The Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age

• ClinicalTrials.gov Identifier: NCT03760458
• Recruitment Status: Recruiting
• First Posted: November 30, 2018
• Last Update Posted: February 5, 2021
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborators: International Maternal Pediatric Adolescent AIDS Clinical Trials Network; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institute of Mental Health (NIMH); ViiV Healthcare Ltd.
• Information provided by (Responsible Party): National Institute of Allergy and Infectious Diseases (NIAID)

Study Description

Brief Summary:

The purpose of this study is to examine the pharmacokinetics, safety, and tolerability of abacavir/dolutegravir/lamivudine dispersible and immediate release tablets in HIV-1-infected children less than 12 years of age.

Condition or disease	Intervention/treatment	Phase
HIV Infections	Drug: Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets; Drug: Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release)	Phase 1; Phase 2

Detailed Description:

This study will examine the pharmacokinetics (PK), safety, and tolerability of fixed-dose combination abacavir (ABC)/dolutegravir (DTG)/lamivudine (3TC) dispersible and immediate release tablets in HIV-1-infected children less than 12 years of age.

Children will be enrolled into one of five ABC/DTG/3TC dosing groups based on their weight. The first 5-7 children within each weight-band will undergo intensive PK assessments 5-10 days after starting ABC/DTG/3TC to confirm dose selection. Children will remain on their initial dose of ABC/DTG/3TC through Week 4. After Week 4, ABC/DTG/3TC dosing will be adjusted based on PK results at the individual or weight-band level, and/or an individual child's growth and weight gain over time.

Follow-up study visits for all participants will occur at Weeks 1, 4, 12, 24, 36, and 48. Some participants may attend additional study visits at Weeks 2, 6, 8, 16, and/or 20. Study visits may include physical examination, study drug adherence and tolerability questionnaires, blood collection, and intensive PK sampling. Following the Week 48 study visit, some children may continue on the study for up to 144 weeks.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 75 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase I/II Study of the Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age
• Actual Study Start Date: July 20, 2020
• Estimated Primary Completion Date: March 17, 2022
• Estimated Study Completion Date: June 17, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: Weight Band #1 (6 to less than 10 kg); Children weighing 6 to less than 10 kg will receive 3 dispersible tablets of ABC/DTG/3TC, beginning at study entry, for at least 48 weeks and up to 144 weeks.	Drug: Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets; Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food
Experimental: Weight Band #2 (10 to less than 14 kg); Children weighing 10 to less than 14 kg will receive 4 dispersible tablets of ABC/DTG/3TC, beginning at study entry, for at least 48 weeks and up to 144 weeks.	Drug: Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets; Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food
Experimental: Weight Band #3 (14 to less than 20 kg); Children weighing 14 to less than 20 kg will receive 5 dispersible tablets of ABC/DTG/3TC, beginning at study entry, for at least 48 weeks and up to 144 weeks.	Drug: Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets; Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food
Experimental: Weight Band #4 (20 to less than 25 kg); Children weighing 20 to less than 25 kg will receive 6 dispersible tablets of ABC/DTG/3TC, beginning at study entry, for at least 48 weeks and up to 144 weeks.	Drug: Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets; Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food
Experimental: Weight Band #5 (25 kg or greater); Children weighing 25 kg or greater will receive 1 immediate release tablet of ABC/DTG/3TC, beginning at study entry, for at least 48 weeks and up to 144 weeks.	Drug: Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release); Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food; Other Name: Triumeq

Outcome Measures

Primary Outcome Measures :

