Safety and Virologic Effect of a Human Monoclonal Antibody (VRC01) Administered Intravenously to Adults During Early Acute HIV Infection

NCT02591420 | Completed Phase 1 Results DMC

• 3 other identifiers: RV 39812002WRAIR 2166
• Study Type: interventional
• Target: 24
• Locations: 4 countries
• Sites: 5

Brief Summary

This study will evaluate the safety and virologic effect of an experimental human monoclonal antibody (mAb), VRC-HIVMAB060-00-AB (VRC01), alone or in combination with antiretroviral therapy (ART), in adults during early acute HIV infection.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Grade 3 or Greater mAb-related Reactogenicity and mAb-related Adverse Events (AEs)

  This outcome is the combined total number of grade 3 or higher mAb-related reactogenicity events and mAb-related adverse events for each group. Only grade 3 reactogenicity events/AEs that are determined by the study physicians to be related to mAb are included. Adverse events, including reactogenicity events, are graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events v2.0 dated November 2014. This outcome is the total number of solicited adverse events (reactogenicity events) that had a severity of grade 3 or higher and were related to the mAb. Note that higher grades indicate worse severity.

  Measured through Week 24

• Plasma Viral Load Change From Day 0 to Day 7

  Measured through Day 7

Secondary Outcomes (10)

• Time to Virologic Suppression (Less Than 50 Copies/ml) in Plasma

  Measured through Week 24

• Number of Total Viremic Copy Days (Area Under Viral Load Curve) From Day 0 to Week 24

  Measured through Week 24

• Measurement of Plasma Viremia Including Single Copy HIV RNA Quantification

  Measured through Week 24

• Measurement of Cell-associated HIV RNA and DNA in the Peripheral Compartment

  Measured through Week 24 (Day 168)

• Percentage of Participants Experiencing Acute Retroviral Syndrome

  Measured through Week 24

Study Arms (3)

Group 1: immediate ART and placebo infusion

EXPERIMENTAL

Participants will start ART and will receive a single infusion of placebo at Day 0.

Biological: Placebo for VRC01; Drug: Antiretroviral therapy (ART) (regimen will vary within countries and by patient)

Group 2: immediate ART and VRC01 infusion

EXPERIMENTAL

Participants will start ART and receive a single infusion of VRC01 at Day 0.

Biological: VRC01; Drug: Antiretroviral therapy (ART) (regimen will vary within countries and by patient)

Group 3: immediate VRC01 infusion and subsequent ART

EXPERIMENTAL

Participants will receive a single infusion of VRC01 on Day 0 followed by ART initiation on Day 7.

Biological: VRC01; Drug: Antiretroviral therapy (ART) (regimen will vary within countries and by patient)

Interventions

Placebo for VRC01 BIOLOGICAL

Administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump

Group 1: immediate ART and placebo infusion

Antiretroviral therapy (ART) (regimen will vary within countries and by patient) DRUG

ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure.

Group 1: immediate ART and placebo infusion; Group 2: immediate ART and VRC01 infusion; Group 3: immediate VRC01 infusion and subsequent ART

VRC01 BIOLOGICAL

40 mg/kg of VRC01 will be administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump

Also known as: VRC-HIVMAB060-00-AB

Group 2: immediate ART and VRC01 infusion; Group 3: immediate VRC01 infusion and subsequent ART

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Able and willing to complete the informed consent process
• Passes Test of Understanding
• to 50 years of age
• Experiencing early acute HIV-1 infection as defined by blood samples on at least two separate days positive by nucleic acid testing within 21 days of a negative nucleic acid HIV-1 test OR by a positive nucleic acid test or a positive 4th generation enzyme immunoassay (EIA) in the context of a negative 2nd or negative 3rd generation HIV EIA test
• No history of antiretroviral therapy for any indication in the last 30 days.
• In general good health
• Willing to have blood samples collected and stored
• Able to participate for 25 weeks for study visits
• Willing to have photo or fingerprint taken for identification purposes
• Female-Specific Criteria:
• Agrees not to become pregnant from the time of study enrollment until the last study visit. If a woman has no history of hysterectomy, tubal ligation or menopause, she must agree to use an effective birth control method: abstinence; male or female condoms; diaphragm or cervical cap with spermicide; intrauterine device; contraceptive hormones delivered by pills, patch, injections, or vaginally; and hormonal implants under the skin; or a male partner who has previously undergone a vasectomy.
• Negative beta-human chorionic gonadotropin (HCG) pregnancy test (urine or serum) on day of enrollment for any woman unless she is post-menopause for 24 consecutive months or has undergone a surgical procedure that precludes pregnancy

You may not qualify if:

• Weight less than 46 kg or greater than 115 kg
• Previous receipt of humanized or human monoclonal antibody whether licensed or investigational
• Ongoing AIDS-related opportunistic infection (including oral thrush or active tuberculosis)
• Severe acute retroviral syndrome (as defined in Appendix I of the protocol) or clinical condition (other than HIV infection) constituting an indication for immediate antiretroviral therapy per local country guidelines
• Active injection drug use within previous 12 months
• History of a severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis in the 2 years prior to enrollment
• History of chronic urticaria
• Physical finding on examination considered indicative of significant disease such as murmur (other than functional), hepatosplenomegaly, focal neurological deficit
• Hypertension that is not well controlled by medication
• Positive hepatitis B surface antigen at any time in the past
• History of hepatitis C infection
• Untreated syphilis infection
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2 times the upper limit of normal (ULN).
• Absolute neutrophil count (ANC) less than 740 cells/mm\^3
• Estimated glomerular filtration rate (GFR) less than 50 ml/min within the past 90 days

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (5)

Kenya Med. Research Inst./Walter Reed Project, Clinical Research Centre, Off Hospital Road. Kericho

Kericho, 20200, Kenya

Location

National Institute for Medical Research (NIMR)-Mbeya Medical Research Center (MMRC) Non-Network CRS

Mbeya, Tanzania

Location

SEARCH Thai Red Cross AIDS Research Centre Non-Network CRS

Bangkok, 10330, Thailand

Location

ECHO Center Non-Network CRS

Chon Buri, Thailand

Location

Makerere University Walter Reed Project (MUWRP)

Kampala, Uganda

Location

MeSH Terms

Conditions

HIV Infections

Interventions

VRC01 monoclonal antibody

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Dr. Glenna Schluck
• Organization: Data Coordinating and Analysis Center, HJF Global Infectious Diseases

gschluck@global-id.org

3015003824

Study Officials

• LTC Julie Ake, MD

  U.S. Military HIV Research Program (MHRP)/Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF)

  STUDY CHAIR

• Merlin Robb, MD

  US Military HIV Research Program

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2015
• First Posted: October 29, 2015
• Study Start: April 1, 2016
• Primary Completion: March 15, 2021
• Study Completion: March 15, 2021
• Last Updated: December 17, 2025
• Results First Posted: December 17, 2025

Record last verified: 2025-12

Locations

TA (1); TH (2); UG (1); KE (1)