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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02664415
First Posted: January 27, 2016
Last Update Posted: April 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
  Purpose
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.

Condition Intervention Phase
HIV Infections Biological: VRC01 Biological: Placebo for VRC01 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Incidence of serious adverse event at any time up to 10 weeks after the last infusion of VRC01 or placebo [ Time Frame: Measured through Week 34 ]
  • Number of participants with sustained virologic suppression, without indication for ART resumption [ Time Frame: Measured through Week 24 ]
    sustained virologic control (HIV RNA <50 copies/mL)


Secondary Outcome Measures:
  • Time to viral rebound after cessation of ART [ Time Frame: Measured through Week 48 ]
  • Level of rebound viremia after cessation of ART [ Time Frame: Measured through Week 48 ]
  • Time to ART resumption for any reason after cessation of ART [ Time Frame: Measured through Week 48 ]
  • Detectable HIV RNA via single copy assay [ Time Frame: Measured through Week 48 ]
  • CD4+ T cell count [ Time Frame: Measured through Week 48 ]
  • Cell-associated HIV RNA and DNA in the peripheral compartment [ Time Frame: Measured through Week 48 ]
  • Neuropsychological battery performance [ Time Frame: Measured through Week 48 ]
  • Score on the Control and Attention task (i.e., Flanker Task) (computerized test of cognition) [ Time Frame: Measured through Week 48 ]
  • Frequency of hospitalization [ Time Frame: Measured through Week 48 ]
  • Incidence of non-AIDS related conditions [ Time Frame: Measured through Week 48 ]

Estimated Enrollment: 24
Study Start Date: August 2016
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VRC01
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
40 mg/kg; administered IV
Other Name: VRC-HIVMAB060-00-AB
Placebo Comparator: Placebo for VRC01
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
Sodium Chloride for Injection 0.9%, USP; administered IV

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02664415


Locations
Thailand
SEARCH Thai Red Cross AIDS Research Centre Non-Network CRS
Bangkok, Thailand, 10330
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Study Chair: Jintanat Ananworanich, MD, PhD US Military HIV Research Program
  More Information

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT02664415     History of Changes
Other Study ID Numbers: RV 397
12001 ( Registry Identifier: DAIDS-ES Registry Number )
First Submitted: January 20, 2016
First Posted: January 27, 2016
Last Update Posted: April 25, 2017
Last Verified: April 2017

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Human Monoclonal Antibody

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs


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