NCT01950325

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...

Completed Phase 1 Last updated 17 December 2019

What this trial tests

Phase 1 trial testing VRC-HIVMAB060-00-AB in HIV-1 Infection in 27 participants. Completed in 20 August 2015.

Timeline

22 August 2013

Primary endpoint
20 August 2015

20 August 2015

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	27
Start date	22 August 2013
Primary completion	20 August 2015
Estimated completion	20 August 2015
Sites	1 location across United States

Drugs / interventions tested

• VRC-HIVMAB060-00-AB — full drug profile →

Conditions studied

• HIV-1 Infection — all drugs for HIV-1 Infection →
• Neutralizing Antibody — all drugs for Neutralizing Antibody →
• Monoclonal Antibody — all drugs for Monoclonal Antibody →
• Viral Load — all drugs for Viral Load →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 18 to 70, any sex, with HIV-1 Infection or Neutralizing Antibody. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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 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.

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Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Virologic effects of broadly neutralizing antibody VRC01 administration during chronic HIV-1 infection.
   Lynch RM, Boritz E, Coates EE, DeZure A, et al · · 2015 · cited 398× · PMID 26702094 · DOI 10.1126/scitranslmed.aad5752
2. Broadly Neutralizing Antibodies for HIV-1 Prevention.
   Walsh SR, Seaman MS. · · 2021 · cited 73× · PMID 34354713 · DOI 10.3389/fimmu.2021.712122
3. Broadly neutralizing monoclonal antibodies for HIV prevention.
   Miner MD, Corey L, Montefiori D. · · 2021 · cited 34× · PMID 34806308 · DOI 10.1002/jia2.25829
4. The Use of Broadly Neutralizing Antibodies (bNAbs) in HIV-1 Treatment and Prevention.
   Thavarajah JJ, Hønge BL, Wejse CM. · · 2024 · cited 31× · PMID 38932203 · DOI 10.3390/v16060911
5. Adeno-associated virus gene delivery of broadly neutralizing antibodies as prevention and therapy against HIV-1.
   Lin A, Balazs AB. · · 2018 · cited 29× · PMID 30285769 · DOI 10.1186/s12977-018-0449-7
6. Potent anti-viral activity of a trispecific HIV neutralizing antibody in SHIV-infected monkeys.
   Pegu A, Xu L, DeMouth ME, Fabozzi G, et al · · 2022 · cited 27× · PMID 34986348 · DOI 10.1016/j.celrep.2021.110199
7. Vectored antibody gene delivery for the prevention or treatment of HIV infection.
   Deal CE, Balazs AB. · · 2015 · cited 27× · PMID 25700206 · DOI 10.1097/coh.0000000000000145
8. Clinical trials of broadly neutralizing monoclonal antibodies in people living with HIV - a review.
   Mahomed S, Pillay K, Hassan-Moosa R, Galvão BPGV, et al · · 2025 · cited 20× · PMID 40189566 · DOI 10.1186/s12981-025-00734-8