Clinical Trials

MainTitle

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

This study is currently recruiting participants. (see Contacts and Locations)

Verified March 2019 by National Institute of Allergy and Infectious Diseases (NIAID)

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Information provided by (Responsible Party)
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier
NCT02140255

First received: May 13, 2014
Last updated: March 29, 2019
Last Verified: March 2019
History of Changes
Purpose

Purpose

The study 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 : Nucleoside Reverse Transcriptase Inhibitors (NRTIs)
Drug : Nevirapine (NVP)
Drug : Lopinavir/Ritonavir (LPV/r)
Drug : Raltegravir (RAL)
Drug : VRC01
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Very Early Intensive Treatment of HIV-Infected Infants to Achieve HIV Remission: A Phase I/II Proof of Concept Study

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures

  • Number of participants who achieve HIV remission [ Time Frame: Measured through Week 48 ]
    Defined as no confirmed HIV RNA greater than or equal to the limit of detection (LOD) through 48 weeks of ART cessation
Secondary Outcome Measures:
  • Frequency of Grade 3 or higher adverse events possibly, probably or definitely related to any component of the study regimen [ Time Frame: Measured through Week 192 ]
    Graded according to the DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017
  • Number of participants with viral suppression to consistent HIV-1 RNA less than LOD [ Time Frame: Measured through Week 24 ]
    Based on laboratory evaluations
  • Number of participants meeting all eligibility criteria for ART cessation [ Time Frame: Measured through Week 192 ]
    As defined in criteria described in study protocol
  • Number of infants meeting the selected eligibility criteria for ART cessation among infants who also met the viral suppression criteria for ART cessation . [ Time Frame: Measured through Week 192 ]
    As defined in criteria described in the study protocol
  • Number of participants who experience HIV persistence [ Time Frame: Measured through Week 48 ]
    As measured by plasma viremia (single copy), droplet digital DNA, replication competent HIV reservoirs
  • Changes in immune activation markers (%CD8+/DR+ T cells) and HIV-specific immune responses [ Time Frame: Measured through Week 48 ]
    As measured by HIV-specific antibodies and HIV-specific T cell responses
  • Change in RAL and VRC01 concentrations among treated neonates and young infants [ Time Frame: Measured through Week 48 ]
    Based on laboratory evaluations

Estimated Enrollment: 905
Study Start Date: January 2015
Estimated Study Completion Date: April 1, 2022
Estimated Primary Completion Date: April 1, 2022 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Cohort 1, Regimen 1L: 2 NRTIs + NVP + LPV/r
Participants will receive 2 NRTIs + NVP + LPV/r.
Drug: Nucleoside Reverse Transcriptase Inhibitors (NRTIs)

Chosen by the site investigator and dosed according to World Health Organization (WHO) or individual country or local standard guidelines.

Drug: Nevirapine (NVP)

Administered orally. Dosed according to study step/participant's age/participant's weight.

Drug: Lopinavir/Ritonavir (LPV/r)

Administered orally. Dosed according to study step and participant's age.

Experimental: Cohort 2, Regimen 1L: 2 NRTIs + NVP + LPV/r
Participants will receive 2 NRTIs + NVP + LPV/r.
Drug: Nucleoside Reverse Transcriptase Inhibitors (NRTIs)

Chosen by the site investigator and dosed according to World Health Organization (WHO) or individual country or local standard guidelines.

Drug: Nevirapine (NVP)

Administered orally. Dosed according to study step/participant's age/participant's weight.

Drug: Lopinavir/Ritonavir (LPV/r)

Administered orally. Dosed according to study step and participant's age.

Experimental: Cohort 1, Regimen 2R: 2 NRTIs + NVP + RAL
Participants will receive 2 NRTIs + NVP + RAL.
Drug: Nucleoside Reverse Transcriptase Inhibitors (NRTIs)

Chosen by the site investigator and dosed according to World Health Organization (WHO) or individual country or local standard guidelines.

Drug: Nevirapine (NVP)

Administered orally. Dosed according to study step/participant's age/participant's weight.

Drug: Raltegravir (RAL)

Administered orally. Dosed according to study step and participant's age.

Experimental: Cohort 2, Regimen 2R: 2 NRTIs + NVP + RAL
Participants will receive 2 NRTIs + NVP + RAL.
Drug: Nucleoside Reverse Transcriptase Inhibitors (NRTIs)

Chosen by the site investigator and dosed according to World Health Organization (WHO) or individual country or local standard guidelines.

Drug: Nevirapine (NVP)

Administered orally. Dosed according to study step/participant's age/participant's weight.

Drug: Raltegravir (RAL)

Administered orally. Dosed according to study step and participant's age.

Experimental: Cohort 1, Regimen 2RV: 2 NRTIs + NVP + RAL + VRC01
Participants will receive 2 NRTIs + NVP + RAL + VRC01.
Drug: Nucleoside Reverse Transcriptase Inhibitors (NRTIs)

Chosen by the site investigator and dosed according to World Health Organization (WHO) or individual country or local standard guidelines.

Drug: Nevirapine (NVP)

Administered orally. Dosed according to study step/participant's age/participant's weight.

Drug: Raltegravir (RAL)

Administered orally. Dosed according to study step and participant's age.

Drug: VRC01

40 mg/kg administered subcutaneously

Detailed Description:

The purpose of this study is to 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.
The study will enroll two cohorts. Cohort 1 will include infants at high risk for in utero HIV infection. Cohort 2 will include in utero HIV-infected, ART-started infants.
Three early intensive therapy regimens will be assessed. Regimen 1L will include 2 nucleoside reverse transcriptase inhibitors (NRTIs) plus nevirapine (NVP) plus lopinavir/ritonavir (LPV/r). Regimen 2R will include 2 NRTIs plus NVP plus raltegravir (RAL). Regimen 2RV will include 2 NRTIs plus NVP plus RAL plus VRC01 monoclonal antibody.
The study will be conducted in four steps. In Step 1, Cohort 1 infants will be enrolled for evaluation of HIV infection and initiation of early intensive therapy within 48 hours of birth. Infants in whom in utero HIV infection is excluded will switch from the study regimen to standard perinatal prophylaxis per local guidelines within two weeks; these infants will continue in Step 1 safety monitoring for two additional weeks, undergo final HIV testing at approximately 12 weeks of age, and then exit the study. Infants in whom in utero HIV infection is confirmed will enter Step 2 at least two weeks after enrollment in Step 1.
In Step 2, Cohort 1 infants identified with in utero HIV infection and Cohort 2 infants will receive the study regimen for up to 192 weeks. Beginning at Step 2 Week 84, children who achieved HIV RNA suppression by Week 24, and maintained suppression thereafter, with no HIV RNA detected at or after Week 48, will be evaluated for possible treatment cessation.
In Step 3, children in Step 2 who meet criteria for treatment cessation will stop ART, and be closely monitored for viral rebound for up to five years.
In Step 4, children who experience viral rebound in Step 3 will re-start ART, and be closely monitored for viral re-suppression on ART until five years of age or six months after re-suppression, whichever is later.
HIV-uninfected infants will be followed for 12 weeks. HIV-infected infants will be followed for up to 192 weeks in Step 2 (on ART); those entering Step 3 will be followed for primary endpoint ascertainment at 48 weeks and for up to a total of five years (off ART) in this step.

Eligibility

Eligibility

Ages Eligible for Study: up to 10 Days  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Maternal Inclusion Criteria, Cohort 1 and Cohort 2

  • Mothers will be eligible to enroll with EITHER:
    • Presumed HIV infection defined as greater than or equal to one positive rapid HIV antibody test obtained in the peripartum period. Maternal infection must be confirmed, with confirmatory results available within 10 business days of enrollment (see below). OR
    • Confirmed HIV infection defined as positive results from two samples collected at different time points. All samples tested must be whole blood, serum or plasma. More information on this criterion is available in the protocol.
  • Willing and able to provide written informed consent for participation of herself and her infant (Step 1 and/or Step 2 as applicable). The mother must be of an age to provide legal informed consent as defined by the country in which she resides. If not, informed consent must be obtained from a legal guardian.

