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HIV InfectionsPhase 2NCT02664415

Safety and Therapeutic Efficacy of the VRC01 Antibody in Patients Who Initiated Antiretroviral Therapy During Early Acute HIV Infection

A Phase 2 study testing VRC01 in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Thailand.

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

The study will evaluate the safety and therapeutic efficacy of the human monoclonal antibody (mAb) VRC-HIVMAB060-00-AB (VRC01), when administered during analytic treatment interruption (ATI), in adults who began antiretroviral therapy (ART) during early acute HIV infection. Read more about this study

Who is it for?
Ages 20 to 50 years
Conditions the study is for
HIV Infections
What is being tested?
VRC01
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
23 participants
Where
1 siteThailand
Study dates
Aug 2016to 4 Aug 2017
Phase
Phase 2
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 20 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Able and willing to provide written informed consent or, in the case of illiteracy, witnessed verbal informed consent with documentation of a thumbprint in lieu of a signature.
  • Passes Test of Understanding.
  • Man or woman aged 20-50 years.
  • Initiated on ART during acute HIV infection (Fiebig Stage I to III at RV 254 enrollment).
  • Prescribed ART for at least 24 months prior to enrollment.
  • HIV-1 RNA less than 50 copies/mL on at least three consecutive measurements within the past 12 months.
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  • Integrated HIV DNA in peripheral blood mononuclear cells (PBMCs) below the level of detection (1 copy/10^5 PBMCs) within 6 months prior to enrollment.
  • Last documented peripheral blood CD4 greater than 400 cells/mm^3 within 3 months prior to enrollment.
  • No HIV-related or AIDS-defining illness within 6 months prior to enrollment.
  • In general good health.
  • Able to participate in study visits.
  • 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-human chorionic gonadotropin (β-HCG) 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

  • Previous receipt of humanized or human monoclonal antibody whether licensed or investigational.
  • Ongoing AIDS-related opportunistic infection (including oral thrush).
  • 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 requiring daily treatment.
  • Physical finding on examination considered indicative of significant disease such as murmur (other than functional), hepatosplenomegaly, or focal neurologic deficit.
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  • Hypertension that is not well controlled by medication.
  • Hepatitis B surface antigen positive at any time in the past.
  • Hepatitis C antibody positive at any time in the past.
  • Untreated syphilis.
  • Estimated glomerular filtration rate (GFR) less than 50 ml/min within the past 90 days.
  • Pregnant or breastfeeding.
  • 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

1 site in 1 country.

Thailand1 site

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

    Bangkok, 10330

Other trials in Thailand

About this study

Official title: Safety and Therapeutic Efficacy of the Broadly Neutralizing HIV-1 Specific Monoclonal Antibody VRC01 During Analytic Treatment Interruption in Patients Who Initiated Antiretroviral Therapy During Early Acute HIV Infection

The study will evaluate the safety and therapeutic efficacy of the human monoclonal antibody (mAb) VRC-HIVMAB060-00-AB (VRC01), when administered during analytic treatment interruption (ATI), in adults who began antiretroviral therapy (ART) 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 therapeutic efficacy of VRC01, when administered during analytic treatment interruption (ATI), in adults who began antiretroviral therapy (ART) during early acute HIV infection.

The study will enroll participants from the RV 254 study who were diagnosed during early acute HIV infection and who have been on ART. At study entry, participants will stop taking their antiretroviral (ARV) medications. They will be randomly assigned to receive an intravenous (IV) infusion of VRC01 or placebo at Weeks 0 (study entry), 3, 6, 9, 12, 15, 18, 21, and 24. For 7 days following each infusion, participants will be asked to record and report any symptoms to study researchers.

In addition to the infusion visits, participants will attend follow-up visits for 48 weeks. Study visits may include physical examinations, blood collection, and urine collection. Neurocognitive testing will take place at select study visits. Some participants may take part in optional study procedures including mucosal secretion collection, MRI brain scan, colon biopsy, lymph node biopsy, leukapheresis, and lumbar puncture.

Study staff will monitor participants' HIV throughout the study, and participants will end their participation in the study and restart their ARV medications, if needed.

Conditions
HIV Infections
Being tested
VRC01, Placebo for VRC01
Keywords
Human Monoclonal Antibody
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; administered IV

  • Placebo for VRC01Biological

    Sodium Chloride for Injection 0.9%, USP; administered IV

Study groups in NCT02664415
Study groupRoleWhat they receive
VRC01ExperimentalParticipants will receive an intravenous (IV) infusion of 40 mg/kg of VRC01 at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met.
Receives: Biological: VRC01
Placebo for VRC01Placebo comparatorParticipants will receive an IV infusion of placebo at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met.
Receives: Biological: Placebo for VRC01

What is being measured

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

  1. Number of Participants With Serious Adverse Event

    Participants were monitored for up to 10 weeks after the last infusion of VRC01 or placebo

    Measured: Measured up to 10 weeks after last infusion of VRC01 or placebo

  2. Number of Participants With Sustained Virologic Suppression

    Number of participants who sustained virologic control (HIV RNA <50 copies/mL), without indication for ART resumption at week 24.

