Doravirine (DOR) in Human Immunodeficiency Virus (HIV)-Infected Children Aged 4 Weeks to <12 Years and <45 kg (MK-1439-066)

A Phase 2 Clinical Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Doravirine and Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate in Participants With HIV-1, Who Are 4 Weeks to Less Than 12 Years of Age and Weigh Less Than 45 kg

This is a single-group, open-label, multi-site study in pediatric participants with human immunodeficiency virus type 1 (HIV-1) infection, aged 4 weeks to <12 years and weighing <45 kg, who are treatment-naive (TN) or have been virologically suppressed (VS) on stable combination antiretroviral therapy (cART) for ≥3 months with no history of treatment failure. The primary objectives are:

• To evaluate the steady state pharmacokinetics (PK) of doravirine (DOR) [MK-1439] when given in combination with 2 nucleoside/nucleotide analog reverse transcriptase inhibitors (NRTIs) or as part of the fixed-dose combination (FDC) of DOR/lamivudine (3TC)/tenofovir disproxil fumarate (TDF) in participants ≥6 to <12 years and weighing ≥14 to <45 kg.
• To evaluate the safety and tolerability of DOR when given with 2 NRTIs or as part of the FDC of DOR/3TC/TDF, in participants ≥6 to 12 years and weighing ≥14 to <45 kg, through Week 24.

Study Overview

• Status: Recruiting
• Conditions: Human Immunodeficiency Virus (HIV) Infection
• Intervention / Treatment: Drug: Doravirine; Drug: 2 NRTIs; Drug: DOR/3TC/TDF

Detailed Description

Participants who complete the Week 96 visit will be eligible to enroll in an Extension Study and receive DOR until it is commercially available, or for up to an additional 224 weeks (whichever comes first).

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Toll Free Number; Phone Number: 1-888-577-8839; Email: Trialsites@msd.com

Study Locations

• Colombia
  • Antioquia
    • Rionegro, Antioquia, Colombia, 054040
      • Recruiting
      • Clinica Somer ( Site 1003)
      • Contact: Study Coordinator; Phone Number: +573235903405
  • Atlántico
    • Barranquilla, Atlántico, Colombia, 080020
      • Recruiting
      • Ciensalud Ips S A S ( Site 1001)
      • Contact: Study Coordinator; Phone Number: 573183894721
  • Valle del Cauca Department
    • Cali, Valle del Cauca Department, Colombia, 760042
      • Recruiting
      • CEIP - Centro de Estudios en Infectología Pediátrica ( Site 1002)
      • Contact: Study Coordinator; Phone Number: 573155798444
• Mexico
  • Mexico City
    • Coyoacán, Mexico City, Mexico, 04530
      • Completed
      • Instituto Nacional de Pediatria ( Site 0701)
    • Mexico City, Mexico City, Mexico, 06720
      • Active, not recruiting
      • Hospital Infantil de Mexico Federico Gomez ( Site 0702)
  • Yucatán
    • Mérida, Yucatán, Mexico, 97000
      • Completed
      • Unidad de Atencion Medica e Investigacion en Salud S.C. ( Site 0700)
• Russia
  • Kemerovo Oblast
    • Kemerovo, Kemerovo Oblast, Russia, 650056
      • Recruiting
      • Kuzbasskiy Center for the Prevention and Control of AIDS ( Site 0506)
      • Contact: Study Coordinator; Phone Number: 79069261368
  • Krasnodarskiy Kray
    • Krasnodar, Krasnodarskiy Kray, Russia, 350015
      • Completed
      • Clinical Centre for Prevention and Control of AIDS ( Site 0504)
  • Krasnoyarsk Krai
    • Krasnoyarsk, Krasnoyarsk Krai, Russia, 660049
      • Completed
      • Krasnoyarsk Regional Center for Prevention and Control of AIDS ( Site 0507)
  • Moscow
    • Moscow, Moscow, Russia, 105275
      • Completed
      • Infectious Clinical Hospital #2 ( Site 0501)
  • Sankt-Peterburg
    • Saint Petersburg, Sankt-Peterburg, Russia, 196645
      • Recruiting
      • FGU Republican Clinical Infectious Hospital of Roszdrav ( Site 0500)
      • Contact: Study Coordinator; Phone Number: +78124649329
• South Africa
  • Free State
    • Bloemfontein, Free State, South Africa, 9301
      • Completed
      • FARMOVS PTY LTD ( Site 0601)
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 1864
      • Recruiting
      • Perinatal HIV Research Unit ( Site 0602)
      • Contact: Study Coordinator; Phone Number: +2711 989 9700
    • Johannesburg, Gauteng, South Africa, 2001
      • Recruiting
      • Wits Reproductive Health and HIV Institute (WRHI) ( Site 0603)
      • Contact: Study Coordinator; Phone Number: +27 11 358 5300
    • Johannesburg, Gauteng, South Africa, 2093
      • Completed
      • Empilweni Services and Research Unit ( Site 0604)
  • KwaZulu-Natal
    • Durban, KwaZulu-Natal, South Africa, 4001
      • Recruiting
      • King Edward Hospital ( Site 0600)
      • Contact: Study Coordinator; Phone Number: +27312611093
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7505
      • Recruiting
      • Family Clinic Research With UBUNTU ( Site 0605)
      • Contact: Study Coordinator; Phone Number: +27219384153
    • Paarl, Western Cape, South Africa, 7626
      • Recruiting
      • Be Part Yoluntu Centre ( Site 0606)
      • Contact: Study Coordinator; Phone Number: +2782 660 5795
    • Plettenberg Bay, Western Cape, South Africa, 6600
      • Completed
      • Tsitsikamma Clinical Research Initiative (TCRI) ( Site 0607)
• Thailand
  • Chiang Mai, Thailand, 50200
    • Recruiting
    • Research Institute for Health Sciences ( Site 0902)
    • Contact: Study Coordinator; Phone Number: +6653936148
  • Khon Kaen, Thailand, 40002
    • Recruiting
    • Faculty of Medicine - Khon Kaen University ( Site 0903)
    • Contact: Study Coordinator; Phone Number: +66897112236
  • Bangkok
    • Bangkok, Bangkok, Thailand, 10700
      • Recruiting
      • Siriraj Hospital ( Site 0901)
      • Contact: Study Coordinator; Phone Number: +6624180545
• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Completed
      • University of Colorado at Denver ( Site 0108)
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Emory Children's Center ( Site 0103)
      • Contact: Study Coordinator; Phone Number: 404-727-5642