  • Maternal Inclusion Criteria, Cohort 1 Only
  • Infant eligible and enrolled in Cohort 1
  • No receipt of ARVs during the current pregnancy
    • Note: Maternal receipt of ARVs prior to the current pregnancy (including NVP) or during labor and/or the intrapartum period (within five days prior to delivery) of the current pregnancy is permissible.

    • Maternal Inclusion Criteria, Cohort 2 Only
  • Infant eligible and enrolled in Cohort 2
    • Note: Maternal receipt of ARVs during the current pregnancy and/or the intrapartum period for the current pregnancy is permissible.

    • Infant Inclusion Criteria, Step 1, Evaluation and Initial Treatment of High-Risk Infants
  • Less than or equal to 48 hours of age
  • Greater than or equal to 36 weeks gestational age at birth (assessment of gestational age will be based on the best clinical estimate determined by date of last menstrual period, antenatal ultrasound, fundal height, or Ballard Score)
  • Greater than or equal to 2 kg at birth
  • Mother with presumed or confirmed HIV infection per criteria above.
  • Mother did not receive ARVs during the current pregnancy per criteria above.
  • Able to take ARVs by mouth, nasogastric tube, or gastrostomy tube

  • Infant Inclusion Criteria, Step 2, Management of Infants with Confirmed in utero HIV Infection
  • Able to take ARVs by mouth, nasogastric tube, or gastrostomy tube.
  • Cohort 1 Only
    • Must have been enrolled in Step 1
    • Confirmed in utero HIV infection (see study protocol for more information)
  • Cohort 2 Only
    • Less than or equal to 10 days of age
    • Greater than or equal to 36 weeks gestational age at birth (assessment of gestational age will be based on the best clinical estimate determined by date of last menstrual period, antenatal ultrasound, fundal height, or Ballard Score)
    • Greater than or equal to 2 kg at birth
    • Mother with presumed or confirmed HIV infection per criteria above
    • At least one NAT positive for HIV infection on a sample drawn within 48 hours of birth
    • Received first dose of ART within 48 hours of birth on a regimen including 2 NRTIs and at least one other agent (e.g., NVP, RAL, LPV/r)
      • Dosing of each agent in the regimen should be based on current dosing guidelines (WHO or individual country or local standard guidelines)
      • NVP dosing must be at least equivalent to current country or local standard dosing guidelines for prophylaxis
      • The FDA recommends avoiding LPV/r in infants less than 14 days of age or less than 42 weeks postmenstrual age
    • ART regimen (described in criteria above) was taken daily from date of initiation until study entry
      • Other than the exception in the next bullet point for NVP, each agent in the regimen must be taken daily from the date of initiation
      • NVP should ideally be taken daily from the date of initiation and must be taken on at least two of the first five days of life (i.e., it is acceptable for NVP to not be taken on up to three of the first five days of life)

      • Infant Inclusion Criteria, Step 3, Treatment Cessation
  • Note: The criteria in this section may be modified in response to expert panel review.
  • Must have been enrolled in Step 2.
  • Must have reached Step 2 Week 96.
  • Must have the following based on testing at the local CLIA-certified (US sites) or VQA-certified (non-US sites) laboratory:
    • No confirmed plasma HIV RNA greater than or equal to 200 copies/mL at Step 2 Week 24 and up to but excluding Step 2 Week 48 (see the study protocol for procedural guidance related to this criterion) AND
    • No plasma HIV RNA detected at Step 2 Week 48 and thereafter
      • Note: Sample dilution for HIV RNA assays should not occur at or after Step 2 Week 24. In the event that an adequate sample volume cannot be collected at a given study visit, the infant should return to the clinic on a different day within the allowable visit window for a repeat specimen collection attempt. If the repeat attempt is unsuccessful, or if for any reason sample dilution is unavoidable, the infant may be considered for entry into Step 3 as long as dilution occurs only once at or after Step 2 Week 24 and the HIV RNA assays immediately preceding and immediately following the diluted assay are not performed with a diluted sample and provide results that otherwise meet criteria for entry into Step 3.
  • If breastfed, must have permanently ceased breastfeeding, with no exposure to breast milk for at least six weeks prior to specimen collection for the testing specified in criterion below.
  • Must have met ALL of the following additional criteria while in Step 2, obtained at greater than or equal to Step 2 Week 84 and less than or equal to Step 2 Week 192:
    • Two consecutive negative HIV antibody tests by fourth generation enzyme-linked immunosorbent assay (ELISA) (performed in the study's designated central laboratory) at least 8 weeks apart
    • Two consecutive HIV DNA tests with no DNA detected in at least 850,000 PBMCs assayed (performed in the study's designated central laboratory) at least 8 weeks apart
      • Note: One million PBMCs should ideally be assayed; to accommodate variable specimen volumes and cell counts, however, a minimum of 850,000 PBMCs assayed is acceptable.
    • No plasma HIV RNA detected at the time of the second consecutive negative HIV DNA test (based on testing performed in the study's designated VQA-certified central laboratory)
    • CD4 cell percentage greater than or equal to 25 AND CD4 cell absolute count greater than or equal to the lower limit of normal for age (i.e., 1000 cells/mL if 2-3 years of age, greater than or equal to 750 cells/mL if 3-4 years of age)
    • Infant assessed by the site investigator or designee as expected to comply with the Step 3 Schedule of Evaluations
    • Mother (or legal guardian if applicable) willing and able to provide written informed consent for child's participation in Step 3 and Step 4
  • No plasma HIV RNA detected by testing performed at the local CLIA-certified (US sites) or VQA-certified (non-US sites) laboratory, after criteria above have been confirmed, with specimen collection for the assay within 14 days prior to Step 3 Entry.

