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HIV InfectionsPhase 1NCT02591420

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

A Phase 1 study testing VRC01 and Antiretroviral therapy (ART) (regimen will vary within countries and by patient) in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites in 4 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 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. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
HIV Infections
What is being tested?
VRC01 and Antiretroviral therapy (ART) (regimen will vary within countries and by patient)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
5 sitesin 4 countries
Study dates
Apr 2016to 15 Mar 2021
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Able and willing to complete the informed consent process
  • Passes Test of Understanding
  • 18 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
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  • 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

Who cannot join

  • 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
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  • 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
  • Breastfeeding
  • Pregnancy
  • Receipt of licensed vaccine or other investigational study agent within 28 days prior to enrollment or past participation in an investigational HIV vaccine study with receipt of active product
  • Current or planned participation in another interventional clinical trial during the study period
  • Chronic or recurrent use of medications that modify host immune response, e.g., oral or parenteral steroids, cancer chemotherapy
  • Any other chronic or clinically significant medical condition that in the opinion of investigator would jeopardize the safety or rights of the volunteer. Including, but not limited to: diabetes mellitus type I, chronic hepatitis, renal failure; OR clinically significant forms of: drug or alcohol abuse, mental illness, severe asthma, autoimmune disease, psychiatric disorders, heart disease, or cancer.
  • Study site employee

Trial locations and contacts

5 sites in 4 countries.

5 sites in 4 countries

Thailand2 sites

  • SEARCH Thai Red Cross AIDS Research Centre Non-Network CRS

    Bangkok, 10330

  • ECHO Center Non-Network CRS

    Chon Buri

Other trials in Thailand

Kenya1 site

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

    Kericho, 20200

Other trials in Kenya

Tanzania1 site

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

    Mbeya

Other trials in Tanzania

Uganda1 site

  • Makerere University Walter Reed Project (MUWRP)

    Kampala

Other trials in Uganda

About this study

Official title: Safety and Virologic Effect of a Human Monoclonal Antibody, VRC-HIVMAB060-00-AB (VRC01), With Broad HIV-1 Neutralizing Activity, Administered Intravenously to Adults During Early Acute HIV Infection

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.

Read the detailed description

Human monoclonal antibodies (mAbs) may have the potential to treat HIV infection by preventing the spread of the virus. This study will evaluate an experimental mAB known as VRC-HIVMAB060-00-AB (VRC01). The purpose of this study is to evaluate the safety and virologic effect of VRC01, alone or in combination with ART, in adults with early acute HIV infection. Researchers will also evaluate the effect of VRC01 on the establishment of an HIV reservoir during early acute HIV infection.

This study will enroll participants who are diagnosed with early acute HIV infection. Participants will be randomly assigned to one of three groups: Group 1 will begin ART and receive a single infusion of placebo at Day 0. Group 2 will begin ART and receive a single infusion of VRC01 at Day 0. Group 3 will receive a single infusion of VRC01 on Day 0 and begin ART on Day 7. ART will vary by country and will consist of country guideline-recommended, available first line 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.

Study visits will occur at Days 0, 1, 3, 7, 10, 14, 18, 21, 25, 28, 42, 56, 84, 112, 168, and 175. Visits will include a physical examination, medical history review, and blood collection. Neurocognitive testing will take place on Day 168. Some participants may take part in optional study procedures at various time points during the study including mucosal secretion collection, rectosigmoid biopsy, lymph node biopsy, leukapheresis, and lumbar puncture.

Conditions
HIV Infections
Being tested
VRC01, Placebo for VRC01, Antiretroviral therapy (ART) (regimen will vary within countries and by patient)
Medical subject headings
HIV Infections

What participants receive

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

  • VRC01Biological

    Also called VRC-HIVMAB060-00-AB

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

  • Placebo for VRC01Biological

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

  • 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.

Study groups in NCT02591420
Study groupRoleWhat they receive
Group 1: immediate ART and placebo infusionExperimentalParticipants will start ART and will receive a single infusion of placebo at Day 0.
Receives: Biological: Placebo for VRC01; Drug: Antiretroviral therapy (ART) (regimen will vary within countries and by patient)
Group 2: immediate ART and VRC01 infusionExperimentalParticipants will start ART and receive a single infusion of VRC01 at Day 0.
Receives: Biological: VRC01; Drug: Antiretroviral therapy (ART) (regimen will vary within countries and by patient)
Group 3: immediate VRC01 infusion and subsequent ARTExperimentalParticipants will receive a single infusion of VRC01 on Day 0 followed by ART initiation on Day 7.
Receives: Biological: VRC01; Drug: Antiretroviral therapy (ART) (regimen will vary within countries and by patient)

What is being measured

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

  1. 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: Measured through Week 24

  2. Plasma Viral Load Change From Day 0 to Day 7

    Measured: Measured through Day 7

Secondary outcomes (10)

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

    Measured: Measured through Week 24

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

    Measured: Measured through Week 24

  3. Measurement of Plasma Viremia Including Single Copy HIV RNA Quantification

    In samples with HIV RNA less than 50 copies/ml at Day 7, Day 14, and Week 24

    Measured: Measured through Week 24

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

    Measured: Measured through Week 24 (Day 168)

  5. Percentage of Participants Experiencing Acute Retroviral Syndrome

    Measured: Measured through Week 24

  6. Percentage of Participants Experiencing a Hospitalization

    Measured: Measured through Week 24

  7. Percentage of Participants Experiencing Opportunistic Infections

    Measured: Measured through Week 24

  8. Percentage of Participants Experiencing Non-AIDS-related Conditions

    Measured: Measured through Week 24

  9. Measurement of CD4 + T Cells

    Decrease from baseline to nadir, increase from nadir to Week 24, and overall change from baseline to Week 24

    Measured: Measured through Week 24

  10. Measurement of VRC01 Levels in Peripheral Blood

    Measured: Measured through Week 24

Timeline

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

  1. First posted29 Oct 2015 (estimated)
  2. Study startApr 2016
  3. Primary completion15 Mar 2021
  4. Study completion15 Mar 2021

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02591420
Sponsor's protocol ID
RV 398
Other IDs
12002, WRAIR 2166
Status last verified
Jul 2026
First submitted
28 Oct 2015
Last updated
23 Jul 2026
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VRC01 and Antiretroviral therapy (ART) (regimen will vary within countries and by patient) in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites in 4 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 12 inclusion and 22 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 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Thailand, Kenya, Tanzania, Uganda. 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?

Yes. Results are posted in the registry (first posted 17 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Grade 3 or Greater mAb-related Reactogenicity and mAb-related Adverse Events (AEs) (time frame: Measured through Week 24). The study lists 2 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 NCT02591420.

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 23 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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