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 weeks to 11 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Has human immunodeficiency virus type 1 (HIV-1) infection confirmed at screening
• Has appropriate treatment history defined as treatment-naïve (TN) or with documented virologic suppression (HIV-1 ribonucleic acid [RNA] <50 copies/mL) on stable combination antiretroviral therapy (cART) for ≥3 months
• Body weight is >3 kg to <45 kg
• If female, is not pregnant or breastfeeding, and one of the following applies:
• Is not a woman of childbearing potential (WOCBP)
• Is a WOCBP using an acceptable form of contraception, or is abstinent
• If a WOCBP must have a negative pregnancy test (urine or serum) within 24 hours of the first dose of study intervention

Study Extension Inclusion Criteria:

• Has completed the Week 96 visit
• Is considered, in the opinion of the investigator, to have derived benefit from treatment with doravirine (DOR) plus the 2 nucleoside/nucleotide analog reverse transcriptase inhibitor (NRTIs) selected by the investigator, or doravirine/lamivudine/tenofovir disoproxil fumarate (DOR/3TC/TDF), by Week 96 of the study
• Is considered, in the opinion of the investigator, to be a clinically appropriate candidate for additional treatment with DOR regimens (DOR plus 2 NRTIs selected by the investigator or DOR/3TC/TDF)
• Understands the procedures in the study extension and has provided (or have the participant's legally acceptable representative, if applicable, provide) documented informed consent/assent to enter the study extension and continue treatment with DOR regimens (DOR plus 2 NRTIs selected by the investigator or DOR/3TC/TDF) until it is available locally in countries participating in the study or for up to an additional 224 weeks (whichever comes first)

Exclusion Criteria:

