
- Sponsor
- Investigators
- Marina Caskey, MD, Principal investigator, Rockefeller University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02825797
- Sponsor's protocol ID
- MCA-0906
- Status last verified
- Aug 2018
- First submitted
- 28 Jun 2016
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Phase 1b Study of the Safety, Pharmacokinetics and Antiretroviral Activity of the Combination of 3BNC117 and 10-1074 in HIV-infected Individuals
- ClinicalTrials.gov ID
- NCT02825797
- Acronym / sponsor ID
- MCA-0906
- Conditions
- Human Immunodeficiency Virus (HIV)
- Keywords
- Broadly neutralizing antibody, 3BNC117, 10-1074
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Rockefeller UniversityUniversity, hospital or other
- Collaborators
- University Hospital of Cologne
- Study start
- Jun 2016
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 15 Aug 2018 (actual)
- First posted
- 7 Jul 2016 (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.
This is a phase 1b clinical trial to evaluate the safety, pharmacokinetics and the antiretroviral effects of the combination of two anti-human immunodeficiency virus (HIV) broadly neutralizing antibodies, 3BNC117 and 10-1074, administered intravenously in HIV-infected individuals. This study is intended to support the development of the combination of 3BNC117 and 10-1074 mAbs for use in the treatment of HIV-1 infection.
Detailed description
The proposed study is a Phase 1b clinical trial to evaluate the safety, pharmacokinetics and the antiretroviral effects of the combination of two anti-HIV broadly neutralizing antibodies, 3BNC117 and 10-1074, administered intravenously in HIV-infected individuals.
The study includes 5 study groups. Study participants will be administered one or three intravenous infusions of 3BNC117 and 10-1074, each mAb dosed at 10 or 30 mg/kg:
Single dose groups:
Group 1A (n=6) - HIV-infected individuals, on antiretroviral therapy (ART) with HIV-1 RNA < 20 copies/ml will be randomized in a 2:1 ratio to receive one intravenous infusion of 3BNC117 and one infusion of 10-1074, each dosed at 10 mg/kg (n=4), OR placebo (sterile saline; n=2), on day 0.
Group 1B (n=6) - HIV-infected individuals, on ART with HIV-1 RNA < 20 copies/ml will be randomized in a 2:1 ratio to receive one intravenous infusion of 3BNC117 and one infusion 10-1074, each dosed at 30 mg/kg (n=4), OR placebo (sterile saline; n=2), on day 0.
Participants and investigators will be blinded to study assignment in groups 1A and 1B.
Group 1C (n=4) - HIV-infected individuals, off ART will be administered one infusion of 3BNC117 and one infusion 10-1074, each dosed at 30 mg/kg, on day 0.
Three doses groups:
Group 2 (n=15) - HIV-infected individuals, on ART who will be administered three infusions of 3BNC117 and three infusions of 10-1074, each dosed at 30 mg/kg, on days 0, 21 (week 3) and 42 (week 6). Participants enrolled in Group 2 will discontinue their antiretroviral (ART) regimen on day 2.
Group 3 (n=6) - HIV-infected individuals, off ART who will be administered three infusions of 3BNC117 and three infusions of 10-1074, each dosed at 30 mg/kg on days 0, 14 (week 2) and 28 (week 4).
Following 3BNC117 and 10-1074 infusions, study participants will return for safety assessments at multiple time points. Blood samples will be collected for safety testing at weeks 1, 2, and 4 following each mAb infusion, then bi-monthly or monthly until the end of study follow up.
Serum samples for PK (pharmacokinetic) measurements will be collected before the start of the first mAb infusion. Peak PK sampling for 3BNC117 will occur following the completion of the 3BNC117 infusion and prior to the start of the 10-1074 infusion. Peak PK sampling for 10-1074 will occur following the completion of the 10-1074 infusion. Additional samples for PK assessments will be collected at multiple time points during study follow up.
Samples will also be collected for measurement of HIV-1 plasma RNA levels before 3BNC117 and 10-1074 infusions (screen, pre-infusion and day 0), at all follow up visits in Groups 1A, 1B and 2, and weekly during the ATI period and at later time points in Group 2.
