HIV-1 InfectionPhase 1NCT01950325
VRC 601: A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC HIVMAB060-00-AB (VRC01), With Broad HIV-1 Neutralizing Activity, Administered Intravenously or Subcutaneously to HIV-Infected...
A Phase 1 study testing VRC-HIVMAB060-00-AB in people with HIV-1 Infection and Neutralizing Antibody, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
This is the first clinical trial of the VRC-HIVMAB060-00-AB (VRC01) monoclonal antibody. VRC01 is a broadly neutralizing antibody directed against HIV. This is a dose-escalation study to examine safety, tolerability, dose and pharmacokinetics of VRC01. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- HIV-1 Infection, Neutralizing Antibody, Monoclonal Antibody
- What is being tested?
- VRC-HIVMAB060-00-AB
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2013to 20 Aug 2015
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A volunteer must meet all of the following criteria:
- Able and willing to complete the informed consent process.
- 18-60 years old during the dose escalation; 18-70 years old during subsequent enrollment of viremic subjects.
- HIV infected and clinically stable,Volunteers during the dose escalation part of the study also must be, without changes in ARV status (whether or not taking an ARV regimen) in the 24 weeks prior to enrollment.
- Criteria for volunteers enrolling during the dose escalation part of the study:
- Plasma viral load (VL) and CD4 count that meet eligibility criteria on at least two measurements performed within the 24 weeks prior to enrollment. The two measurements used for eligibility must have at least 3 days between tests and at least one set of the tests must be performed at the NIH Clinical Center within the 84 days prior to enrollment.
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- If not on ARV treatment, the criteria are:
- -VL less than or equal to 50,000 copies/mL and a CD4 count greater than or equal to 400/mcL.
- If on ARV treatment, the criteria are:
- -VL less than or equal to 50 copies/mL and a CD4 count greater than or equal to 350/mcL.
- Note: A viral blip of <400 copies/mL during the 24 weeks prior to enrollment is permitted if preceded and followed by test results showing VL less than or equal to 50 copies/mL on the same ARV regimen.]
- Criteria for viremic volunteers enrolling after dose escalation is complete:
- At least one detectable plasma viral load greater than or equal to 50 copies/mL and at least one CD4 count greater than or equal to 200 cells/mcL within 84 days prior to enrollment.
- Note: Up to 10 viremic subjects will be enrolled but no more than 4 subjects with a screening VL >100,000 copies/mL will receive VRC01. Other subjects must have a screening VL less than or equal to 100,000 copies/mL
- In general good health and willing to maintain or establish a relationship with a primary health care provider for medical management of HIV infection while participating in the study.
- Willing to have blood samples collected, stored indefinitely, and used for various research purposes.
- Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
- Screening laboratory values within 84 days prior to enrollment must meet the following criteria:
- absolute neutrophil count greater than or equal to 800/mcL
- platelets greater than or equal to 100,000/mcL
- hemoglobin greater than or equal to 10.0 gm/dL
- creatinine less than or equal to 1.31 mg/dL
- alanine aminotransferase (ALT) less than or equal to 2.5 times ULN
- Female-Specific Criteria:
- Agrees not to become pregnant from the time of study enrollment until the last study visit. If a woman is sexually active and has no history of hysterectomy or tubal ligation or menopause, she must agree to use a prescription birth control method or a barrier birth control method.
- Negative Beta-HCG (human chorionic gonadotropin) pregnancy test (urine or serum) on day of enrollment for any women unless she is post-menopause for 24 consecutive months or has undergone a surgical procedure that precludes pregnancy.
Who cannot join
- A volunteer will be excluded if one or more of the following conditions apply:
- Previous receipt of humanized or human monoclonal antibody whether licensed or investigational.
- Weight >130 kg or <53 kg.
- Ongoing AIDS-related opportunistic infection (including oral thrush)
- Active injection drug use or active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- History of a severe allergic reaction with generalized urticaria, angioedema or anaphylaxis in the 2 years prior to enrollment.
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- Physical finding on examination considered clinically significant such as murmur (other than functional), hepatosplenomegaly, lymphadenopathy or focal neurological deficit.
- Hypertension that is not well controlled by medication.
- Breast-feeding.
- Receipt of other investigational study agent within 28 days prior to enrollment.