  • Infant Inclusion Criteria, Step 4, Treatment Re-Initiation
  • Must have been enrolled in Step 3.
  • Plasma HIV RNA greater than or equal to LOD based on by standard quantitative testing performed at the local CLIA-certified (US sites) or VQA-certified (non-US sites) laboratory after ART cessation (see the study protocol for procedural guidance related to this criterion).
    • Note: Regardless of HIV RNA test results, any child enrolled in Step 3 may re-initiate ART at the request of his or her parent or guardian; any such child is eligible for inclusion in Step 4.

    • Infant Exclusion Criteria, Step 1 and Step 2
  • 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

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, California
University of California, UC San Diego CRS- Mother-Child-Adolescent HIV Program Recruiting
La Jolla, California, United States, 92093-0672
Contact: Megan Loughran, B.A.    858-534-9218    meloughran@ucsd.edu
Usc La Nichd Crs Recruiting
Los Angeles, California, United States, 90089
Contact: Eva A. Operskalski, Ph.D.    323-865-1554    eva@usc.edu
David Geffen School of Medicine at UCLA NICHD CRS Recruiting
Los Angeles, California, United States, 90095-1752
Contact: Michele F. Carter, B.S., R.N.    310-206-6369    mfcarter@mednet.ucla.edu
United States, Colorado
Univ. of Colorado Denver NICHD CRS Recruiting
Aurora, Colorado, United States, 80045
Contact: Emily Barr, C.P.N.P., C.N.M., M.S.N.    720-777-6752    emily.barr@childrenscolorado.org
United States, Florida
South Florida CDTC Ft Lauderdale NICHD CRS Recruiting
Fort Lauderdale, Florida, United States, 33316
Contact: Hanna Major-Wilson, A.R.N.P.    954-728-1125    hmajorwilson@browardhealth.org
Univ. of Florida Jacksonville NICHD CRS Recruiting
Jacksonville, Florida, United States, 32209
Contact: Saniyyah Mahmoudi, A.R.N.P.    904-244-5331    saniyyah.mahmoudi@jax.ufl.edu
Pediatric Perinatal HIV Clinical Trials Unit CRS Recruiting
Miami, Florida, United States, 33136
Contact: Grace Alvarez    305-243-4447    galvarez2@miami.edu
United States, Georgia
Emory University School of Medicine NICHD CRS Recruiting
Atlanta, Georgia, United States, 30322
Contact: LaTeshia Thomas-Seaton    404-616-5936    lseaton@emory.edu
United States, Illinois
Rush Univ. Cook County Hosp. Chicago NICHD CRS Recruiting
Chicago, Illinois, United States, 60612
Contact: Maureen McNichols, R.N., M.S.N., C.C.R.C.    1-312-572-4541    maureen_mcnichols@rush.edu
Lurie Children's Hospital of Chicago (LCH) CRS Recruiting
Chicago, Illinois, United States, 60614-3393
Contact: Margaret Ann Sanders, M.P.H.    312-227-8275    msanders@luriechildrens.org
United States, Maryland
Johns Hopkins Univ. Baltimore NICHD CRS Recruiting
Baltimore, Maryland, United States, 21287
Contact: Aleisha Collinson-Streng, R.N., A.C.R.N.    1-443-801-7301    acolli14@jhmi.edu
United States, Massachusetts
Boston Medical Center Ped. HIV Program NICHD CRS Recruiting
Boston, Massachusetts, United States, 02118
