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Source study found

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Clinical trial establishes effective HIV dosing regimen for full-term newborns (opens in a new tab)

news-medical.net · 2026-10-22

Short answerEvidenceSource

Short answer

Not assessed

Check incomplete.

We found a likely source study, but its evidence could not be prepared for claim review. The article's claims remain unverified.

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NewsLink checks it

Source study identified.

A source study was identified, but the study's evidence could not be prepared for claim assessment. No claim verdicts are available.

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3

The source study

Pharmacokinetics and safety of dolutegravir in term neonates exposed to HIV-1 (IMPAACT 2023): a phase 1, open-label, multicentre study

The Lancet HIV · 2026
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Then inspect each claim

Evidence layer

Claim by claim

A source study was identified, but the study's evidence could not be prepared for claim assessment. The claims below have not been assessed.

Claim 1 of 5Not checkedAn international IMPAACT Network study helped inform the FDA's recent approval of dolutegravir for HIV-1 treatment in newborns from birth.View evidenceHide evidence

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A source study was identified, but the evidence comparison for this claim was not completed. No verdict has been assigned.

Claim 2 of 5Not checkedThe study, published in The Lancet HIV, identified a dosing regimen that achieves appropriate drug levels in full-term newborns and supports use of dolutegravir from the first days of life.View evidenceHide evidence

Not checked

A source study was identified, but the evidence comparison for this claim was not completed. No verdict has been assigned.

Claim 3 of 5Not checkedThe study, IMPAACT 2023, was a Phase I clinical trial conducted across sites in South Africa, Thailand and the United States, enrolling 48 full-term newborns born to women living with HIV-1 and following infants for 16 weeks to assess safety.View evidenceHide evidence

As stated48 newborns; 16 weeks follow-up

Not checked

A source study was identified, but the evidence comparison for this claim was not completed. No verdict has been assigned.

Claim 4 of 5Not checkedResearchers found that dolutegravir achieved levels in newborns comparable to those seen in older children and adults, and that it was generally well tolerated with a safety profile similar to that seen in older infants and children.View evidenceHide evidence

Not checked

A source study was identified, but the evidence comparison for this claim was not completed. No verdict has been assigned.

Claim 5 of 5Not checkedThe FDA approval announced in August 2026 extends dolutegravir's label to treat HIV-1 infection in full-term infants weighing at least two kilograms from birth up to four weeks of age, in combination with other antiretroviral medications.View evidenceHide evidence

As statedbirth to 4 weeks; at least 2 kilograms

Not checked

A source study was identified, but the evidence comparison for this claim was not completed. No verdict has been assigned.

Finally, the search trail

Method layer

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Pharmacokinetics and safety of dolutegravir in term neonates exposed to HIV-1 (IMPAACT 2023): a phase 1, open-label, multicentre study

The Lancet HIV · 2026

Source record (opens in a new tab)

Why this one

Near certain

NewsLink found the paper. Tessa is where you inspect it deeply.

Papers considered

The selected paper, plus nearby candidates.

Crossref, PubMed, Europe PMC · 40 candidate papers

Selected

Pharmacokinetics and safety of dolutegravir in term neonates exposed to HIV-1 (IMPAACT 2023): a phase 1, open-label, multicentre study

The Lancet HIV · 2026 · Crossref

Source (opens in a new tab)

And 34 more candidates considered.