- Any other chronic or clinically significant medical condition that in the opinion of investigator would jeopardize the safety or rights of the volunteer.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: VRC 601: A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC HIVMAB060-00-AB (VRC01), With Broad HIV-1 Neutralizing Activity, Administered Intravenously or Subcutaneously to HIV-Infected Adults
This is the first clinical trial of the VRC-HIVMAB060-00-AB (VRC01) monoclonal antibody. VRC01 is a broadly neutralizing antibody directed against HIV. This is a dose-escalation study to examine safety, tolerability, dose and pharmacokinetics of VRC01. The hypothesis is that VRC01 will be safe for administration to HIV-1 infected adults by the intravenous (IV) and subcutaneous (SC) routes and will not elicit hypersensitivity reactions. Samples will be collected to learn if VRC01 is detectable in mucosal secretions and blood of participants and how long VRC01 can be detected in the blood after it is given.
Between 15 and 25 HIV-1 infected adults, ages 18-70 years will be enrolled. There are 4 dose escalation groups for IV administration; the doses are 1 mg/kg, 5 mg/kg, 20 mg/kg and 40 mg/kg. There is 1 group for SC administration at 5 mg/kg. Each group is expected to include at least 3 participants. Each participant will receive two infusions of VRC01 with about 1 month between doses. Infusions are administered in an inpatient unit and an overnight stay at the NIH Clinical Center is required. No more than one subject per day per group will receive a first infusion of the VRC01 product by the IV route and no more than one subject per week will receive a first infusion of the product by the SC route. Study participation lasts for 24 weeks. Participant health and effect on CD4 count and HIV viral load will be monitored. Samples will be collected and stored for research purposes.
...
Read the detailed description
This is the first clinical trial of the VRC-HIVMAB060-00-AB (VRC01) monoclonal antibody. VRC01 is a broadly neutralizing antibody directed against HIV. This is a dose-escalation study to examine safety, tolerability, dose and pharmacokinetics of VRC01. The hypothesis is that VRC 01 will be safe for administration to HIV-1- infected adults by the intravenous (IV) and subcutaneous (SC) routes and will not elicit hypersensitivity reactions. Samples will be collected to learn if VRC01 is detectable in mucosal secretions and blood of participants and how long VRC01 can be detected in the blood after it is given.
Up to 30 HIV-1 infected adults will be enrolled. Adult 18-60 years old will participate in the dose escalation part of the study. There are 4 dose escalation groups for IV administration; the doses are 1 mg/kg, 5 mg/kg, 20 mg/kg and 40 mg/kg. There is 1 group for SC administration at 5 mg/kg. Each dose escalation group is expected to include at least 3 participants. Each participant during the dose escalation part of the study will receive two infusions of VRC01 with about 1 month between doses, with infusions administered in an inpatient unit and an overnight stay at the NIH Clinical Center required. No more than one subject per day per group will receive a first infusion of the VRC01 product by the IV route and no more than one subject per week will receive a first infusion of the product by the SC route. Study participation lasts for 24 weeks for participants who receive two doses. After the dose escalation is completed, about 10 HIV-infected adults, ages 18-70 years old, with detectable viral load will be enrolled to receive one dose of VRC01 at 40 mg/kg IV with follow-up for 12 weeks. Participant health and effect on CD4 count and HIV viral load will be monitored. Samples will be collected and stored for research purposes.
- Being tested
- VRC-HIVMAB060-00-AB
- Keywords
- HIV-1 Viral Load, CD4 Count, Antiviral, HIV-1 Infection, Broadly Neutralizing Antibody
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VRC-HIVMAB060-00-ABBiological
VRC01 Human Monoclonal Antibody
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 1mg/kg IV Receives: Biological: VRC-HIVMAB060-00-AB |
| Group 2 or Group 3 | Experimental | 5 mg/kg IV (Group 2) or 5 mg/kg SC (Group 3)[only portion of the study that is randomized] Receives: Biological: VRC-HIVMAB060-00-AB |
| Group 4 | Experimental | 20 mg/kg IV Receives: Biological: VRC-HIVMAB060-00-AB |
| Group 5 | Experimental | 40 mg/kg IV Receives: Biological: VRC-HIVMAB060-00-AB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events of all severities
Measured: From first product admin thru 56 days after last admin
Solicited systemic adverse events
Measured: For 3 days after ea product admin
Serious adverse events and new chronic medical conditions requiring ongoing medical management
Measured: From first product admin thru Study Week 24
Secondary outcomes (2)
Pharmacokinetics at each dose level
Measured: Thru 4 weeks after first dose and thru 8 wks after second dose
Assess whether anti-drug antibody can be detected in study agent recipients
Measured: From first product admin thru Study Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2013 (estimated)
- Study start22 Aug 2013
- Primary completion20 Aug 2015
- Study completion20 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HIV-1 InfectionStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Julie E Ledgerwood, D.O., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01950325
- Sponsor's protocol ID
- 130189
- Other IDs
- 13-I-0189
- Status last verified
- 20 Aug 2015
- First submitted
- 21 Sep 2013
- Last updated
- 17 Dec 2019
- Results posted
- No
Publications
Wu X, Yang ZY, Li Y, Hogerkorp CM, Schief WR, Seaman MS, Zhou T, Schmidt SD, Wu L, Xu L, Longo NS, McKee K, O'Dell S, Louder MK, Wycuff DL, Feng Y, Nason M, Doria-Rose N, Connors M, Kwong PD, Roederer M, Wyatt RT, Nabel GJ, Mascola JR. Rational design of envelope identifies broadly neutralizing human monoclonal antibodies to HIV-1. Science. 2010 Aug 13;329(5993):856-61. doi: 10.1126/science.1187659. Epub 2010 Jul 8.
PubMed 20616233Wu X, Wang C, O'Dell S, Li Y, Keele BF, Yang Z, Imamichi H, Doria-Rose N, Hoxie JA, Connors M, Shaw GM, Wyatt RT, Mascola JR. Selection pressure on HIV-1 envelope by broadly neutralizing antibodies to the conserved CD4-binding site. J Virol. 2012 May;86(10):5844-56. doi: 10.1128/JVI.07139-11. Epub 2012 Mar 14.
PubMed 22419808Lynch RM, Tran L, Louder MK, Schmidt SD, Cohen M; CHAVI 001 Clinical Team Members; Dersimonian R, Euler Z, Gray ES, Abdool Karim S, Kirchherr J, Montefiori DC, Sibeko S, Soderberg K, Tomaras G, Yang ZY, Nabel GJ, Schuitemaker H, Morris L, Haynes BF, Mascola JR. The development of CD4 binding site antibodies during HIV-1 infection. J Virol. 2012 Jul;86(14):7588-95. doi: 10.1128/JVI.00734-12. Epub 2012 May 9.
PubMed 22573869Lai Y-T, Dingens AS, DeMouth M, Helmold Hait S, O'Dell S, Schon A, Olia AS, Wang T, Shrader HR, Lovelace SE, Pegu A, Doria-Rose NA, Mascola JR, Bloom JD, Kwong PD. Fostemsavir analog BMS-818251 has enhanced viral neutralization potency and similar escape mutation profile. Antimicrob Agents Chemother. 2025 Oct;69(10):e0191024. doi: 10.1128/aac.01910-24. Epub 2025 Aug 27.
PubMed 40863730Lynch RM, Boritz E, Coates EE, DeZure A, Madden P, Costner P, Enama ME, Plummer S, Holman L, Hendel CS, Gordon I, Casazza J, Conan-Cibotti M, Migueles SA, Tressler R, Bailer RT, McDermott A, Narpala S, O'Dell S, Wolf G, Lifson JD, Freemire BA, Gorelick RJ, Pandey JP, Mohan S, Chomont N, Fromentin R, Chun TW, Fauci AS, Schwartz RM, Koup RA, Douek DC, Hu Z, Capparelli E, Graham BS, Mascola JR, Ledgerwood JE; VRC 601 Study Team. Virologic effects of broadly neutralizing antibody VRC01 administration during chronic HIV-1 infection. Sci Transl Med. 2015 Dec 23;7(319):319ra206. doi: 10.1126/scitranslmed.aad5752.
PubMed 26702094
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VRC 601: A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC HIVMAB060-00-AB (VRC01), With Broad HIV-1 Neutralizing Activity, Administered Intravenously or Subcutaneously to HIV-Infected Adults
- ClinicalTrials.gov ID
- NCT01950325
- Acronym / sponsor ID
- 130189
- Keywords
- HIV-1 Viral Load, CD4 Count, Antiviral, HIV-1 Infection, Broadly Neutralizing Antibody
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 22 Aug 2013
- Primary completion
- 20 Aug 2015 (actual)
- Study completion
- 20 Aug 2015 (actual)
- First posted
- 25 Sep 2013 (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 the first clinical trial of the VRC-HIVMAB060-00-AB (VRC01) monoclonal antibody. VRC01 is a broadly neutralizing antibody directed against HIV. This is a dose-escalation study to examine safety, tolerability, dose and pharmacokinetics of VRC01. The hypothesis is that VRC01 will be safe for administration to HIV-1 infected adults by the intravenous (IV) and subcutaneous (SC) routes and will not elicit hypersensitivity reactions. Samples will be collected to learn if VRC01 is detectable in mucosal secretions and blood of participants and how long VRC01 can be detected in the blood after it is given.
Between 15 and 25 HIV-1 infected adults, ages 18-70 years will be enrolled. There are 4 dose escalation groups for IV administration; the doses are 1 mg/kg, 5 mg/kg, 20 mg/kg and 40 mg/kg. There is 1 group for SC administration at 5 mg/kg. Each group is expected to include at least 3 participants. Each participant will receive two infusions of VRC01 with about 1 month between doses. Infusions are administered in an inpatient unit and an overnight stay at the NIH Clinical Center is required. No more than one subject per day per group will receive a first infusion of the VRC01 product by the IV route and no more than one subject per week will receive a first infusion of the product by the SC route. Study participation lasts for 24 weeks. Participant health and effect on CD4 count and HIV viral load will be monitored. Samples will be collected and stored for research purposes.
...
Detailed description
This is the first clinical trial of the VRC-HIVMAB060-00-AB (VRC01) monoclonal antibody. VRC01 is a broadly neutralizing antibody directed against HIV. This is a dose-escalation study to examine safety, tolerability, dose and pharmacokinetics of VRC01. The hypothesis is that VRC 01 will be safe for administration to HIV-1- infected adults by the intravenous (IV) and subcutaneous (SC) routes and will not elicit hypersensitivity reactions. Samples will be collected to learn if VRC01 is detectable in mucosal secretions and blood of participants and how long VRC01 can be detected in the blood after it is given.
Up to 30 HIV-1 infected adults will be enrolled. Adult 18-60 years old will participate in the dose escalation part of the study. There are 4 dose escalation groups for IV administration; the doses are 1 mg/kg, 5 mg/kg, 20 mg/kg and 40 mg/kg. There is 1 group for SC administration at 5 mg/kg. Each dose escalation group is expected to include at least 3 participants. Each participant during the dose escalation part of the study will receive two infusions of VRC01 with about 1 month between doses, with infusions administered in an inpatient unit and an overnight stay at the NIH Clinical Center required. No more than one subject per day per group will receive a first infusion of the VRC01 product by the IV route and no more than one subject per week will receive a first infusion of the product by the SC route. Study participation lasts for 24 weeks for participants who receive two doses. After the dose escalation is completed, about 10 HIV-infected adults, ages 18-70 years old, with detectable viral load will be enrolled to receive one dose of VRC01 at 40 mg/kg IV with follow-up for 12 weeks. Participant health and effect on CD4 count and HIV viral load will be monitored. Samples will be collected and stored for research purposes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: VRC-HIVMAB060-00-AB1mg/kg IV |
| Group 2 or Group 3 | Experimental | Biological: VRC-HIVMAB060-00-AB5 mg/kg IV (Group 2) or 5 mg/kg SC (Group 3)[only portion of the study that is randomized] |
| Group 4 | Experimental | Biological: VRC-HIVMAB060-00-AB20 mg/kg IV |
| Group 5 | Experimental | Biological: VRC-HIVMAB060-00-AB40 mg/kg IV |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Able and willing to complete the informed consent process.
- 18-60 years old during the dose escalation; 18-70 years old during subsequent enrollment of viremic subjects.
- HIV infected and clinically stable,Volunteers during the dose escalation part of the study also must be, without changes in ARV status (whether or not taking an ARV regimen) in the 24 weeks prior to enrollment.
- Criteria for volunteers enrolling during the dose escalation part of the study:
- Plasma viral load (VL) and CD4 count that meet eligibility criteria on at least two measurements performed within the 24 weeks prior to enrollment. The two measurements used for eligibility must have at least 3 days between tests and at least one set of the tests must be performed at the NIH Clinical Center within the 84 days prior to enrollment.
Key exclusion criteria (11 listed)
- Previous receipt of humanized or human monoclonal antibody whether licensed or investigational.
- Weight >130 kg or <53 kg.
- Ongoing AIDS-related opportunistic infection (including oral thrush)
- Active injection drug use or active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- History of a severe allergic reaction with generalized urticaria, angioedema or anaphylaxis in the 2 years prior to enrollment.