1. Geometric mean area under the plasma concentration-time curve over 24 hours at steady-state (AUC0-24h) for ABC, DTG, and 3TC [ Time Frame: Measured at Week 1 ]
   Based on analysis of intensive PK samples collected at Week 1 and compared within each weight band to the PK targets specified in the study protocol
2. Geometric mean maximum plasma concentration (Cmax) for ABC, DTG, and 3TC [ Time Frame: Measured at Week 1 ]
   Based on analysis of intensive PK samples collected at Week 1
3. Geometric mean concentration at 24 hours post-dose (C24h) for ABC, DTG, and 3TC [ Time Frame: Measured at Week 1 ]
   Based on analysis of intensive PK samples collected at Week 1 and compared within each weight band to the PK targets specified in the study protocol
4. Number of participants who had adverse events [ 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
5. Number of participants who had Grade 3 or Grade 4 adverse events assessed as related to study drug [ Time Frame: Measured through Week 24 ]
   Based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017
6. Number of participants who had Grade 5 adverse events assessed as related to study drug [ Time Frame: Measured through Week 24 ]
   Based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017
7. Number of participants who had life-threatening adverse events assessed as related to study drug [ Time Frame: Measured through Week 24 ]
   Based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017
8. Number of participants who had serious adverse events assessed as related to study drug [ Time Frame: Measured through Week 24 ]
   Based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017
9. Number of participants who had adverse events assessed as related to study drug that lead to permanent discontinuation of study drug [ Time Frame: Measured through Week 24 ]
   Based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017

Secondary Outcome Measures :

1. Area under the plasma concentration-time curve over 24 hours at steady-state (AUC0-24h) for ABC, DTG, and 3TC [ Time Frame: Measured through Week 48 ]
   Derived from population PK modeling with sampling
2. Concentration at time 0 (pre-dose) (C0h) for ABC, DTG, and 3TC [ Time Frame: Measured through Week 48 ]
   Derived from population PK modeling with sampling
3. Concentration at 24 hours post-dose (C24h) for ABC, DTG, and 3TC [ Time Frame: Measured through Week 48 ]
   Derived from population PK modeling with sampling
4. Maximum plasma concentration (Cmax) for ABC, DTG, and 3TC [ Time Frame: Measured through Week 48 ]
   Derived from population PK modeling with sampling
5. Time to maximum concentration (Tmax) for ABC, DTG, and 3TC [ Time Frame: Measured through Week 48 ]
   Derived from population PK modeling with sampling
6. Apparent oral clearance (CL/F) for ABC, DTG, and 3TC [ Time Frame: Measured through Week 48 ]
   Derived from population PK modeling with sampling
7. Half-life (t1/2) for ABC, DTG, and 3TC [ Time Frame: Measured through Week 48 ]
   Derived from population PK modeling with sampling
8. Number of participants who had adverse events [ Time Frame: Measured through Week 48 ]
   Based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017
9. Number of participants who had Grade 3 or Grade 4 adverse events assessed as related to study drug [ Time Frame: Measured through Week 48 ]
   Based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017
10. Number of participants who had Grade 5 adverse events assessed as related to study drug [ Time Frame: Measured through Week 48 ]
    Based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017
11. Number of participants who had life-threatening adverse events assessed as related to study drug [ Time Frame: Measured through Week 48 ]
    Based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017
12. Number of participants who had serious adverse events assessed as related to study drug [ Time Frame: Measured through Week 48 ]
    Based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017
13. Number of participants who had adverse events assessed as related to study drug that lead to permanent discontinuation of study drug [ Time Frame: Measured through Week 48 ]
    Based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017
14. Number of participants who had adverse events [ Time Frame: Measured through Week 144 ]
    Based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017
15. Number of participants who had Grade 3 or Grade 4 adverse events assessed as related to study drug [ Time Frame: Measured through Week 144 ]
    Based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017
16. Number of participants who had Grade 5 adverse events assessed as related to study drug [ Time Frame: Measured through Week 144 ]
    Based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017
17. Number of participants who had life-threatening adverse events assessed as related to study drug [ Time Frame: Measured through Week 144 ]
    Based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017
18. Number of participants who had serious adverse events assessed as related to study drug [ Time Frame: Measured through Week 144 ]
    Based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017
19. Number of participants who had adverse events assessed as related to study drug that lead to permanent discontinuation of study drug [ Time Frame: Measured through Week 144 ]
    Based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017
20. Proportion of participants with HIV-1 RNA levels meeting virologic response criteria [ Time Frame: Measured through Week 48 ]
    Based on laboratory evaluations
21. Proportion of participants with HIV-1 RNA levels meeting virologic response criteria [ Time Frame: Measured through Week 144 ]
    Based on laboratory evaluations
22. Number of participant with HIV-1 RNA greater than or equal to 200 copies/mL at Weeks 4, 24, and 48 (snapshot algorithm) [ Time Frame: Measured through Week 48 ]
    Based on laboratory evaluations
23. Number of participants with HIV-1 RNA greater than or equal to 50 copies/mL at Weeks 4, 24, and 48 (snapshot algorithm) [ Time Frame: Measured through Week 48 ]
    Based on laboratory evaluations
24. Median changes (with IQR) in CD4+ cell count and percentage at Weeks 4, 24, and 48 [ Time Frame: Measured through Week 48 ]
    Based on laboratory evaluations
25. Median changes (with IQR) in CD4+ cell count and percentage through Week 144 [ Time Frame: Measured through Week 144 ]
    Based on laboratory evaluations
26. Median changes (with IQR) in total cholesterol, HDL, LDL, and triglycerides at Weeks 24 and 48 [ Time Frame: Measured through Week 48 ]
    Based on laboratory evaluations
27. Aggregated data on parent/guardian reported adherence to study drug at Weeks 4, 24, and 48 [ Time Frame: Measured through Week 48 ]
    Based on questionnaire responses
28. Aggregated data on parent/guardian reported tolerability (i.e., palatability and acceptability) of study drug at Weeks 4, 12, 24, and 48 [ Time Frame: Measured through Week 48 ]
    Based on questionnaire responses
29. ARV resistance mutations at time of virologic failure (and at entry for children with resistance identified at time of virologic failure) [ Time Frame: Measured through Week 48 ]
    Based on laboratory evaluations

Eligibility Criteria

• Ages Eligible for Study: 6 Months to 12 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Less than 12 years of age at entry

  • Note: Accrual will initially be restricted to children six months (180 days) of age and older. Once the Protocol Team has confirmed that data are available to support the specified weight band dosing for children less than six months of age, this restriction will be lifted.
• Weight 6 kg to less than 40 kg at entry

• Antiretroviral therapy (ART)-naïve at entry or has been taking a stable ART regimen for at least six consecutive months at entry

  • Note: For ART-naïve children, receipt of antiretroviral (ARV) prophylaxis prior to diagnosis of HIV infection is permitted. For these children, ascertainment of this criterion may be based on parent or guardian report only, but available medical records should also be reviewed in relation to this criterion.
  • Note: For ART-experienced children (on a stable ART regimen), dose and formulation changes (e.g., for growth) within the six months prior to entry are permitted. For these children, ascertainment of this criterion must be based on medical records.

• For ART-experienced children (on a stable ART regimen), has had a suppressed HIV viral load (HIV-1 RNA less than 200 copies/mL) for at least six consecutive months prior to entry

  • Note: To fulfill this criterion, at least two documented HIV-1 RNA results less than 200 copies/mL must be available, one based on a specimen collected at least six months prior to entry and one based on a specimen collected within 30 days prior to entry.
  • Note: Any documented HIV-1 RNA result greater than or equal to 200 copies/mL based on a specimen collected within six months prior to entry is exclusionary (see exclusion criterion below).

• At screening, has normal, Grade 1, or Grade 2 laboratory test results for all of the following, based on testing of specimens collected within 30 days prior to entry and grading per the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (refer to the study protocol for guidance on severity grading):

  • Hemoglobin (greater than or equal to 8.5 g/dL or greater than or equal to 5.25 mmol/L)
  • Absolute neutrophil count (greater than or equal to 600 cells/mm^3 or greater than or equal to 0.600 x 10^9 cells/L)
  • Platelet count (greater than or equal to 50,000 cells/mm^3 or greater than or equal to 50.00 x 10^9 cells/L)
  • Estimated glomerular filtration rate (eGFR; bedside Schwartz formula; greater than or equal to 60 ml/min/1.73 m^2)
  • Alanine transaminase (ALT) (less than 5.0 x ULN)
  • Aspartate aminotransferase (AST) (less than 5.0 x ULN)
  • Total bilirubin (less than 2.6 x ULN)
  • Direct bilirubin (less than or equal to ULN)
  • Note: Laboratory tests may be repeated during the screening period (i.e., within 30 days prior to entry), with the latest results used for eligibility determination.
  • Note: For treatment-experienced children on an atazanavir-containing ART regimen, Grade 3 or higher total bilirubin is permitted.
• At screening, has a negative test result for hepatitis B surface antigen based on testing of a specimen collected within 30 days prior to entry