• Has evidence of renal disease
• Demonstrates evidence of liver disease
• Has clinical or laboratory evidence of pancreatitis
• Has any history of malignancy
• Has presence of any active acquired immunodeficiency syndrome (AIDS)-defining opportunistic Infection
• Has an active diagnosis of hepatitis, including hepatitis B co-infection
• Has current active tuberculosis and/or is being treated with a rifampicin-containing regimen
• Has a medical condition that precludes absorption or intake of oral pellets/granules
• Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound results of the study or interfere with participating for the entire duration of the study
• Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or other prohibited therapy
• Is currently participating in or has participated in an interventional clinical study with an investigational compound or device from 45 days prior to Day 1 through the treatment period
• Has a documented or known virologic resistance to DOR
• Has any history of viremia (HIV RNA >1000 copies/mL) after at least 3 months on a non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimen

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Doravirine as a single entity plus 2 NRTIs or Doravirine as a FDC with 3TC and TDF; Participants receive doravirine (DOR) at 7.2 mg to 100 mg, based on weight, PLUS 2 nucleoside/nucleotide analog reverse transcriptase inhibitors (NRTIs), based on local label, for 96 weeks, OR a fixed-dose combination (FDC) of doravirine/lamivudine/tenofovir disoproxil fumarate (DOR/3TC/TDF), based on weight, for 96 weeks.

Drug: Doravirine; Administered orally; Other Names: MK-1439; Drug: 2 NRTIs; Administered orally; Drug: DOR/3TC/TDF; Administered orally; Other Names: MK-1439A

