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Integrase Inhibitor

Dolutegravir for Newborns Exposed to HIV

Phase 1

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

At birth, infant's weight meets specified criteria

At entry, infant is less than or equal to five days of life

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 months

Awards & highlights

Study Summary

This trial will test an anti-HIV drug for newborn babies, up to 108 mother-infant pairs from Brazil, South Africa, Thailand, and the US. Babies will be in the study for 16 weeks, and mothers will exit after the Entry visit.

Who is the study for?

This trial is for newborn babies exposed to HIV-1, born at least 37 weeks into pregnancy and weighing at least 2 kg. They must be generally healthy with normal or slightly altered blood tests. Babies can participate if their mothers have confirmed HIV-1 but haven't taken Dolutegravir close to delivery. Mothers need legal capacity to consent.Check my eligibility

What is being tested?

The study tests the safety and dosage of an anti-HIV drug called Dolutegravir in two forms: oral suspension (0.5 mg/kg) and dispersible tablets (5 mg). It involves up to 108 mother-baby pairs from various countries, monitoring infants for about four months after birth.See study design

What are the potential side effects?

While specific side effects for neonates are being studied, Dolutegravir in adults may cause headache, difficulty sleeping, diarrhea, rash, fatigue, and abnormal dreams. Side effects in babies will be closely monitored due to their vulnerability.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My baby's birth weight was within the required range.

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My baby is 5 days old or younger.

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My infant has started standard HIV prevention treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~28 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

AUC(0-tau) for DTG

Area under the curve (AUC) for DTG

C(last) for DTG

+2 more

Secondary outcome measures

Proportion of infants classified as "study drug-related" safety failures.

Proportion of infants classified as safety failures.

Other outcome measures

Association of UGT1A1 gene sequence variants with DTG CL/F

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort 2Experimental Treatment2 Interventions

Cohort 2, Strata 2A and 2B, will be opened to accrual when the DTG dose and formulation to be administered for each stratum are established based on the PK and safety data from all Cohort 1 strata (Strata 1A and 1B, and 1C if applicable) and available data from other studies. Stratum 2A (DTG-naïve): Infants with no in utero exposure to maternal DTG (no exposure to DTG during the two weeks prior to delivery) Stratum 2B (DTG-exposed): Infants with in utero exposure to maternal DTG (mothers who receive at least one dose of DTG within 72 hours prior to delivery)

Group II: Cohort 1Experimental Treatment2 Interventions

Cohort 1 will be opened first to accrual, with Strata 1A and 1B being opened concurrently, to evaluate the PK and safety of two single DTG liquid suspension doses for the relevant stratum. Stratum 1C will only be opened to accrual if PK and safety data from Strata 1A and 1B infants support administration of DTG 5 mg DT across all neonates, or only in neonates with a minimum birth weight. Stratum 1A (DTG-naïve): Infants with no in utero exposure to maternal DTG (no exposure to DTG during the two weeks prior to delivery) Stratum 1B (DTG-exposed): Infants with in utero exposure to maternal DTG (mothers who receive at least one dose of DTG within 72 hours prior to delivery) Stratum 1C (DTG-naïve): Infants with no in utero exposure to maternal DTG (no exposure to DTG during the two weeks prior to delivery).

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

ViiV HealthcareIndustry Sponsor

360 Previous Clinical Trials

468,543 Total Patients Enrolled

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor

3,270 Previous Clinical Trials

5,485,201 Total Patients Enrolled

National Institute of Mental Health (NIMH)NIH

2,786 Previous Clinical Trials

2,689,663 Total Patients Enrolled

Media Library

Dolutegravir (Integrase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05406583 — Phase 1

HIV/AIDS Research Study Groups: Cohort 1, Cohort 2

HIV/AIDS Clinical Trial 2023: Dolutegravir Highlights & Side Effects. Trial Name: NCT05406583 — Phase 1

Dolutegravir (Integrase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05406583 — Phase 1

Frequently Asked Questions

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

Has the FDA given clearance to Dolutegravir 5 mg Dispersible Tablets?

"Our team has assigned the safety of Dolutegravir 5 mg Dispersible Tablets a rating of 1 due to its Phase 1 status. This means that there is only minimal data indicating efficacy and limited data suggesting safety."

Answered by AI

Are individuals currently being accepted for participation in this experiment?

"Affirmative. The information hosted on clinicaltrials.gov suggests that this medical trial is still in the recruitment phase, having been posted on October 5th 2022 and updated as recently as November 10th 2022. 36 individuals are required for this study, to be located across 8 sites."

Answered by AI

How many locations in the US are presently administering this research?

"At the moment, this clinical trial is actively recruiting patients at 8 centres located throughout America. These places include Emory University School of Medicine NICHD CRS in Atlanta, St. Jude Children's Research Hospital in Memphis and Baylor College of Medicine/ Texas Children's Hospital NICHD CRS among others."

Answered by AI

What is the sample size of participants for this research initiative?

"The total number of study participants necessary to conduct the trial is 36. This research project, sponsored by ViiV Healthcare, will be conducted at Emory University School of Medicine NICHD CRS in Atlanta, Georgia and St. Jude Children's Research Hospital in Memphis Tennessee."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of the Safety, Tolerability, and Pharmacokinetics of Dolutegravir in Neonates Exposed to HIV-1

2022. "A Study of the Safety, Tolerability, and Pharmacokinetics of Dolutegravir in Neonates Exposed to HIV-1". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05406583.