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More Options for Children and Adolescents (MOCHA): Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in HIV-Infected Children and Adolescents (MOCHA)

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ClinicalTrials.gov Identifier: NCT03497676
Recruitment Status : Recruiting
First Posted : April 13, 2018
Last Update Posted : July 15, 2019
Sponsor:
Collaborator:
ViiV
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary:
The purpose of this study is to determine the dosage for oral and IM Cabotegravir LA and IM Rilpiverine LA and evaluate the safety, acceptability, tolerability, and pharmacokinetics of oral and long-acting injectable cabotegravir and long-acting injectable rilpivirine in virologically suppressed HIV-infected children and adolescents.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Oral Cabotegravir (CAB) Drug: Oral Rilpivirine (RPV) Drug: Long-Acting Injectable Cabotegravir (CAB LA) Drug: Long-Acting Injectable Rilpivirine (RPV LA) Drug: Combination Antiretroviral Therapy (cART) Phase 1 Phase 2

Detailed Description:

This study will confirm the dose and evaluate the safety, acceptability, tolerability, and pharmacokinetics (PK) of oral cabotegravir (CAB), long-acting injectable cabotegravir (CAB LA), and long-acting injectable rilpivirine (RPV LA) in virologically suppressed HIV‐1 infected children and adolescents aged 12 to less than 18 years.

The study will include two cohorts of participants and two steps of study participation in each cohort. Cohort 1, Step 1 and Cohort 2, Step 3 are both a lead-in phase in which participants will receive oral formulations of the study products for at least 4 weeks, and up to 6 weeks (maximum). In Cohort 1, Step 2 and Cohort 2, Step 4, participants will receive injectable formulations of the study products. In each cohort, participants will enter the study in the oral lead-in phase (Step 1, or Step 3) and then transition to the injectable phase (Step 2, or Step 4) if eligibility criteria for the injectable phase are met. Cohort 1, Step 2, and Cohort 2, Step 4, participants, including those who prematurely permanently discontinue injectable study product, will continue on-study for an additional 48 weeks after their last study product injection, per the long-term safety and washout PK follow-up (LSFU) schedule.

The study will open to accrual in Cohort 1, in which participants, in addition to continuing their pre-study combination antiretroviral therapy (cART) regimen, will receive either oral CAB or oral RPV (Step 1) followed by either CAB LA or RPV LA (Step 2). Cohort 1 participants will be assigned either CAB (Cohort 1C) or RPV (Cohort 1R) based on their pre-study cART regimen. Participants will not stop their cART. An interim analysis of safety and PK data will be performed, and Cohort 2 will initially open to accrual based on these interim analyses; however, accrual at this stage will be limited to Cohort 1 participants who meet criteria to enter Cohort 2. After Cohort 1 is fully enrolled and a full cohort data analysis is performed, accrual into Cohort 2 will be opened to additional participants who were not previously enrolled in Cohort 1. Upon Cohort 2 Entry (i.e. Cohort 2, Step 3), all Cohort 2 participants will discontinue their pre-study cART regimen and receive both study products — CAB and RPV — at the doses confirmed in Cohort 1.

Participants in Cohort 1 will be followed for up to 64 weeks, and participants in Cohort 2 will be followed for up to 144 weeks. Enrolled parents/caregivers will complete a single qualitative phone interview.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 155 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Study of the Safety, Acceptability, Tolerability, and Pharmacokinetics of Oral and Long-Acting Injectable Cabotegravir and Long-Acting Injectable Rilpivirine in Virologically Suppressed HIV-Infected Children and Adolescents
Actual Study Start Date : March 19, 2019
Estimated Primary Completion Date : April 15, 2021
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Rilpivirine

Arm Intervention/treatment
Experimental: Cohort 1C: CAB

Step 1: CAB administered orally as one 30 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.