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Concentration-Time Curve (AUC) From 0 to 24 Hours Postdose (AUC0-24hr) of Doravirine (DOR) Following Once-Daily Dosing in Plasma at Steady-State	Per protocol, intensive pharmacokinetic (PK) sampling includes multiple blood samples collected up to 24 hours postdose at a single visit to determine AUC0-24hr.	Intensive pharmacokinetic sampling: at designated timepoints up to 24 hours postdose
Maximum Concentration (Cmax) of DOR Following Once-Daily Dosing in Plasma at Steady-State	Per protocol, intensive PK sampling includes multiple blood samples collected up to 24 hours postdose at a single visit to determine Cmax.	Intensive pharmacokinetic sampling: at designated timepoints up to 24 hours postdose
Concentration at 24 Hours (C24) of DOR Following Once-Daily Dosing in Plasma at Steady-State	Per protocol, intensive PK sampling includes multiple blood samples collected up to 24 hours postdose at a single visit to determine C24.	Intensive pharmacokinetic sampling: at designated timepoints up to 24 hours postdose
Time to Maximum Concentration (Tmax) of DOR Following Once-Daily Dosing in Plasma at Steady-State	Per protocol, intensive PK sampling includes multiple blood samples collected up to 24 hours postdose at a single visit to determine Tmax.	Intensive pharmacokinetic sampling: at designated timepoints up to 24 hours postdose
AUC From 0 to 12 Hours Postdose (AUC0-12hr) of DOR Following Twice-Daily Dosing in Plasma at Steady-State	Per protocol, intensive PK sampling includes multiple blood samples collected up to 12 hours postdose at a single visit to determine AUC0-12hr.	Intensive pharmacokinetic sampling: at designated timepoints up to 12 hours postdose
Cmax of DOR Following Twice-Daily Dosing in Plasma at Steady-State	Per protocol, intensive PK sampling includes multiple blood samples collected up to 12 hours postdose at a single visit to determine Cmax.	Intensive pharmacokinetic sampling: at designated timepoints up to 12 hours postdose
Concentration at 12 Hours (C12) of DOR Following Twice-Daily Dosing in Plasma at Steady-State	Per protocol, intensive PK sampling includes multiple blood samples collected up to 12 hours postdose at a single visit to determine C12.	Intensive pharmacokinetic sampling: at designated timepoints up to 12 hours postdose
Tmax of DOR Following Twice-Daily Dosing in Plasma at Steady-State	Per protocol, intensive PK sampling includes multiple blood samples collected up to 12 hours postdose at a single visit to determine Tmax.	Intensive pharmacokinetic sampling: at designated timepoints up to 12 hours postdose
Percentage of Participants With ≥1 Adverse Event (AE)	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study interventions.	Up to 24 weeks
Percentage of Participants With a Grade 3 or 4 AE	Grade 3 or 4 AEs are "severe symptoms that cause inability to perform usual social and functional activities with intervention or hospitalization indicated" (Grade 3), or "potentially life-threatening events" (Grade 4).	Up to 24 weeks
Percentage of Participants With Events of Death	The percentage of participants with events of death at Week 24 will be reported.	Up to 24 weeks
Percentage of Participants Discontinuing From Study Intervention Due to an AE	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study interventions.	Up to 24 weeks
Percentage of Participants Discontinuing From Study Intervention Due to a Drug-Related AE	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, that is considered to be related to the study interventions.	Up to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma Concentration of DOR	Per protocol, sparse PK sampling includes up to 2 blood samples collected at multiple visits up to 24 weeks.	Sparse pharmacokinetic sampling: at designated timepoints up to 24 weeks
Plasma Concentration of Lamivudine (3TC) Following Once-Daily Dosing of Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF) as an Age-Appropriate Fixed-Dose Combination (FDC)	Per protocol, sparse PK sampling includes up to 2 blood samples collected at multiple visits up to 24 weeks.	Sparse pharmacokinetic sampling: at designated timepoints up to 24 weeks
Plasma Concentration of Tenofovir (TFV) Following Once-Daily Dosing of DOR/3TC/TDF as an Age-Appropriate FDC	Per protocol, sparse PK sampling includes up to 2 blood samples collected at multiple visits up to 24 weeks.	Sparse pharmacokinetic sampling: at designated timepoints up to 24 weeks
AUC0-24hr of 3TC Following Once-Daily Dosing of DOR/3TC/TDF as an Age-Appropriate FDC	Per protocol, intensive PK sampling includes multiple blood samples collected up to 24 hours postdose at a single visit to determine AUC0-24hr of 3TC.	Intensive pharmacokinetic sampling: at designated timepoints up to 24 hours postdose
AUC0-24hr of TFV Following Once-Daily Dosing of DOR/3TC/TDF as an Age-Appropriate FDC	Per protocol, intensive PK sampling includes multiple blood samples collected up to 24 hours postdose at a single visit to determine AUC0-24hr of TFV.	Intensive pharmacokinetic sampling: at designated timepoints up to 24 hours postdose
Cmax of 3TC Following Once-Daily Dosing of DOR/3TC/TDF as an Age-Appropriate FDC	Per protocol, intensive PK sampling includes multiple blood samples collected up to 24 hours postdose at a single visit to determine Cmax of 3TC.	Intensive pharmacokinetic sampling: at designated timepoints up to 24 hours postdose
Cmax of TFV Following Once-Daily Dosing of DOR/3TC/TDF as an Age-Appropriate FDC	Per protocol, intensive PK sampling includes multiple blood samples collected up to 24 hours postdose at a single visit to determine Cmax of TFV.	Intensive pharmacokinetic sampling: at designated timepoints up to 24 hours postdose
Percentage of Participants With ≥1 AE at Week 48	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study interventions.	Up to 48 weeks
Percentage of Participants With ≥1 AE at Week 96	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study interventions.	Up to 96 weeks
Percentage of Participants With Grade 3 or 4 AE at Week 48	Grade 3 or 4 AEs are "severe symptoms that cause inability to perform usual social and functional activities with intervention or hospitalization indicated" (Grade 3), or "potentially life-threatening events" (Grade 4).	Up to 48 weeks
Percentage of Participants With Grade 3 or 4 AE at Week 96	Grade 3 or 4 AEs are "severe symptoms that cause inability to perform usual social and functional activities with intervention or hospitalization indicated" (Grade 3), or "potentially life-threatening events" (Grade 4).	Up to 96 weeks
Percentage of Participants With Events of Death at Week 48	The percentage of participants with events of death at Week 48 will be reported.	Up to 48 weeks
Percentage of Participants With Events of Death at Week 96	The percentage of participants with events of death at Week 96 will be reported.	Up to 96 weeks
Percentage of Participants Discontinuing From Study Intervention Due to AE at Week 48	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study interventions.	Up to 48 weeks
Percentage of Participants Discontinuing from Study Intervention Due to AE at Week 96	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study interventions.	Up to 96 weeks
Percentage of Participants Discontinuing From Study Intervention Due to Drug-Related AE at Week 48	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, that is considered to be related to the study interventions.	Up to 48 weeks
Percentage of Participants Discontinuing From Study Intervention Due to Drug-Related AE at Week 96	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, that is considered to be related to the study interventions.	Up to 96 weeks
Percentage of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/mL at Week 24	Plasma HIV-1 RNA quantification will be performed at the central laboratory using a real-time polymerase chain reaction (PCR) assay with a lower limit of detection of 40 copies/mL.	Up to 24 weeks
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48	Plasma HIV-1 RNA quantification will be performed at the central laboratory using a real-time PCR assay with a lower limit of detection of 40 copies/mL.	Up to 48 weeks
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96	Plasma HIV-1 RNA quantification will be performed at the central laboratory using a real-time PCR assay with a lower limit of detection of 40 copies/mL.	Up to 96 weeks
Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 24	Plasma HIV-1 RNA quantification will be performed at the central laboratory using a real-time PCR assay with a lower limit of detection of 40 copies/mL.	Up to 24 weeks
Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 48	Plasma HIV-1 RNA quantification will be performed at the central laboratory using a real-time PCR assay with a lower limit of detection of 40 copies/mL.	Up to 48 weeks
Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 96	Plasma HIV-1 RNA quantification will be performed at the central laboratory using a real-time PCR assay with a lower limit of detection of 40 copies/mL.	Up to 96 weeks
Percentage of Participants With HIV-1 RNA ≥50 copies/mL at Week 24	Plasma HIV-1 RNA quantification will be performed at the central laboratory using a real-time PCR assay with a lower limit of detection of 40 copies/mL.	Up to 24 weeks
Percentage of Participants With HIV-1 RNA ≥50 Copies/mL at Week 48	Plasma HIV-1 RNA quantification will be performed at the central laboratory using a real-time PCR assay with a lower limit of detection of 40 copies/mL.	Up to 48 weeks
Percentage of Participants With HIV-1 RNA ≥50 Copies/mL at Week 96	Plasma HIV-1 RNA quantification will be performed at the central laboratory using a real-time PCR assay with a lower limit of detection of 40 copies/mL.	Up to 96 weeks
Percentage of Participants With Log10 Drop in Plasma HIV-1 RNA From Baseline at Week 24	Plasma HIV-1 RNA quantification will be performed at the central laboratory using a real-time PCR assay with a lower limit of detection of 40 copies/mL.	Baseline (Day 1) and Week 24
Percentage of Participants With Log10 Drop in Plasma HIV-1 RNA From Baseline at Week 48	Plasma HIV-1 RNA quantification will be performed at the central laboratory using a real-time PCR assay with a lower limit of detection of 40 copies/mL.	Baseline (Day 1) and Week 48
Percentage of Participants With Log10 Drop in Plasma HIV-1 RNA From Baseline at Week 96	Plasma HIV-1 RNA quantification will be performed at the central laboratory using a real-time PCR assay with a lower limit of detection of 40 copies/mL.	Baseline (Day 1) and Week 96
Change From Baseline in Cluster of Differentiation 4+ (CD4+) T-Cell Counts at Week 24	CD4+ T-cell counts will be performed at the central laboratory.	Baseline (Day 1) and Week 24
Change From Baseline in CD4+ T-Cell Counts at Week 48	CD4+ T-cell counts will be performed at the central laboratory.	Baseline (Day 1) and Week 48
Change From Baseline in CD4+ T-Cell Counts at Week 96	CD4+ T-cell counts will be performed at the central laboratory.	Baseline (Day 1) and Week 96
Viral Resistance-Associated Substitutions (RASs) to DOR or Other Treatment Components	The presence of viral RASs to DOR or other treatment components will be monitored for up to 96 weeks.	Up to 96 weeks
Percentage of Participants Adhering to DOR or to the FDC of DOR/3TC/TDF	Adherence to DOR or to the FDC of DOR/3TC/TDF will be monitored for up to 96 weeks.	Up to 96 weeks
Assessment of Palatability/Acceptability of Oral Pellets/Granules of DOR or the FDC of DOR/3TC/TDF	Palatability/acceptability will be based on scores on the 5-point facial hedonic scale (FHS). FHS scores will be tabulated and summarized by mean and standard deviation (SD), on Day 28. The highest possible FHS score is 5, with higher scores indicative of greater palatability.	Day 28

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2021
• Primary Completion (Estimated): November 12, 2028
• Study Completion (Estimated): April 11, 2034

Study Registration Dates

• First Submitted: May 4, 2020
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (Actual): May 5, 2020

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; doravirine
• Other Study ID Numbers: 1439-066; MK-1439-066 (Other Identifier: MSD); 2019-003955-13 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No