Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission

Part of paid clinical trials in La Jolla, California.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT02140255
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - 48 Hours
Healthy Volunteers
Not accepted

Interventions

  • Nucleoside Reverse Transcriptase Inhibitors (NRTIs) — DRUG
    Chosen by the site investigator and dosed according to World Health Organization (WHO) or individual country or local standard guidelines.
  • Nevirapine (NVP) — DRUG
    Administered orally. Dosed according to study step/participant's age/participant's weight.
  • Lopinavir/Ritonavir (LPV/r) — DRUG
    Administered orally. Dosed according to study step and participant's age.
  • Raltegravir (RAL) — DRUG
    Administered orally. Dosed according to study step and participant's age.
  • VRC01 — DRUG
    40 mg/kg administered subcutaneously.
  • Dolutegravir (DTG) — DRUG
    Dosed according to study step/participant's age/participant's weight
  • VRC07-523LS — DRUG
    40 mg/kg administered subcutaneously.

Study Details

The study will explore the effects of early intensive antiretroviral therapy (ART) with or without a broadly neutralizing antibody (bNAb) on achieving HIV remission (HIV RNA below the limit of detection of the assay) among infants living with HIV.

Key Dates

Start date
Jan 23, 2015
Status verified
May 2026
Primary completion
Jan 31, 2028
Completion
Dec 31, 2031

Study Design

Enrollment
1,120 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1, Regimen 1L: 2 NRTIs + NVP + LPV/r
    Participants will receive 2 NRTIs + NVP + LPV/r.
  • Experimental: Cohort 2, Regimen 1L: 2 NRTIs + NVP + LPV/r
    Participants will receive 2 NRTIs + NVP + LPV/r.
  • Experimental: Cohort 1, Regimen 2R: 2 NRTIs + NVP + RAL
    Participants will receive 2 NRTIs + NVP + RAL.
  • Experimental: Cohort 2, Regimen 2R: 2 NRTIs + NVP + RAL
    Participants will receive 2 NRTIs + NVP + RAL.
  • Experimental: Cohort 1, Regimen 2RV: 2 NRTIs + NVP + RAL + VRC01
    Participants will receive 2 NRTIs + NVP + RAL + VRC01.
  • Experimental: Cohort 1, Regimen 3RD: 2 NRTIs + NVP + RAL switch to 2 NRTIs + DTG
    Participants will receive 2 NRTIs + NVP + RAL with subsequent switch to 2 NRTIs + DTG upon reaching 28 days of age and 3 kg body weight.
  • Experimental: Cohort 1, Regimen 3RDV7: 2 NRTIs + NVP + RAL + VRC07-523LS switch to 2 NRTIs + DTG + VRC07-523LS
    Participants will receive 2 NRTIs + NVP + RAL + VRC07-523LS with subsequent switch to 2 NRTIs + DTG + VRC07-523LS upon reaching 28 days of age and 3 kg body weight.
  • Experimental: Cohort 1, Regimen 4D: 2 NRTIs + DTG
    Participants will receive 2 NRTIs + DTG
  • Experimental: Cohort 1, Regimen 4DV7: 2 NRTIs + DTG + VRC07-523LS
    Participants will receive 2 NRTIs + DTG + VRC07-523LS

Primary Outcome Measure

Number of participants who achieve HIV remission [ Time Frame: Measured through Week 48 ]

Central Contacts

Locations (20)

FacilityCityStateZIPSite coordinators
4601, University of California, San Diego Clinical Research SiteLa JollaCalifornia92093-0672-
5048, University of Southern California Clinical Research SiteLos AngelesCalifornia90089
Yvonne A. Morales
[email protected]
323-865-1561
5112, David Geffen School of Medicine at UCLA Clinical Research SiteLos AngelesCalifornia90095-1752
Margaret F. Bradley
[email protected]
310-206-3895
5052, University of Colorado, Denver Clinical Research SiteAuroraColorado80045
Carrie Chambers, RN
[email protected]
720-777-4424
5055, South Florida CDTC Fort Lauderdale Clinical Research SiteFort LauderdaleFlorida33316-
5051, University of Florida Center for HIV/AIDS Research, Education and Service (UF CARES) Clinical Research SiteJacksonvilleFlorida32209
Saniyyah Mahmoudi, A.R.N.P.
[email protected]
904-244-5331
5127, Pediatric Perinatal HIV Clinical Research SiteMiamiFlorida33136
Nicolette Gomez
[email protected]
305-243-4447
Emory University School of Medicine NICHD CRSAtlantaGeorgia30322-
4001, Lurie Children's Hospital of Chicago Clinical Research SiteChicagoIllinois60614-3393
Lela Lartey
[email protected]
312-227-6280
5083, Rush University Cook County Hospital Clinical Research SiteChicagoIllinois60612
Maureen McNichols, R.N., M.S.N., C.C.R.C.
[email protected]
847-501-0243
5092, Johns Hopkins Clinical Research SiteBaltimoreMaryland21287
Amanda Haines
[email protected]
443-287-8888
Boston Medical Center Ped. HIV Program NICHD CRSBostonMassachusetts02118-
5040, SUNY Stony Brook Clinical Research SiteStony BrookNew York11794-
5013, Jacobi Medical Center Clinical Research SiteThe BronxNew York10461
Marlene Burey, R.N., M.S.N., P.N.P.
[email protected]
1-718-918-4783
5114, Bronx Lebanon Hospital Center Clinical Research SiteThe BronxNew York10457
Martha Cavallo, A.N.P., C.R.N.P.
[email protected]
1-718-960-1010
Philadelphia IMPAACT Unit CRSPhiladelphiaPennsylvania9104-
6501, St Jude Children's Research Hospital Clinical Research SiteMemphisTennessee38105-3678
Julie Maier
[email protected]
901-595-3078
5128, Baylor College of Medicine/Texas Children's Hospital Clinical Research SiteHoustonTexas77030
Alejandra Martinez
[email protected]
832-824-1443
Seattle Children's Research Institute CRSSeattleWashington98101-
Univ. of Washington NICHD CRSSeattleWashington98195-

Find similar trials in La Jolla, CA

By condition
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By specialty
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By research site
4601, University of California, San Diego Clinical Research Site· La Jolla, CA5048, University of Southern California Clinical Research Site· Los Angeles, CA5112, David Geffen School of Medicine at UCLA Clinical Research Site· Los Angeles, CA5052, University of Colorado, Denver Clinical Research Site· Aurora, CO5055, South Florida CDTC Fort Lauderdale Clinical Research Site· Fort Lauderdale, FL5051, University of Florida Center for HIV/AIDS Research, Education and Service (UF CARES) Clinical Research Site· Jacksonville, FL

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