All participants will be followed for 24 weeks after the last 3BNC117 and 10-1074 infusions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1A | Experimental | Drug: 3BNC117, Drug: 10-1074, Drug: PlaceboHIV-infected individuals, on ART with HIV-1 RNA < 20 copies/ml will be randomized in a 2:1 ratio to receive one intravenous infusion of 3BNC117 and one intravenous infusion of 10-1074), each dosed at 10 mg/kg OR placebo (sterile saline), on day 0. |
| Group 1B | Experimental | Drug: 3BNC117, Drug: 10-1074, Drug: PlaceboHIV-infected individuals, on ART with HIV-1 RNA < 20 copies/ml will be randomized in a 2:1 ratio to receive one intravenous infusion of 3BNC117 and one intravenous infusion 10-1074, each dosed at 30 mg/kg, OR placebo (sterile saline), on day 0. |
| Group 1C | Experimental | Drug: 3BNC117, Drug: 10-1074HIV-infected individuals, off ART will be administered one infusion of 3BNC117 and one infusion 10-1074, each dosed at 30 mg/kg, on day 0. |
| Group 2 | Experimental | Drug: 3BNC117, Drug: 10-1074, Other: Analytical treatment interruptionHIV-infected individuals, on ART with HIV-1 RNA < 20 copies/ml will be administered three infusions of 3BNC117 and three infusions of 10-1074, each dosed at 30 mg/kg, on days 0, 21 and 42. Participants enrolled in Group 2 will undergo an analytical treatment interruption and they will discontinue their antiretroviral (ART) regimen on day 2. |
| Group 3 | Experimental | Drug: 3BNC117, Drug: 10-1074HIV-infected individuals, off ART who will be administered three infusions of 3BNC117 and three infusions of 10-1074, each dosed at 30 mg/kg on days 0, 14 and 28. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age 18 to 65.
- HIV-1 infection confirmed by two independent laboratory assays.
- If sexually active male or female, and participating in sexual activity that could lead to pregnancy, agrees to use two effective methods of contraception (i.e. condom with spermicide, diaphragm with spermicide, hormone-eluting intrauterine device (IUD), hormone-based contraceptive with condom) for the study duration.
- HIV-infected volunteers on ART with HIV-1 plasma RNA levels < 20 copies/ml.
- Current CD4 cell count > 300 cells/μl.
Key exclusion criteria (19 listed)
- Have a history of AIDS-defining illness within 3 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 (such as autoimmune diseases or coronary artery disease), other than HIV infection, that in the opinion of the investigator would preclude participation.
- Hepatitis B or C infection as indicated by the presence of Hepatitis B surface antigen (HBsAg) or hepatitis C virus RNA (HCV-RNA) in blood.
- History of resistance to 2 or more classes of antiretroviral medication or known resistance to dolutegravir in participants on non-nucleoside reverse-transcriptase inhibitors (NNRTI), who would switch regimen prior to ATI (Group 2).
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 |
|---|---|---|
| 3BNC117Also: Monoclonal AntibodyIntravenous infusion of 3BNC117 | Drug | Group 1A, Group 1B, Group 1C, Group 2, Group 3 |
| 10-1074Also: Monoclonal AntibodyIntravenous infusion of 10-1074 | Drug | Group 1A, Group 1B, Group 1C, Group 2, Group 3 |
| Analytical treatment interruptionAlso: ART interruptionAnalytical treatment interruption | Other | Group 2 |
| PlaceboAlso: Sterile SalineIntravenous infusion of placebo (sterile saline) | Drug | Group 1A, Group 1B |
Primary outcome
The number of participants with adverse events 1 week after 3BNC117 and 10-1074 infusions in all study groups.
Time frame: 1 week following each combination of 3BNC117 and 10-1074 infusion
Adverse events include: signs, symptoms and laboratory abnormalities, in addition to local and systemic reactogenicity
The decline in plasma HIV-1 RNA levels by a standard clinical assay in participants off ART enrolled in groups 1C and 3.
Time frame: 20-24 weeks
The percentage of participants who meet ART re-initiation criteria (plasma HIV-1 RNA ≥ 200 copies/ml and/or CD4 count < 350 cells/μl on two consecutive measurements) prior to 8 weeks after ART interruption in group 2.
Time frame: 30 weeks
Time to meeting ART re-initiation criteria (plasma HIV-1 RNA level ≥ 200 copies/ml, CD4+ T cell count < 350 cells/l in 2 consecutive measurements) following ART interruption in group 2.
Time frame: 30 weeks
5 secondary outcomes
The number of participants with adverse events that occur during study follow up after 3BNC117 and 10-1074 infusions in all study groups.
Time frame: 20-30 weeks
The serum level of 3BNC117 and 10-1074 at the time of viral rebound in all study groups.
Time frame: 20-30 weeks
Number of participants with induced anti-3BNC117 and anti-10-1074 antibodies.
Time frame: 20-30 weeks
Level of induced anti-3BNC117 and anti-10-1074 antibodies.
Time frame: 20-30 weeks
Change in number of CD4+ T cells/uL
Time frame: 20-30 weeks
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 21 Aug 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?
A Phase 1 study testing 3BNC117, 10-1074 and Analytical treatment interruption in people with Human Immunodeficiency Virus (HIV), run by Rockefeller University at 2 sites in 2 countries.
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 14 inclusion and 19 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 21 Aug 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?
The number of participants with adverse events 1 week after 3BNC117 and 10-1074 infusions in all study groups. (time frame: 1 week following each combination of 3BNC117 and 10-1074 infusion). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2018.