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
  Purpose

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.


Condition Intervention Phase
HIV Infection
Drug: Intensive ART regimen
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: IMPAACT P1115: Very Early Intensive Treatment of HIV-Infected Infants to Achieve HIV Remission: A Phase I/II Proof of Concept Study

Resource links provided by NLM:


Further study details as provided by International Maternal Pediatric Adolescent AIDS Clinical Trials Group:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 472
Study Start Date: June 2014
Estimated Study Completion Date: May 2022
Estimated Primary Completion Date: May 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Early Intensive ART 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

Detailed 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.

  Eligibility

Ages Eligible for Study:   up to 10 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02140255

Contacts
Contact: Anne Coletti, MS 919-544-7040 ext 11238 acoletti@fhi360.org

Locations
United States, Florida
University of Florida Center for HIV/AIDS Research, Education, and Service Recruiting
Jacksonville, Florida, United States, 32209
Principal Investigator: Mobeen Rathore, MD         
Sponsors and Collaborators
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT02140255     History of Changes
Other Study ID Numbers: IMPAACT P1115, UM1AI068632, UM1AI068616, UM1AI106716
Study First Received: May 13, 2014
Last Updated: July 9, 2014
Health Authority: United States: Federal Government

Keywords provided by International Maternal Pediatric Adolescent AIDS Clinical Trials Group:
HIV Remission
HIV Cure

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014