Step 2: CAB LA administered as one IM injection at Week 4b (Step 2 Entry) study visit (600 mg/3 mL), at Week 8 (400 mg/2 mL), and at Week 12 (400 mg/2 mL).

Drug: Oral Cabotegravir (CAB)
30 mg tablets administered orally

Drug: Long-Acting Injectable Cabotegravir (CAB LA)
Administered by intramuscular (IM) injection

Drug: Combination Antiretroviral Therapy (cART)
Participants will continue their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens will not be provided through the study.

Experimental: Cohort 1R: RPV

Step 1: RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit, for 4-6 weeks.

Step 2: RPV LA administered as one IM injection at Week 4b (Step 2 Entry) study visit (900 mg/3 mL), at Week 8 (600 mg/2 mL), and at Week 12 (600 mg/2 mL).

Drug: Oral Rilpivirine (RPV)
25 mg tablets administered orally
Other Name: Edurant

Drug: Long-Acting Injectable Rilpivirine (RPV LA)
Administered by intramuscular (IM) injection

Drug: Combination Antiretroviral Therapy (cART)
Participants will continue their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens will not be provided through the study.

Experimental: Cohort 2: CAB + RPV

Step 3: CAB administered orally as one 30 mg tablet once daily AND RPV administered orally as one 25 mg tablet once daily, beginning at the Entry visit for 4-6 weeks.

Step 4: First injection: CAB LA administered as one 600 mg (3 mL) IM injection AND RPV LA administered as one 900 mg (3 mL) IM injection, at Week 4b (Step 4 Entry). Subsequent injections: CAB LA administered as a 400 mg (2 mL) IM injection AND RPV LA administered as a 600 mg (2 mL) IM injection, every four weeks through Week 96.

Drug: Oral Cabotegravir (CAB)
30 mg tablets administered orally

Drug: Oral Rilpivirine (RPV)
25 mg tablets administered orally
Other Name: Edurant

Drug: Long-Acting Injectable Cabotegravir (CAB LA)
Administered by intramuscular (IM) injection

Drug: Long-Acting Injectable Rilpivirine (RPV LA)
Administered by intramuscular (IM) injection




Primary Outcome Measures :
  1. Number of participants who had Grade 3 or higher adverse events (Cohort 1) [ Time Frame: Measured through Week 16 ]
    Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017.

  2. Number of participants who had Grade 3 or higher adverse events assessed as related to study product/s (Cohort 1) [ Time Frame: Measured through Week 16 ]
    Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017.

  3. Number of participants who had serious adverse events meeting International Conference on Harmonisation (ICH) criteria assessed as related to study product/s (Cohort 1) [ Time Frame: Measured through Week 16 ]
    Assessed by meeting ICH criteria as related to study product/s

  4. Number of participants who permanently discontinued study product due to adverse events assessed as related to study product/s (Cohort 1) [ Time Frame: Measured through Week 16 ]
    Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017.

  5. Number of participants who died due to adverse events assessed as related to study product/s (Cohort 1) [ Time Frame: Measured through Week 16 ]
    Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017.

  6. Number of participants who had Grade 3 or higher adverse events (Cohort 2) [ Time Frame: Measured through Week 24 ]
    Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017.

  7. Number of participants who had Grade 3 or higher adverse events assessed as related to study product/s (Cohort 2) [ Time Frame: Measured through Week 24 ]
    Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017.

  8. Number of participants who had serious adverse events meeting ICH criteria assessed as related to study product/s (Cohort 2) [ Time Frame: Measured through Week 24 ]
    Assessed by meeting ICH criteria as related to study product/s

  9. Number of participants who permanently discontinued study product due to adverse events assessed as related to study product/s (Cohort 2) [ Time Frame: Measured through Week 24 ]
    Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017.

  10. Number of participants who died due to adverse events assessed as related to study product/s (Cohort 2) [ Time Frame: Measured through Week 24 ]
    Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017.


