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Very Early Intensive Treatment of HIV-Infected Infants to Achieve HIV Remission:A Phase I/II Proof of Concept Study (IMPAACT P1115 Version 1.0, dated March 12, 2014)

Description

IMPAACT P1115 will explore the effects of early intensive ART on achieving HIV remission (HIV RNA below the limit of detection of detection of the PCR assay) among infants infected with HIV in utero. Infants in this study will initiate ART within 48 hours of birth and will first be evaluated to determine whether HIV RNA can be detected in their blood while they are on ART. Upon reaching two years of age, infants with undetectable HIV RNA will be evaluated to determine if they meet study criteria to stop taking ART. Infants who meet these criteria will stop taking ART and will be monitored closely to determine whether HIV RNA remains undetectable while they are off ART. For any infant who stops ART and then has HIV RNA detected, ART will be re-started. The study will also assess the safety and pharmacokinetics of early intensive ART in infants.

Phase

N/A

Inclusion and Exclusion Criteria

  • COHORT 1 MOTHERS - Presumed or confirmed HIV infection (if presumed, must be confirmed within 7 days after study entry) - No receipt of ARVs during the current pregnancy. - Willing and able to provide written informed consent for maternal and infant study participation
  • COHORT 1 INFANTS - ≤ 48 hours of age - ≥ 34 weeks gestational age at birth - Able to take ARVs by mouth, nasogastric tube, or gastrostomy tube
  • COHORT 2 MOTHERS - Presumed or confirmed HIV infection (if presumed, must be confirmed within 7 days after study entry) - Willing and able to provide written informed consent for maternal and infant study participation
  • COHORT 2 INFANTS - ≤ 10 days of age - ≥ 34 weeks gestational age at birth - ≥ one nucleic acid test positive for HIV infection on a sample drawn within 48 hours of birth - Started ART within 48 hours of birth on a regimen including 2 NRTIs plus NVP at a dose of at least 8 mg/day for infants weighing ≤ 2 kg or 12 mg/day for infants > 2 kg AND/OR LPV/r - ART regimen was taken daily from date of initiation until study entry - Able to take ARVs by mouth, nasogastric tube, or gastrostomy tube

  • INFANTS
  • Any clinically significant diseases (other than HIV infection) or clinically significant findings during review of medical history or physical examination prior to entry that, in the investigator's opinion, would interfere with study participation or interpretation.

Sites

Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.

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