Health Trials

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

ConditionHIV Infection
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
AgeUp to 48
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Presumed HIV infection defined as at least one positive rapid HIV antibody-based test result from a sample collected in the peripartum period. Presumed infection must be confirmed within 10 business days of enrollment OR

Confirmed HIV infection defined as positive results from two samples collected at different timepoints

Willing and able to provide written informed consent for participation of herself and her infant. The mother must be of legal age or circumstance to provide independent informed consent as determined by site standard operating procedures (SOPs) and consistent with IRB/EC policies and procedures. Otherwise, informed consent must be obtained from a legal guardian and the mother must provide written assent.

Was not previously enrolled in this study with another infant.

Disqualifiers

None

Trial design

Design model

Sequential

Treatments tested in this trial

  • Nucleoside Reverse Transcriptase Inhibitors (NRTIs)

    Drug

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

  • Nevirapine (NVP)

    Drug

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

  • Lopinavir/Ritonavir (LPV/r)

    Drug

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

  • Raltegravir (RAL)

    Drug

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

  • VRC01

    Drug

    40 mg/kg administered subcutaneously.

  • Dolutegravir (DTG)

    Drug

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

  • VRC07-523LS

    Drug

    40 mg/kg administered subcutaneously.

Treatment groups

1,120 Participants
are divided into 9 treatment groups

9

Treatment groups

See each treatment group below.

Group A: Cohort 1, Regimen 1L: 2 NRTIs + NVP + LPV/rExperimental treatment 3 interventions
Group B: Cohort 2, Regimen 1L: 2 NRTIs + NVP + LPV/rExperimental treatment 3 interventions
Group C: Cohort 1, Regimen 2R: 2 NRTIs + NVP + RALExperimental treatment 3 interventions
Group D: Cohort 2, Regimen 2R: 2 NRTIs + NVP + RALExperimental treatment 3 interventions
Group E: Cohort 1, Regimen 2RV: 2 NRTIs + NVP + RAL + VRC01Experimental treatment 4 interventions
Group F: Cohort 1, Regimen 3RD: 2 NRTIs + NVP + RAL switch to 2 NRTIs + DTGExperimental treatment 4 interventions
Group G: Cohort 1, Regimen 3RDV7: 2 NRTIs + NVP + RAL + VRC07-523LS switch to 2 NRTIs + DTG + VRC07-523LSExperimental treatment 5 interventions
Group H: Cohort 1, Regimen 4D: 2 NRTIs + DTGExperimental treatment 2 interventions
Group I: Cohort 1, Regimen 4DV7: 2 NRTIs + DTG + VRC07-523LSExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Number of participants who achieve HIV remission

Defined as no confirmed HIV RNA greater than or equal to the limit of detection (LOD) through 48 weeks of treatment interruption

Time frame
Measured through Week 48

Secondary outcomes

1

Frequency of Grade 3 or higher adverse events possibly, probably or definitely related to any component of the study regimen

Graded according to the DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017

Time frame
Measured through Week 192
2

Number of participants with viral suppression to consistent HIV-1 RNA less than LOD

Based on laboratory evaluations

Time frame
Measured through Week 24
3

Number of participants meeting all eligibility criteria for treatment interruption

As defined in criteria described in study protocol

Time frame
Measured through Week 192
4

Number of infants meeting the selected eligibility criteria for treatment interruption among infants who also met the viral suppression criteria for treatment interruption.

As defined in criteria described in the study protocol

Time frame
Measured through Week 192

Other outcomes

1

Change in HIV-specific immune response

As measured by %CD8+/DR+ T cells

Time frame
Measured through Week 48
2

Change in immune activation markers (%CD8+/DR+ T cells) response

As measured by HIV-specific antibodies and HIV-specific T cell responses

Time frame
Measured through Week 48
3

Change in DTG concentration among treated neonates and young infants

Based on laboratory evaluations

Time frame
Measured through Week 24
4

Change in VRC07-523LS concentration among treated neonates and young infants

Based on laboratory evaluations

Time frame
Measured through Week 24

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Institute of Allergy and Infectious Diseases (NIAID)

Lead sponsor

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

Collaborator

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov
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