Nucleoside Reverse Transcriptase Inhibitors (NRTIs) for HIV
Phase-Based Progress Estimates
Effectiveness
Safety
HIV+1 More
Nucleoside Reverse Transcriptase Inhibitors (NRTIs) - DrugEligibility
< 18
All Sexes
What conditions do you have?
Select
Eligibility
< 18
All Sexes
What conditions do you have?
Select
Study Summary
This trial will study whether earlier ART treatment can help HIV-infected infants achieve remission.
Eligible Conditions
- HIV
Treatment Effectiveness
Effectiveness Progress
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
Safety Progress
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 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.
References
- Ruel, Theodore D, Edmund V Capparelli, Camlin Tierney, Bryan S Nelson, Anne Coletti, Yvonne Bryson, Mark F Cotton, et al.. 2021. “Pharmacokinetics and Safety of Early Nevirapine-based Antiretroviral Therapy for Neonates at High Risk for Perinatal HIV Infection: A Phase 1/2 Proof of Concept Study”. The Lancet HIV. Elsevier BV. doi:10.1016/s2352-3018(20)30274-5.
- 2015. "Very Early Intensive Treatment of HIV-Infected Infants to Achieve HIV Remission". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02140255.
Popular Clinical Trials
Top Clinical Trials in Cities
Relevant Clinical Trials
Unbiased Results
We believe in providing patients with all the options.Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.Back to top
Conditions
Cancer Related
Treatments