    Measured: Measured through 24 weeks after ATI

Secondary outcomes (10)

  1. Time to Viral Rebound After Cessation of ART

    This is the days from Analytic Treatment Interruption (ATI) to:

    1. HIV RNA >= 20 copies/mL.
    2. HIV RNA >= 1000 copies/mL

    Measured: Measured from Baseline ATI through ART resumption.

  2. Level of Rebound Viremia After Cessation of ART

    This is the HIV-1 RNA levels (copies/mL) at first detection and ART resumption.

    Measured: Measured from Baseline ATI through ART resumption.

  3. Time to ART Resumption for Any Reason After Cessation of ART

    This is the days from ATI to ART resumptions.

    Measured: Measured from Baseline ATI through ART resumption.

  4. Number of Participants With Detectable HIV-1 RNA Via Single Copy Assay

    This is number of participants who had detectable HIV-1 RNA via the ultrasensitive single copy assay prior to detectability on the routine assay.

    Measured: Measured from Baseline ATI through ART resumption.

  5. Change in CD4+ T Cell Count From ATI to ART Resumption

    This is change in CD4+ T cell count from ATI to ART resumption.

    Measured: Measured from Baseline ATI through ART resumption

  6. Total HIV DNA in the Peripheral Compartment

    This is total HIV DNA levels at baseline ATI, ART resumption and 6 month after ART resumption

    Measured: Measured from ATI through 6 months after ART resumption

  7. Number of Participants Hospitalized.

    Participants were monitored for up to 10 weeks after the last infusion of VRC01 or placebo

    Measured: Measured up to 10 weeks after the last infusion of VRC01 or placebo

  8. Number of Participants With Acute Retroviral Syndrome (ARS)

    This is the number of participants who have developed during ATI.

    Measured: Measured from Baseline ATI through ART resumption.

  9. Neuropsychological Battery Performance

    This is a NPZ-4 score,a 4-test NP battery evaluated fine motor function/manual dexterity [Grooved Pegboard test (GP), non-dominant hand], psychomotor speed [Color Trails 1 (CT1), Trail Making A (TM)], and executive function/set shifting [Color Trails 2 (CT2)]. Individual test raw scores were converted to z-scores. Z-scores range from -3 standard deviations up to +3 standard deviations. Higher scores indicate better test performance and lower cognitive impairment.

    Measured: Measured from Baseline ATI through ART resumption.

  10. Computed Score on the Control and Attention Task (i.e., Flanker Task)

    The Flanker is a measure of executive function, specifically tapping inhibitory control and attention.The scores range from 0 to 10. A higher scores indicate higher levels of ability to attend to relevant stimuli and inhibit attention from irrelevant stimuli.

    Measured: Measured from Baseline ATI through ART resumption.

Timeline

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

  1. First posted27 Jan 2016 (estimated)
  2. Study startAug 2016
  3. Primary completion4 Aug 2017
  4. Study completion4 Aug 2017

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02664415
Sponsor's protocol ID
RV 397
Other IDs
12001
Status last verified
Oct 2021
First submitted
20 Jan 2016
Last updated
2 Nov 2021
Data monitoring committee
Yes

Publications

  • Crowell TA, Colby DJ, Pinyakorn S, Sacdalan C, Pagliuzza A, Intasan J, Benjapornpong K, Tangnaree K, Chomchey N, Kroon E, de Souza MS, Tovanabutra S, Rolland M, Eller MA, Paquin-Proulx D, Bolton DL, Tokarev A, Thomas R, Takata H, Trautmann L, Krebs SJ, Modjarrad K, McDermott AB, Bailer RT, Doria-Rose N, Patel B, Gorelick RJ, Fullmer BA, Schuetz A, Grandin PV, O'Connell RJ, Ledgerwood JE, Graham BS, Tressler R, Mascola JR, Chomont N, Michael NL, Robb ML, Phanuphak N, Ananworanich J; RV397 Study Group. Safety and efficacy of VRC01 broadly neutralising antibodies in adults with acutely treated HIV (RV397): a phase 2, randomised, double-blind, placebo-controlled trial. Lancet HIV. 2019 May;6(5):e297-e306. doi: 10.1016/S2352-3018(19)30053-0. Epub 2019 Apr 15.

    PubMed 31000477

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing VRC01 in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Thailand.

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 17 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 2 Nov 2021. 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 Thailand. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Oct 2018). 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 Serious Adverse Event (time frame: Measured up to 10 weeks after last infusion of VRC01 or placebo). 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 NCT02664415, which also lists 1 linked publication.

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 2 Nov 2021; AzTrials last refreshed its copy on 8 Nov 2026.

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