Very Early Intensive Treatment of HIV-Infected Infants to Achieve HIV Remission

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Sponsor:
Collaborators:
Information provided by (Responsible Party):
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT02140255
First received: May 13, 2014
Last updated: July 9, 2014
Last verified: July 2014

May 13, 2014
July 9, 2014
June 2014
May 2022   (final data collection date for primary outcome measure)
HIV remission [ Time Frame: 48 weeks after ART cessation ] [ Designated as safety issue: No ]
No confirmed HIV RNA at or above the level of detection of the RNA PCR assay
Same as current
Complete list of historical versions of study NCT02140255 on ClinicalTrials.gov Archive Site
Adverse events [ Time Frame: Through 5 years of age ] [ Designated as safety issue: Yes ]
Grade 3, 4, and 5 signs, symptoms, laboratory values, and diagnoses assessed as possibly, probably, or definitely related to one or more ARVs
Same as current
Not Provided
Not Provided
 
Very Early Intensive Treatment of HIV-Infected Infants to Achieve HIV Remission
IMPAACT P1115: Very Early Intensive Treatment of HIV-Infected Infants to Achieve HIV Remission: A Phase I/II Proof of Concept Study

IMPAACT P1115 will explore the effects of early intensive antiretroviral therapy (ART) on achieving HIV remission (HIV RNA below the limit of detection of the assay) among HIV-infected infants.

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.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infection
Drug: Intensive ART regimen
  • Nucleoside reverse transcriptase inhibitor (1) chosen by clinician
  • Nucleoside reverse transcriptase inhibitor (2) chosen by clinician
  • Nevirapine
  • Lopinavir boosted with ritonavir
Early Intensive ART
Intervention: Drug: Intensive ART regimen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
472
May 2022
May 2022   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. 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
  2. COHORT 1 INFANTS

    • ≤ 48 hours of age
    • ≥ 34 weeks gestational age at birth
    • Able to take ARVs by mouth, nasogastric tube, or gastrostomy tube
  3. 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
  4. 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

Exclusion Criteria:

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.
Both
up to 10 Days
No
Contact: Anne Coletti, MS 919-544-7040 ext 11238 acoletti@fhi360.org
United States
 
NCT02140255
IMPAACT P1115, UM1AI068632, UM1AI068616, UM1AI106716
No
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study Chair: Yvonne Bryson, MD University of California, Los Angeles
Study Chair: Ellen Chadwick, MD Northwestern University Feinberg School of Medicine and Ann & Robert Lurie Children's Hospital of Chicago
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP