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

NCT02664415 | Completed Phase 2 Results DMC

• 2 other identifiers: RV 39712001
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV Infections

Keywords

Human Monoclonal Antibody

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Serious Adverse Event

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

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

• 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 through 24 weeks after ATI

Secondary Outcomes (10)

• Time to Viral Rebound After Cessation of ART

  Measured from Baseline ATI through ART resumption.

• Level of Rebound Viremia After Cessation of ART

  Measured from Baseline ATI through ART resumption.

• Time to ART Resumption for Any Reason After Cessation of ART

  Measured from Baseline ATI through ART resumption.

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

  Measured from Baseline ATI through ART resumption.

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

  Measured from Baseline ATI through ART resumption

Study Arms (2)

VRC01

EXPERIMENTAL

Participants 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.

Biological: VRC01

Placebo for VRC01

PLACEBO COMPARATOR

Participants 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.

Biological: Placebo for VRC01

Interventions

VRC01 BIOLOGICAL

40 mg/kg; administered IV

Also known as: VRC-HIVMAB060-00-AB

VRC01

Placebo for VRC01 BIOLOGICAL

Sodium Chloride for Injection 0.9%, USP; administered IV

Placebo for VRC01

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

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

Study Sites (1)

SEARCH Thai Red Cross AIDS Research Centre Non-Network CRS

Bangkok, 10330, Thailand

Location

Related Publications (1)

• 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.

  PMID: 31000477 DERIVED

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: Biostatistician
• Organization: MHRP

spinyakorns@hivresearch.org

3015003715

Study Officials

• Trevor Crowell, MD, PhD

  US Military HIV Research Program

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: January 20, 2016
• First Posted: January 27, 2016
• Study Start: August 1, 2016
• Primary Completion: August 4, 2017
• Study Completion: August 4, 2017
• Last Updated: November 2, 2021
• Results First Posted: October 17, 2018

Record last verified: 2021-10

Locations

TH (1)