Secondary Outcome Measures :
  1. Number of participants who report tolerability of CAB LA or RPV LA (Cohort 1) [ Time Frame: Measured through Week 16 ]
    Tolerability measures will include measures of side effects, pain during and after injections, injection site reactions, and perceptions of injections from comprehensive surveys of adolescents

  2. Number of participants who report acceptability of CAB LA or RPV LA (Cohort 1) [ Time Frame: Measured through Week 16 ]
    Acceptability measures will include assessments of motivation for changing regimens, satisfaction with treatment, preferences for injectable versus oral regimen, quality of life, changes in attitudes towards the study products from comprehensive surveys of adolescents

  3. Frequency of all adverse events, regardless of severity grade (Cohort 2) [ Time Frame: Measured through Week 48 ]
    Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017.

  4. Number of participants who had Grade 3 or higher adverse events (Cohort 2) [ Time Frame: Measured through Week 48 ]
    Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017.

  5. Number of participants who had Grade 3 or higher adverse events assessed as related to study product/s (Cohort 2) [ Time Frame: Measured through Week 48 ]
    Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017.

  6. Number of participants who had serious adverse events meeting ICH criteria assessed as related to study product/s (Cohort 2) [ Time Frame: Measured through Week 48 ]
    Assessed by meeting ICH criteria as related to study product/s

  7. Number of participants who permanently discontinued study product due to adverse events assessed as related to study product/s (Cohort 2) [ Time Frame: Measured through Week 48 ]
    Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017.

  8. Number of participants who died due to adverse events assessed as related to study product/s (Cohort 2) [ Time Frame: Measured through Week 48 ]
    Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017.

  9. Plasma HIV-1 RNA levels (Cohort 2) [ Time Frame: Measured through Week 48 ]
    Based on laboratory evaluations

  10. Number of participants who are virologic failures (Cohort 2) [ Time Frame: Measured through Week 48 ]
    Based on laboratory evaluations



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Cohort 1 Step 1 and Cohort 2 Step 3

All the following criteria must be met for inclusion of any adolescent participant in Step 1 of Cohort 1, or in Step 3 of Cohort 2, unless otherwise noted:

  • At enrollment, 12 to less than 18 years of age

    • Note: For Cohort 1 Step 2 participants, age will not be exclusionary for enrollment into Cohort 2 Step 3, if otherwise eligible.
  • If not of legal age or otherwise not able to provide independent informed consent as determined by site Standard Operating Procedures (SOPs) and consistent with site Institutional Review Board (IRB)/Ethics Committee (EC) policies and procedures: Parent or legal guardian is willing and able to provide written informed consent for study participation and potential participant is willing and able to provide written assent for study participation

    • If of legal age or otherwise able to provide independent informed consent as determined by site SOPs and consistent with site IRB/EC policies and procedures: Willing and able to provide written informed consent for study participation
  • At enrollment, body weight greater than or equal to 35 kg (77 lbs)

    • Note: For Cohort 1 Step 2 participants, body weight will not be exclusionary for enrollment into Cohort 2 Step 3, if otherwise eligible.
  • For Cohort 1, at enrollment, body mass index (BMI) less than or equal to 31.5 kg/m^2
  • At enrollment, willing and able to comply with the study visit schedule and other study requirements, as determined by the site investigator or designee
  • Confirmed HIV-1-infection based on documented testing of two samples collected at different time points. More information on this criterion can be found in the protocol.
  • For at least 6 consecutive months (defined as 180 consecutive days) prior to screening, and prior to enrollment, has been on stable cART consisting of 2 or more drugs from 2 or more classes of antiretroviral drugs, as determined by the site investigator of record (IoR) or designee, and based on participant or parent/guardian report and/or available medical records.

