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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

Must not have

History of any lymphoproliferative disorder

History of active malignancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured through week 192

Awards & highlights

No Placebo-Only Group

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.

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.

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

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I am a mother with confirmed or presumed HIV, willing to consent for me and my infant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a condition where my lymphocytes grow abnormally.

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I have a history of cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured through week 192

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured through week 192

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured through week 192 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants who achieve HIV remission

Secondary study objectives

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 treatment interruption among infants who also met the viral suppression criteria for treatment interruption.

Number of participants meeting all eligibility criteria for treatment interruption

+2 more

Other study objectives

Change in DTG concentration among treated neonates and young infants

Change in HIV-specific immune response

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

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

7Treatment 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 3RDV7: 2 NRTIs + NVP + RAL + VRC07-523LS switch to 2 NRTIs + DTG + VRC07-523LSExperimental Treatment4 Interventions

Participants will receive 2 NRTIs + NVP + RAL + VRC07-523LS with subsequent switch to 2 NRTIs + DTG + VRC07-523LS upon reaching 28 days of age and 3 kg body weight.

Group IV: Cohort 1, Regimen 3RD: 2 NRTIs + NVP + RAL switch to 2 NRTIs + DTGExperimental Treatment4 Interventions

Participants will receive 2 NRTIs + NVP + RAL with subsequent switch to 2 NRTIs + DTG upon reaching 28 days of age and 3 kg body weight.

Group V: Cohort 1, Regimen 2RV: 2 NRTIs + NVP + RAL + VRC01Experimental Treatment4 Interventions

Participants will receive 2 NRTIs + NVP + RAL + VRC01.

Group VI: Cohort 1, Regimen 2R: 2 NRTIs + NVP + RALExperimental Treatment3 Interventions

Participants will receive 2 NRTIs + NVP + RAL.

Group VII: 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