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 |
|---|---|---|
| VRC-HIVMAB060-00-ABVRC01 Human Monoclonal Antibody | Biological | Group 1, Group 2 or Group 3, Group 4, Group 5 |
Primary outcome
Adverse events of all severities
Time frame: From first product admin thru 56 days after last admin
Solicited systemic adverse events
Time frame: For 3 days after ea product admin
Serious adverse events and new chronic medical conditions requiring ongoing medical management
Time frame: From first product admin thru Study Week 24
2 secondary outcomes
Pharmacokinetics at each dose level
Time frame: Thru 4 weeks after first dose and thru 8 wks after second dose
Assess whether anti-drug antibody can be detected in study agent recipients
Time frame: From first product admin thru Study Week 24
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 17 Dec 2019.
- Background: PubMed 20616233Wu X, Yang ZY, Li Y, Hogerkorp CM, Schief WR, Seaman MS, Zhou T, Schmidt SD, Wu L, Xu L, Longo NS, McKee K, O'Dell S, Louder MK, Wycuff DL, Feng Y, Nason M, Doria-Rose N, Connors M, Kwong PD, Roederer M, Wyatt RT, Nabel GJ, Mascola JR. Rational design of envelope identifies broadly neutralizing human monoclonal antibodies to HIV-1. Science. 2010 Aug 13;329(5993):856-61. doi: 10.1126/science.1187659. Epub 2010 Jul 8.
- Background: PubMed 22419808Wu X, Wang C, O'Dell S, Li Y, Keele BF, Yang Z, Imamichi H, Doria-Rose N, Hoxie JA, Connors M, Shaw GM, Wyatt RT, Mascola JR. Selection pressure on HIV-1 envelope by broadly neutralizing antibodies to the conserved CD4-binding site. J Virol. 2012 May;86(10):5844-56. doi: 10.1128/JVI.07139-11. Epub 2012 Mar 14.
- Background: PubMed 22573869Lynch RM, Tran L, Louder MK, Schmidt SD, Cohen M; CHAVI 001 Clinical Team Members; Dersimonian R, Euler Z, Gray ES, Abdool Karim S, Kirchherr J, Montefiori DC, Sibeko S, Soderberg K, Tomaras G, Yang ZY, Nabel GJ, Schuitemaker H, Morris L, Haynes BF, Mascola JR. The development of CD4 binding site antibodies during HIV-1 infection. J Virol. 2012 Jul;86(14):7588-95. doi: 10.1128/JVI.00734-12. Epub 2012 May 9.
- Derived from this study: PubMed 40863730Lai Y-T, Dingens AS, DeMouth M, Helmold Hait S, O'Dell S, Schon A, Olia AS, Wang T, Shrader HR, Lovelace SE, Pegu A, Doria-Rose NA, Mascola JR, Bloom JD, Kwong PD. Fostemsavir analog BMS-818251 has enhanced viral neutralization potency and similar escape mutation profile. Antimicrob Agents Chemother. 2025 Oct;69(10):e0191024. doi: 10.1128/aac.01910-24. Epub 2025 Aug 27.
- Derived from this study: PubMed 26702094Lynch RM, Boritz E, Coates EE, DeZure A, Madden P, Costner P, Enama ME, Plummer S, Holman L, Hendel CS, Gordon I, Casazza J, Conan-Cibotti M, Migueles SA, Tressler R, Bailer RT, McDermott A, Narpala S, O'Dell S, Wolf G, Lifson JD, Freemire BA, Gorelick RJ, Pandey JP, Mohan S, Chomont N, Fromentin R, Chun TW, Fauci AS, Schwartz RM, Koup RA, Douek DC, Hu Z, Capparelli E, Graham BS, Mascola JR, Ledgerwood JE; VRC 601 Study Team. Virologic effects of broadly neutralizing antibody VRC01 administration during chronic HIV-1 infection. Sci Transl Med. 2015 Dec 23;7(319):319ra206. doi: 10.1126/scitranslmed.aad5752.
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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.
Julie E Ledgerwood, D.O. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VRC-HIVMAB060-00-AB in people with HIV-1 Infection and Neutralizing Antibody, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
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 26 inclusion and 11 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 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Adverse events of all severities (time frame: From first product admin thru 56 days after last admin). The study lists 3 primary outcomes in all. 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 NCT01950325, which also lists 5 linked publications.
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 17 Dec 2019.