Contact: Debra McLaud, R.N.    617-414-5813    demclaud@bmc.org
United States, New York
Bronx-Lebanon Hospital Center NICHD CRS Recruiting
Bronx, New York, United States, 10457
Contact: Martha Cavallo, A.N.P., C.R.N.P.    1-718-960-1010    mcavallo@bronxleb.org
Jacobi Med. Ctr. Bronx NICHD CRS Recruiting
Bronx, New York, United States, 10461
Contact: Marlene Burey, R.N., M.S.N., P.N.P.    1-718-918-4783    marlene.burey@nychhc.org
SUNY Stony Brook NICHD CRS Recruiting
Stony Brook, New York, United States, 11794
Contact: Erin Infanzon    631-444-8832    Erin.Infanzon@stonybrookmedicine.edu
United States, Pennsylvania
Philadelphia IMPAACT Unit CRS Withdrawn
Philadelphia, Pennsylvania, United States, 9104
United States, Tennessee
St. Jude Children's Research Hospital CRS Recruiting
Memphis, Tennessee, United States, 38105-3678
Contact: Jill Utech, M.S.N.    901-595-5059    jill.utech@stjude.org
United States, Texas
Texas Children's Hospital CRS Recruiting
Houston, Texas, United States, 77030-2399
Contact: Chivon D. McMullen-Jackson, B.S.N., A.D.N., R.N.    832-824-1339    cdmcmull@texaschildrens.org
United States, Washington
Seattle Children's Research Institute CRS Recruiting
Seattle, Washington, United States, 98101
Contact: Amanda Robson Nuss, B.S.    206-884-1535    amanda.robson@seattlechildrens.org
Univ. of Washington NICHD CRS Withdrawn
Seattle, Washington, United States, 98195
Argentina
Hosp. General de Agudos Buenos Aires Argentina NICHD CRS Withdrawn
Buenos Aires, Argentina, C1221ADC
Brazil
Hospital Nossa Senhora da Conceicao NICHD CRS Completed
Porto Alegre, Rio Greande Do Sul, Brazil, 91350-200
SOM Federal University Minas Gerais Brazil NICHD CRS Recruiting
Minas Gerais, Brazil, 30.130-100
Contact: Flavia G. Ferreira, M.D., D.Sc.    55-31-34099111    ffaleiroferreira@gmail.com
Hospital Federal dos Servidores do Estado NICHD CRS Recruiting
Rio De Janeiro, Brazil, 20221-903
Contact: Leon C. Sidi, M.D.    55-21-22330018    leon@diphse.com.br
Instituto de Puericultura e Pediatria Martagao Gesteira - UFRJ NICHD CRS Recruiting
Rio De Janeiro, Brazil, 21941-612
Contact: Maria da Conceicao C. Sapia, M.D.    55-21-31482255    macher.rlk@terra.com.br
Hosp. Geral De Nova Igaucu Brazil NICHD CRS Recruiting
Rio De Janeiro, Brazil, 26030
Contact: Gisely G. Falco    55-21-26676059    gisely.falco@gmail.com
Univ. of Sao Paulo Brazil NICHD CRS Recruiting
São Paulo, Brazil, 14049-900
Contact: Adriana A. Barbaro    55-1632345516    a.tiraboschi@uol.com.br
Haiti
Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS Recruiting
Port-au-Prince, Haiti, HT-6110
Contact: Cynthia Riviere, M.D.    509-22222241    criviere@gheskio.org
Kenya
Kenya Medical Research Institute / Walter Reed Project Clinical Research Center, Kericho CRS Recruiting
Kericho, Kenya, 20200
Contact: Samwel K. Chirchir, R.N., B.Sc.    254-522-030388    Samwel.Chirchir@usamru-k.org
Malawi
Malawi CRS Recruiting
Lilongwe, Central, Malawi
Contact: Whitney Ewing    265-993 67 50 24    wewing@email.unc.edu
Blantyre CRS Recruiting
