Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission

Summary

The study will explore the effects of early intensive antiretroviral therapy (ART) with or without a broadly neutralizing antibody (bNAb) on achieving HIV remission (HIV RNA below the limit of detection of the assay) among infants living with HIV.

Conditions

• HIV Infection

Interventions

DRUG

Nucleoside Reverse Transcriptase Inhibitors (NRTIs)

Chosen by the site investigator and dosed according to World Health Organization (WHO) or individual country or local standard guidelines.

DRUG

Nevirapine (NVP)

Administered orally. Dosed according to study step/participant's age/participant's weight.

DRUG

Lopinavir/Ritonavir (LPV/r)

Administered orally. Dosed according to study step and participant's age.

DRUG

Raltegravir (RAL)

Administered orally. Dosed according to study step and participant's age.

DRUG

VRC01

40 mg/kg administered subcutaneously.

DRUG

Dolutegravir (DTG)

Dosed according to study step/participant's age/participant's weight

DRUG

VRC07-523LS

40 mg/kg administered subcutaneously.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• National Institute of Mental Health (NIMH)

  collaborator NIH

• National Institute of Allergy and Infectious Diseases (NIAID)

  lead NIH

Principal Investigators

• Ellen Chadwick, MD · Northwestern University Feinberg School of Medicine and Ann & Robert Lurie Children's Hospital of Chicago

• Jennifer Jao, MD · Northwestern University Feinberg School of Medicine and Ann & Robert Lurie Children's Hospital of Chicago

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Max Age

48 Hours

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-01-23

Primary Completion

2028-01-31

Completion

2031-12-31

FDA Drug

Yes

Countries

• United States
• Argentina
• Brazil
• Haiti
• Kenya
• Malawi
• Puerto Rico
• South Africa
• Tanzania
• Thailand
• Uganda
• Zambia
• Zimbabwe

Study Locations