    • Note: Participants undergoing dose modifications to their antiretroviral regimen for growth or who are switching medication formulation(s) are considered to be on a stable cART.
  • Has at least one documented plasma HIV-1 RNA less than 50 copies/mL from a specimen collected 6 to 12 months (defined as 180 to 365 days) prior to screening.
  • Has at least one documented plasma HIV-1 RNA less than 50 copies/mL from a specimen collected within 6 months (defined as within 179 days) prior to screening.
  • At screening, has Grade 2 or lower of all the following laboratory test results:

    • Alanine transaminase (ALT) (u/l)
    • Lipase (u/l)
    • Estimated creatinine clearance (CrCl; Schwartz formula mL/min/1.73m^2)
    • Platelets (cells/mm^3)
    • Hemoglobin (g/dL)
    • See study protocol for guidance on severity grading. Laboratory tests may be repeated during the study screening period, with the latest result used for eligibility determination.
  • For participants enrolling into Cohort 1, Step 1 and on an atazanavir-containing (ATV) cART regimen, at screening, has total bilirubin less than or equal to 1.5 mg/dL or normal direct bilirubin
  • At screening, has documented plasma HIV-1 RNA less than 50 copies/mL
  • At screening, corrected Q-T interval (QTc) interval (automated machine readout or calculated using either Bazett or Fredericia) less than or equal to 500 msec
  • For females, has a negative human chorionic gonadotropin (hCG) laboratory test result at entry
  • For females of childbearing potential, at entry, currently using at least one allowable effective method of contraception, and agrees to use at least one allowable effective method of contraception throughout study participation, for at least 30 days after discontinuation of oral study product, and for at least 48 weeks after discontinuation of CAB LA and/or RPV LA, and intending to delay any planned pregnancies until 30 days after last oral study product use or until 48 weeks after last injectable study product use.

    • Note: See study protocol for details regarding contraceptive counseling, a list of the allowed effective contraceptive methods for this study, and the definition of a female of childbearing potential. Hormonal-based contraceptives must have been initiated within the prescribed time, per the respective contraceptive method, to be considered effective at the time of Entry. The site IoR or designee is responsible for ensuring that the contraceptive is used in accordance with the approved product label, and counseling participants on proper use of chosen methods of contraception, including barrier methods.
  • For Cohort 1 participants enrolling to Cohort 2, have completed all scheduled study visits in Cohort 1 Step 2

Exclusion Criteria: Cohort 1 Step 1, or Cohort 2 Step 3

Adolescents will be excluded from the study if any of the following are identified during the screening period:

  • Within 6 months (defined as within 179 days) prior to screening, two consecutive documented HIV-1 RNA values greater than or equal to 50 copies/mL

    • Note: Unconfirmed virologic HIV-1 RNA value of greater than or equal to 50 copies/mL (transient detectable viremia, or "blip") prior to screening is not exclusionary.
  • For Cohort 1 participants enrolling to Cohort 2, Step 3, occurrence of any Grade 3 or higher adverse event assessed as related to study product during participation in Cohort 1 (including any long-term safety and washout PK follow-up visits).
  • For participants enrolling to Cohort 1 Step 1, based on available medical records, currently on either a cART regimen containing both a protease inhibitor (PI) and an integrase strand transfer inhibitor (INSTI), or a cART regimen containing both an INSTI and a non-nucleoside reverse transcriptase inhibitor (NNRTI).
  • As determined by the IoR or designee, and based on available medical records, known or suspected resistance to RPV
  • As determined by the IoR or designee based on available medical records, known or suspected resistance to INSTIs
  • History of congestive heart failure, symptomatic arrhythmia, or any clinically significant cardiac disease, as determined by the IoR or designee based on available medical records
  • At entry, known active tuberculosis infection, requiring anti-tuberculosis treatment, as determined by the IoR or designee based on available medical records
  • Known hepatitis B or hepatitis C infection, as determined by the IoR or designee based on available medical records
  • Clinically significant hepatic disease, as determined by the IoR or designee based on available medical records
  • Current or anticipated need for chronic anti-coagulation, as determined by the IoR or designee, based on available medical records
  • History of sensitivity to heparin or heparin-induced thrombocytopenia, as determined by the IoR or designee, based on available medical records
  • History of known or suspected bleeding disorder including history of prolonged bleeding, as determined by the IoR or designee, based on available medical records
  • Known or suspected allergy to study product components
  • More than one seizure within one year (defined as within 365 days) prior to entry, or unstable or poorly controlled seizure disorder, as determined by the IoR or designee, based on available medical records.
  • At entry, participant is receiving (or has received in the last 7 days) any disallowed medication listed in the study protocol.
  • Current inflammatory skin condition that compromises the safety of intramuscular injections as determined by the IoR or designee.
  • Has a tattoo or other dermatological condition overlying the buttock region which, in the opinion of the IoR or designee, may interfere with interpretation of injection site reactions
  • Surgically‐placed, or planned, buttock implants, per self‐report
  • For females, lactating (per self-report and/or parent/guardian report) at entry
  • Enrolled in another clinical trial of an investigational agent, device, or vaccine
  • Any other condition or social circumstance situation that, in the opinion of the IoR or designee, would make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives

Inclusion/Exclusion Criteria, Step 2 (Cohort 1 Progression Criteria, Step 1 to Step 2)

Cohort 1 Step 1 participants will be assessed for eligibility to progress from the oral lead-in phase (Step 1) to the injection phase (Step 2) primarily based on the safety assessments from the Cohort 1 Step 1 Week 4a study visit. Clinical assessments conducted prior to administering the first injection at the Week 4b visit will also be used to confirm eligibility to receive the injectable study product. See the study protocol for Week 4a and Week 4b visit scheduling, order of procedures, and visit windows, respectively.

All of the following criteria must be met in order for participants to be included in Cohort 1 Step 2:

  • Currently enrolled in Cohort 1, Step 1
  • At Cohort 1 Step 1 Week 4a study visit, or from confirmatory repeat testing of Cohort 1 Step 1 Week 4a study visit laboratory tests, has Grade 2 or lower of all the following laboratory test results:

    • ALT (u/l)
    • Lipase (u/l)
    • Estimated creatinine clearance (CrCl; Schwartz formula mL/min/1.73m^2)
    • Platelets (cells/mm^3)
    • Hemoglobin (g/dL)
    • Note: For a Grade 2 ALT test result from this visit, refer to the study protocol for required participant management. Abnormal laboratory test result values from the Week 4a visit may be repeated within the target visit window, and if confirmatory testing results in Grade 2 or lower, the participant may be eligible to continue onto the injection phase, should all other eligibility criteria be met.
  • For females, at Cohort 1 Step 1 Week 4b study visit, has a negative hCG laboratory test result
  • Assessed by the IoR or designee as sufficiently adherent in Step 1 to permit an adequate evaluation of safety and tolerability as part of the oral lead-in phase prior to entry into the injection phase
  • Participants who meet any of the following criteria will be excluded from Cohort 1 Step 2:

    • Has permanently discontinued oral study product
    • Occurrence of any grade 3 or higher adverse event assessed as related to study product during participation in Step 1
    • Any other condition or social circumstance that, in the opinion of the IoR or designee, would make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

Inclusion/Exclusion Criteria, Step 4 (Cohort 2 Progression Criteria, Step 3 to Step 4)

Cohort 2 Step 3 participants will be assessed for eligibility to progress from the oral lead-in phase (Step 3) to the injection phase (Step 4) primarily based on the safety assessments from the Cohort 2 Step 3 Week 4a study visit. Clinical assessments conducted prior to administering the first injection at the Week 4b visit will also be used to confirm eligibility to receive the injectable study product. See the study protocol for Week 4a and Week 4b visit scheduling, order of procedures, and target visit windows, respectively.

All of the following criteria must be met in order for participants to be included in Cohort 2 Step 4:

  • Currently enrolled in Cohort 2, Step 3
  • At Cohort 2 Step 3 Week 4a study visit, or from confirmatory repeat testing of Cohort 2 Step 3 Week 4a study visit laboratory tests, has Grade 2 or lower of the following laboratory test results:

    • ALT (u/l)
    • Lipase (u/l)
    • Estimated creatinine clearance (CrCl; Schwartz formula mL/min/1.73m^2)
    • Platelets (cells/mm^3)
    • Hemoglobin (g/dL)
    • Note: For a Grade 2 ALT test result from this visit, refer to the study protocol for required participant management. Abnormal laboratory test result values from the Week 4a visit may be repeated, within the target visit window, and if confirmatory testing results in Grade 2 or lower, the participant may be eligible to continue onto the injection phase, should all other eligibility criteria be met.
  • For females, at Cohort 2 Step 3 Week 4b study visit, has a negative hCG laboratory test result
  • Assessed by the IoR or designee as sufficiently adherent in Step 3 to permit an adequate evaluation of safety and tolerability as part of the oral lead-in phase prior to entry into the injection phase
  • Participants who meet any of the following criteria will be excluded from Cohort 2 Step 4:

    • Has permanently discontinued oral study products
    • Occurrence of any grade 3 or higher adverse event assessed as related to study product during participation in Cohort 2, Step 3
    • Any other condition or social circumstance that, in the opinion of the IoR or designee, would make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

Inclusion/Exclusion Criteria: Parents/Caregivers

Selected parents or caregivers of adolescents may be enrolled to complete qualitative phone interviews. See the study protocol for more information regarding the selection process, and coordination of scheduling the interviews. All of the following criteria must be met for the parent/caregiver to be enrolled:

  • Selected by the protocol team for participation in the study
  • Willing and able to provide informed (verbal or written) consent for study participation
  • Per the adolescent participant, has knowledge of how the adolescent participant tolerated the study product, and lives with or has regular supportive contact with the adolescent participant
  • Per parent/caregiver self-report, has knowledge of how the participant tolerated the study product, and lives with or has regular supportive contact with the adolescent participant
  • Willing and able to complete interview in English by phone
  • Parents and/or caregivers of participants who meet the following criterion will be excluded from study participation:

    • Any condition or social circumstance that, in the opinion of the IoR or designee, would make study participation unsafe for either the parent/caregiver or the adolescent participant, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03497676


Locations
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United States, California
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.    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.    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.    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.    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, 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   
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 Recruiting
San Juan, Puerto Rico, 00936
Contact: Lizbeth Fabregas-Troche, B.S., M.S.    787-764-3083    lfabregas@sanjuanciudadpatria.com   
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
ViiV
Investigators
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Study Chair: Carolyn Bolton Moore, MSc, MBBCh Centre for Infectious Disease Research in Zambia/University of Alabama Birmingham
Study Chair: Aditya H. Gaur, MD St. Jude Children's Research Hospital

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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT03497676     History of Changes
Other Study ID Numbers: IMPAACT 2017
30070 ( Registry Identifier: DAIDS-ES Registry Number )
First Posted: April 13, 2018    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie results in the publication, after deidentification.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Beginning 3 months following publication and available throughout period of funding of the International Maternal Pediatric Adolescent AIDS Clinical Trial (IMPAACT) Network by NIH.
Access Criteria:
  • With whom?

    • Researchers who provide a methodologically sound proposal for use of the data that is approved by the IMPAACT Network.
  • For what types of analyses?

    • To achieve aims in the proposal approved by the IMPAACT Network.
  • By what mechanism will data be made available?

    • Researchers may submit a request for access to data using the IMPAACT "Data Request" form at: https://www.impaactnetwork.org/resources/study-proposals.htm. Researchers of approved proposals will need to sign an IMPAACT Data Use Agreement before receiving the data.

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

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