• Confirmed HIV-1-infection based on documented testing of two samples collected at different time points:

  • Sample #1 may be tested using any of the following:

    • Two rapid antibody tests from different manufacturers or based on different principles and epitopes
    • One enzyme immunoassay OR Western Blot OR immunofluorescence assay OR chemiluminescence assay
    • One HIV DNA polymerase chain reaction (PCR)
    • One quantitative HIV RNA PCR (above the limit of detection of the assay)
    • One qualitative HIV RNA PCR
    • One HIV total nucleic acid test

  • Sample #2 may be tested using any of the following:

    • Rapid antibody test. If this option is used in combination with two rapid tests for Sample #1, at least one of the three rapid tests must be United States Food and Drug Administration (FDA)-approved, and the third rapid test must be from a third manufacturer or based on a third principle or epitope.
    • One enzyme immunoassay OR Western Blot OR immunofluorescence assay OR chemiluminescence assay
    • One HIV DNA PCR
    • One quantitative HIV RNA PCR (above the limit of detection of the assay)
    • One qualitative HIV RNA PCR
    • One HIV total nucleic acid test
  • Whole blood, plasma, or serum samples must be tested. If both samples are tested using antibody tests, at least one of the samples must be tested in a laboratory that operates according to Good Clinical Laboratory Practice guidelines and participates in an appropriate external quality assurance program. If nucleic acid testing is used, at least one test must be performed in a Clinical Laboratory Improvement Amendments (CLIA) certified (for US sites) or Virology Quality Assurance (VQA) certified (for non-US sites) laboratory. For tests performed in other settings, adequate source documentation including the date of specimen collection, date of testing, test performed, and test result must be available. FDA approved testing methods should be used when possible.

• HLA-B*5701-negative based on documented testing at any time prior to entry

  • Note: Documented testing is required even if the potential participant has received ABC prior to study entry.
• For females of reproductive potential (defined as having experienced menarche), not pregnant based on testing performed at screening

• For females of reproductive potential who are engaging in sexual activity that could lead to pregnancy, willing to use two methods of contraception while receiving study drug, based on participant and parent or guardian report at entry

  • One of the two methods must be highly effective; highly effective methods include surgical sterilization (i.e., hysterectomy, bilateral oophorectomy, tubal ligation, or salpingectomy) and the following:

    • Contraceptive intrauterine device or intrauterine system
    • Subdermal contraceptive implant
    • Progestogen injections
    • Combined estrogen and progestogen oral contraceptive pills
    • Percutaneous contraceptive patch
    • Contraceptive vaginal ring
  • The highly effective method must be initiated prior to study entry. The second method should ideally be a barrier method. Male or female condom use is recommended with all other methods of contraception for dual protection against pregnancy and to avoid transmission of HIV and other sexually transmitted infections.
• Based on parent or guardian report at entry, child is expected to be available for 48 weeks of follow-up
• Parent or legal guardian is willing and able to provide written informed consent for child's study participation and, when applicable per local institutional review board/ethics committee (IRB/EC) policies and procedures, child is willing and able to provide written informed assent for study participation

Exclusion Criteria:

• Documented resistance to ABC, DTG, or 3TC

  • Note: Testing to rule out resistance is not required, and the M184V resistance mutation is not exclusionary.
• For ART-experienced children (on a stable ART regimen), documented HIV-1 RNA result greater than or equal to 200 copies/mL based on a specimen collected within six months prior to entry

• History of any of the following as determined by the site investigator based on participant/parent/guardian report and available medical records:

  • Malignancy (ever)
  • Hypersensitivity reaction to ABC (ever)
  • Receipt of any prohibited medication (refer to the study protocol for more information) within 30 days prior to study entry
  • Receipt of systemic interferon or any chronic systemic immunosuppressant medication within 30 days prior to study entry
  • Note: Systemic corticosteroids (e.g., prednisone or equivalent up to 2 mg/kg) taken for replacement or short course therapy are permitted. Intranasal or inhaled steroid use is also permitted.

• Has any of the following as determined by the site investigator based on participant/parent/guardian report and available medical records

  • Current clinical evidence of pancreatitis
  • Currently-active tuberculosis (TB) and/or currently receiving rifampicin-containing TB treatment
  • Currently-active AIDS-defining (WHO Clinical Stage 4) opportunistic infection
• Has any documented or suspected clinically significant medical condition or any other condition that, in the opinion of the site investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives

Contacts and Locations

Contacts

Contact: Kathryn Lypen, MPH; 919-544-7040 ext 11684; Klypen@fhi360.org

Contact: Emily Brown, MA; 919-544-7040 ext 11123; embrown@fhi360.org

Locations

United States, California

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

Pediatric Perinatal HIV Clinical Trials Unit CRS; Recruiting

Miami, Florida, United States, 33136

Contact: Grace Alvarez 305-243-4447 galvarez2@miami.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, Tennessee

St. Jude Children's Research Hospital CRS; Recruiting

Memphis, Tennessee, United States, 38105-3678

Contact: Ryan Heine 901-595-6549 Ryan.Heine@stjude.org

Botswana

Gaborone CRS; Recruiting

Gaborone, Botswana

Contact: Tebogo J. Kakhu 267-3931353 tkakhu@bhp.org.bw

Molepolole CRS; Recruiting

Gaborone, Botswana

Contact: Unoda A. Chakalisa, MBBCh 267-3910388 uchakalisa@bhp.org.bw

South Africa

Soweto IMPAACT CRS; Recruiting

Johannesburg, Gauteng, South Africa, 1862

Contact: Nastassja Ramsagar 27-11-9899858 choonilaln@phru.co.za

Wits RHI Shandukani Research Centre CRS; Recruiting

Johannesburg, Gauteng, South Africa, 2001

Contact: Hermien Gous, Pharm.D. 27-11-3585500 ext 5502 hgous@wrhi.ac.za

Famcru Crs; Recruiting

Tygerberg, Western Cape Province, South Africa, 7505

Contact: Joan Du Plessis 27-21-9384157 joan@sun.ac.za

Thailand

Siriraj Hospital, Mahidol University NICHD CRS; Recruiting

Bangkok, Bangkoknoi, Thailand, 10700

Contact: Watcharee Lermankul 66-2-4197000 ext 5695 watchareeped@gmail.com

Chiangrai Prachanukroh Hospital NICHD CRS; Recruiting

Changklan, Muang, Chiang Mai, Thailand, 50100

Contact: Pra-ornsuda Sukrakanchana 66-81-7468858 Pra-ornsuda.Sukrakanchana@phpt.org

Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS; Recruiting

Chiang Mai, Thailand, 50200

Contact: Daralak Tavornprasit, R.N., M.Sc. 66-5-3936148 ext 176 daralak@rihes.org

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

International Maternal Pediatric Adolescent AIDS Clinical Trials Network

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

National Institute of Mental Health (NIMH)

ViiV Healthcare Ltd.

Investigators

• Study Chair: Patricia Flynn, MD; St. Jude Children's Research Hospital
• Study Chair: Helena Rabie, MBChB, MMED, FCPaed; University of Stellenbosch
• Study Chair: Jennifer Kiser, PharmD, PhD; University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences

More Information

• Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
• ClinicalTrials.gov Identifier: NCT03760458
• Other Study ID Numbers: IMPAACT 2019; 38504 ( Registry Identifier: DAIDS-ES Registry Number )
• First Posted: November 30, 2018
• Last Update Posted: February 5, 2021
• Last Verified: February 2021

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.

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

Additional relevant MeSH terms:

HIV Infections; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Lamivudine; Abacavir; Dideoxynucleosides; Dolutegravir; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anti-Retroviral Agents; Antiviral Agents; Anti-Infective Agents; Anti-HIV Agents; Antimetabolites; HIV Integrase Inhibitors; Integrase Inhibitors