Nucleoside Reverse Transcriptase Inhibitors (NRTIs) for HIV

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
HIV+1 More
Nucleoside Reverse Transcriptase Inhibitors (NRTIs) - Drug
Eligibility
< 18
All Sexes
What conditions do you have?
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Study Summary

This trial will study whether earlier ART treatment can help HIV-infected infants achieve remission.

Eligible Conditions
  • HIV

Treatment Effectiveness

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: Measured through Week 288

Measured through Week 24
Number of participants with viral suppression to consistent HIV-1 RNA less than LOD
Measured through Week 288
Frequency of Grade 3 or higher adverse events possibly, probably or definitely related to any component of the study regimen
Number of infants meeting the selected eligibility criteria for ART cessation among infants who also met the viral suppression criteria for ART cessation .
Number of participants meeting all eligibility criteria for ART cessation
Measured through Week 48
Change in RAL and VRC01 concentrations among treated neonates and young infants
Body Weight Changes
Number of participants who achieve HIV remission
Number of participants who experience HIV persistence

Trial Safety

Trial Design

5 Treatment Groups

Cohort 1, Regimen 2R: 2 NRTIs + NVP + RAL
1 of 5
Cohort 2, Regimen 1L: 2 NRTIs + NVP + LPV/r
1 of 5
Cohort 2, Regimen 2R: 2 NRTIs + NVP + RAL
1 of 5
Cohort 1, Regimen 1L: 2 NRTIs + NVP + LPV/r
1 of 5
Cohort 1, Regimen 2RV: 2 NRTIs + NVP + RAL + VRC01
1 of 5
Experimental Treatment

905 Total Participants · 5 Treatment Groups

Primary Treatment: Nucleoside Reverse Transcriptase Inhibitors (NRTIs) · No Placebo Group · Phase 1 & 2

Cohort 1, Regimen 2R: 2 NRTIs + NVP + RALExperimental Group · 3 Interventions: Nevirapine (NVP), Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Raltegravir (RAL) · Intervention Types: Drug, Drug, Drug
Cohort 2, Regimen 1L: 2 NRTIs + NVP + LPV/rExperimental Group · 3 Interventions: Lopinavir/Ritonavir (LPV/r), Nevirapine (NVP), Nucleoside Reverse Transcriptase Inhibitors (NRTIs) · Intervention Types: Drug, Drug, Drug
Cohort 2, Regimen 2R: 2 NRTIs + NVP + RALExperimental Group · 3 Interventions: Nevirapine (NVP), Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Raltegravir (RAL) · Intervention Types: Drug, Drug, Drug
Cohort 1, Regimen 1L: 2 NRTIs + NVP + LPV/rExperimental Group · 3 Interventions: Lopinavir/Ritonavir (LPV/r), Nevirapine (NVP), Nucleoside Reverse Transcriptase Inhibitors (NRTIs) · Intervention Types: Drug, Drug, Drug
Cohort 1, Regimen 2RV: 2 NRTIs + NVP + RAL + VRC01Experimental Group · 4 Interventions: Nevirapine (NVP), VRC01, Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Raltegravir (RAL) · Intervention Types: Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lopinavir
FDA approved
Nevirapine
FDA approved
VRC01
2016
Completed Phase 2
~5040
Raltegravir
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: measured through week 288

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,127 Previous Clinical Trials
5,060,066 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,805 Previous Clinical Trials
2,234,338 Total Patients Enrolled
Yvonne Bryson, MDStudy ChairUniversity of California, Los Angeles
1 Previous Clinical Trials
2 Total Patients Enrolled
Ellen Chadwick, MDStudy ChairNorthwestern University Feinberg School of Medicine and Ann & Robert Lurie Children's Hospital of Chicago

Eligibility Criteria

Age < 18 · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Maternal receipt of ARVs prior to the current pregnancy or during labor and/or the intrapartum period of the current pregnancy is allowed.
Any infant who is born in the United States and meets the eligibility criteria for the CHIP Perinatal Program is automatically enrolled in Cohort 2.
For an individual to be classified as having a presumed or confirmed HIV infection during the peripartum period, they must have a positive rapid HIV antibody test result
It is okay for a pregnant woman to take ARVs (antiretroviral drugs) during her current pregnancy and/or the intrapartum period.
The mother is willing and able to provide written informed consent for participation of herself and her infant
The study groups were comparable with respect to maternal characteristics including age, race, and education
The text states that an infant is eligible and enrolled in Cohort 1 if the infant is born between January 1, 2019 and December 31, 2019.
There is no evidence that the woman received any antiretroviral drugs (ARVs) during her current pregnancy.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 7th, 2021

Last Reviewed: October 4th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.