Blantyre, Malawi
Contact: Bonus Makanani, M.B.B.S., B.Sc.    265-1875129    bmakanani@jhu.medcol.mw
Puerto Rico
University of Puerto Rico Pediatric HIV/AIDS Research Program CRS Recruiting
San Juan, Puerto Rico, 00935
Contact: Ruth Santos, B.S.N., R.N., M.P.H.    787-759-9595    ruth.santos@upr.edu
San Juan City Hosp. PR NICHD CRS Withdrawn
San Juan, Puerto Rico, 00936
South Africa
Soweto IMPAACT CRS Recruiting
Johannesburg, Gauteng, South Africa, 1862
Contact: Nasreen Abrahams, M.B.A., B.Tech    27-11-9899700    abrahamsn@phru.co.za
Wits RHI Shandukani Research Centre CRS Completed
Johannesburg, Gauteng, South Africa, 2001
Umlazi CRS Recruiting
Durban, Kwa Zulu Natal, South Africa, 4001
Contact: Vani Chetty    27-31-2601998    Chettyv1@ukzn.ac.za
Famcru Crs Recruiting
Tygerberg, Western Cape Province, South Africa, 7505
Contact: Joan Coetzee    27-21-9384157    joan@sun.ac.za
Tanzania
Kilimanjaro Christian Medical Centre (KCMC) Recruiting
Moshi, Tanzania
Contact: Cynthia A. Asiyo    255-753698484    cynthia.asiyo@duke.edu
Thailand
Siriraj Hospital ,Mahidol University NICHD CRS Recruiting
Bankok, Bangkoknoi, Thailand, 10700
Contact: Watcharee Lermankul    66-2-4197000 Ext. 5695    watchareeped@gmail.com
Chiangrai Prachanukroh Hospital NICHD CRS Recruiting
Chiang Mai, Thailand, 50100
Contact: Pra-ornsuda Sukrakanchana    66-81-7468858    Pra-ornsuda.Sukrakanchana@phpt.org
Uganda
Baylor-Uganda CRS Recruiting
Kampala, Uganda
Contact: Violet Korutaro    256-417-119200    vkorutaro@baylor-uganda.org
MU-JHU Research Collaboration (MUJHU CARE LTD) CRS Recruiting
Kampala, Uganda
Contact: Carolyne P. Onyango, MB ChB, M.S.    256-414-541044    carolonyango@mujhu.org
Zambia
George CRS Completed
Lusaka, Zambia, 10101
Zimbabwe
Seke North CRS Recruiting
Chitungwiza, Zimbabwe
Contact: Suzen Maonera, M.Sc., B.Sc., R.N.    263-772-268521    smaonera@uzchs-ctrc.org
St Mary's CRS Recruiting
Chitungwiza, Zimbabwe
Contact: Emmie Marote, R.N., B.A.    263-772-268519    emarote@uzchs-ctrc.org
Harare Family Care CRS Recruiting
Harare, Zimbabwe
Contact: Sukunena J. Maturure, RGN    263-712437682    sjmaturure@uzcrc.co.zw

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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

More Information

Additional Information:

Related Info

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)  
ClinicalTrials.gov Identifier: NCT02140255   History of Changes  
Other Study ID Numbers: IMPAACT P1115  
  UM1AI068632  
  UM1AI068616  
  UM1AI106716  
  11954  
Study First Received: May 13, 2014  
Last Updated: March 29, 2019  

Studies a U.S. FDA-regulated Drug Product: Yes  
Studies a U.S. FDA-regulated Device Product: No  

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

HIV Remission

Additional relevant MeSH terms:
HIV Infections
Ritonavir
Lopinavir
Raltegravir Potassium
Nevirapine
Reverse Transcriptase Inhibitors

ClinicalTrials.gov processed this data on May 24, 2019
This information is provided by ClinicalTrials.gov.