Safety and Virologic Effect of a Human Monoclonal Antibody (VRC01) Administered Intravenously to Adults During Early Acute HIV Infection
Condition: HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 1

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.
    

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.
    

Intervention name(s): VRC01; Placebo for VRC01; Antiretroviral therapy (ART) (regimen will vary within countries and by patient)
Intervention type(s): Biological; Biological; Drug
Intervention description(s): 40 mg/kg of VRC01 will be administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump; Administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump; 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.
Other intervention name(s): VRC-HIVMAB060-00-AB
Intervention MeSH terms: Anti-Retroviral Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment