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Protease Inhibitor

Intensive Antiretroviral Therapy for HIV/AIDS in Infants

Phase 1 & 2
Recruiting
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Mothers will be eligible to enroll with EITHER: Presumed HIV infection defined as greater than or equal to one positive rapid HIV antibody test obtained in the peripartum period. Maternal infection must be confirmed, with confirmatory results available within 10 business days of enrollment. OR Confirmed HIV infection defined as positive results from two samples collected at different time points. All samples tested must be whole blood, serum or plasma. Willing and able to provide written informed consent for participation of herself and her infant. The mother must be of an age to provide legal informed consent as defined by the country in which she resides. If not, informed consent must be obtained from a legal guardian.
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured through week 288
Awards & highlights
No Placebo-Only Group

Study Summary

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

Who is the study for?
This trial is for HIV-infected infants born to mothers with confirmed or presumed HIV. Infants must be less than 48 hours old, at least 36 weeks gestational age, weigh over 2 kg, and able to take oral medication. Mothers should not have received antiretrovirals during pregnancy but may have during labor.Check my eligibility
What is being tested?
The study tests early intensive antiretroviral therapy (ART) in newborns using drugs like Nevirapine, Lopinavir/Ritonavir, Raltegravir, VRC01 and NRTIs to see if it can induce HIV remission—meaning the virus becomes undetectable by standard tests.See study design
What are the potential side effects?
Potential side effects from ART medications include digestive issues, rash or allergic reactions, liver problems and changes in blood sugar or fat levels. In infants specifically, close monitoring is needed due to their developing organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a mother with confirmed or presumed HIV, willing to consent for me and my infant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured through week 288
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured through week 288 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants who achieve HIV remission
Secondary outcome measures
Change in RAL and VRC01 concentrations among treated neonates and young infants
Body Weight Changes
Frequency of Grade 3 or higher adverse events possibly, probably or definitely related to any component of the study regimen
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups
Experimental Treatment
Group I: Cohort 2, Regimen 2R: 2 NRTIs + NVP + RALExperimental Treatment3 Interventions
Participants will receive 2 NRTIs + NVP + RAL.
Group II: Cohort 2, Regimen 1L: 2 NRTIs + NVP + LPV/rExperimental Treatment3 Interventions
Participants will receive 2 NRTIs + NVP + LPV/r.
Group III: Cohort 1, Regimen 2RV: 2 NRTIs + NVP + RAL + VRC01Experimental Treatment4 Interventions
Participants will receive 2 NRTIs + NVP + RAL + VRC01.
Group IV: Cohort 1, Regimen 2R: 2 NRTIs + NVP + RALExperimental Treatment3 Interventions
Participants will receive 2 NRTIs + NVP + RAL.
Group V: Cohort 1, Regimen 1L: 2 NRTIs + NVP + LPV/rExperimental Treatment3 Interventions
Participants will receive 2 NRTIs + NVP + LPV/r.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nevirapine (NVP)
2004
Completed Phase 3
~1920
Lopinavir/Ritonavir (LPV/r)
2012
Completed Phase 3
~230
Raltegravir (RAL)
2002
N/A
~170
VRC01
2016
Completed Phase 2
~5040

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,944 Previous Clinical Trials
2,659,169 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,260 Previous Clinical Trials
5,483,217 Total Patients Enrolled
Ellen Chadwick, MDStudy ChairNorthwestern University Feinberg School of Medicine and Ann & Robert Lurie Children's Hospital of Chicago

Media Library

Lopinavir/Ritonavir (Protease Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02140255 — Phase 1 & 2
HIV/AIDS Research Study Groups: Cohort 2, Regimen 1L: 2 NRTIs + NVP + LPV/r, Cohort 1, Regimen 2R: 2 NRTIs + NVP + RAL, Cohort 2, Regimen 2R: 2 NRTIs + NVP + RAL, Cohort 1, Regimen 1L: 2 NRTIs + NVP + LPV/r, Cohort 1, Regimen 2RV: 2 NRTIs + NVP + RAL + VRC01
HIV/AIDS Clinical Trial 2023: Lopinavir/Ritonavir Highlights & Side Effects. Trial Name: NCT02140255 — Phase 1 & 2
Lopinavir/Ritonavir (Protease Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02140255 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the recruitment stage of this experiment ongoing?

"Affirmative. Clinicaltrials.gov indicates that this trial, which was initially published on January 23rd 2015, is still recruiting participants. Approximately 905 people are required to be recruited from 15 separate sites."

Answered by AI

What pathologies are Nucleoside Reverse Transcriptase Inhibitors (NRTIs) typically employed to address?

"NRTIs, or Nucleoside Reverse Transcriptase Inhibitors, is typically used to prevent occupational exposure to HIV. It also has applications in treating sars-cov-2 positive patients and mild to moderate cases of COVID-19 as well as chronic hepatitis c genotype 1a."

Answered by AI

What additional research has been conducted on Nucleoside Reverse Transcriptase Inhibitors (NRTIs)?

"The first studies on nucleoside reverse transcriptase inhibitors (NRTIs) were conducted at University of Zurich in 2002. Subsequently, there have been 731 completed trials and currently 17 active experiments are running; many taking place within Los Angeles County."

Answered by AI

How many participants is the research team recruiting for this investigation?

"For this clinical trial to reach its desired result, 905 participants who meet the given criteria need to enroll. Those interested in participating can find locations at David Geffen School of Medicine at UCLA NICHD CRS (Los Angeles) and University of California UC San Diego CRS- Mother-Child-Adolescent HIV Program (La Jolla)."

Answered by AI

What is the geographic scope of this clinical investigation?

"To enroll in this medical trial, patients may visit one of 15 different enrolment sites such as David Geffen School of Medicine at UCLA NICHD CRS in Los Angeles or the University of California's UC San Diego CRS- Mother-Child-Adolescent HIV Program. Additionally, Emory University School of Medicine NICHD CRS is another location for recruitment along with 12 other centres."

Answered by AI
~273 spots leftby Jan 2028