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NCT02778204

Evaluating the Safety and Pharmacokinetics of Maraviroc in HIV-1-Exposed Infants at Risk of Acquiring HIV-1 Infection

Completed Phase 1 Results posted Last updated 4 January 2022
What this trial tests

Phase 1 trial testing Maraviroc in HIV Infections in 47 participants. Completed in 20 November 2019.

Timeline
5 June 2017
Primary endpoint
6 September 2019
20 November 2019

Quick facts

Lead sponsorNational Institute of Allergy and Infectious Diseases (NIAID)
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment47
Start date5 June 2017
Primary completion6 September 2019
Estimated completion20 November 2019
Sites9 locations across South Africa, Kenya, United States, Thailand

Drugs / interventions tested

Conditions studied

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Under 3 Days, any sex, with HIV Infections. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants Failing to Meet Safety Endpoint Related to Maraviroc for Dose-Finding Primary · Cohort 1: Measured from first dose of maraviroc to 7 Day Post Dose Visit (up to 25 days). Cohort 2: Measured from first dose of maraviroc to Week 6 Visit (up to 42 days).

Percentage (%) of failure and Clopper-Pearson 95% Confidence Interval (CI). Failure is defined as having: Any life threatening adverse event (AE), including death, assessed as at least possibly related to the study drug, AEs of Grade 3 or higher judged by the Core Protocol Team to be probably or definitely related to the study drug, or that result in permanent discontinuation of study drug due to an AE, judged by Core Protocol Team to be at least possibly related to study drug

GroupValue95% CI
Cohort 1 Stratum 1A00 – 45.9
Cohort 1 Stratum 1B00 – 41.0
Cohort 2 Stratum 2A00 – 26.5
Cohort 2 Stratum 2B00 – 26.5
Percentage of Participants Failing to Meet Safety Endpoint Related to Maraviroc for Analysis Primary · Measured from first dose of maraviroc to Week 6 Visit (up to 42 days)

Percentage (%) of failure and Clopper-Pearson 95% CI. Failure is defined as: Any life threatening AE, including death, assessed as at least possibly related to the study drug, AEs of Grade 3 or higher judged by the Core Protocol Team to be probably or definitely related to the study drug, or that result in permanent discontinuation of study drug due to an AE, judged by Core Protocol Team to be at least possibly related to study drug

GroupValue95% CI
Cohort 1 Stratum 1A00 – 36.9
Cohort 1 Stratum 1B00 – 41.0
Cohort 2 Stratum 2A00 – 20.6
Cohort 2 Stratum 2B00 – 20.6
Number of Participants Failing to Meet PK Target Primary · Cohort 1: Measured at Entry (First visit) and Week 1 Visit (Second visit). Cohort 2: Measured at Week 1 (First visit) and Week 4 Visit (Second visit).

Number of failures. The pharmacokinetic (PK) target is Average Concentration (Cavg) greater than or equal to 75 ng/mL (based on a dose interval of every 12 hours). Failure is defined as Cavg \<75 ng/mL at each intensive PK visit. For Cohort 1: For the Entry Visit, PK samples were drawn at: pre-dose and at 1-2, 4-8, 11-13, 20-24, and 48-72 hours post-dose. For the Week 1 Visit, PK samples were drawn at: pre-dose and 1-2 and 22-26 hours post-dose. For Cohort 2: For both intensive PK visits, PK samples were drawn at: pre-dose and 1-2, 3-5, 6-8, and 11-13 hours post-dose.

First Visit
GroupValue95% CI
Cohort 1 Stratum 1A0
Cohort 1 Stratum 1B0
Cohort 2 Stratum 2A3
Cohort 2 Stratum 2B4
Second Visit
GroupValue95% CI
Cohort 2 Stratum 2A4
Cohort 2 Stratum 2B5
Pharmacokinetic (PK) Parameter: Average Concentration (Cavg) Primary · Cohort 1: Measured at Entry and Week 1 Visit. Cohort 2: Measured at Week 1 and Week 4 Visit

Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (Phoenix 64, WinNonlin, Pharsight Corp., Mountain View, CA). Cavg was determined as the area-under-the-curve (AUC) divided by the dose interval, tau (τ) of every 12 hours. For Cohort 1: For the Entry Visit, PK samples were drawn at: pre-dose and at 1-2, 4-8, 11-13, 20-24, and 48-72 hours post-dose. For the Week 1 Visit, PK samples were drawn at: pre-dose and 1-2 and 22-26 hours post-dose. For Cohort 2: For both intensive PK visits, PK samples were drawn at: pre-dose and 1-2, 3

First Visit
GroupValue95% CI
Cohort 1 Stratum 1A190.4793.54 – 1278.62
Cohort 1 Stratum 1B375.47110.40 – 684.84
Cohort 2 Stratum 2A152.2419.75 – 565.68
Cohort 2 Stratum 2B124.6717.07 – 550.86
Second Visit
GroupValue95% CI
Cohort 2 Stratum 2A93.5832.92 – 488.21
Cohort 2 Stratum 2B101.3942.65 – 351.19
Pharmacokinetic (PK) Parameter: Area-under-the-curve (AUC) Primary · Cohort 1: Measured at Entry (First visit) and Week 1 Visit (Second visit). Cohort 2: Measured at Week 1 (First visit) and Week 4 Visit (Second visit).

Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (Phoenix 64, WinNonlin, Pharsight Corp., Mountain View, CA). For Cohort 1 (single doses), area-under-the-curve (AUC) was determined from time zero to infinity. For Cohort 2 (at steady-state), area-under-the-curve (AUC) was determined from time pre-dose to tau (12 hours). For Cohort 1: For the Entry Visit, PK samples were drawn at: pre-dose and at 1-2, 4-8, 11-13, 20-24, and 48-72 hours post-dose. For the Week 1 Visit, PK samples were drawn at: pre-dose and 1-2 and 22-26 hours po

First Visit
GroupValue95% CI
Cohort 1 Stratum 1A2285.681122.53 – 15343.42
Cohort 1 Stratum 1B4506.171325.02 – 8218.03
Cohort 2 Stratum 2A1826.87236.96 – 6788.18
Cohort 2 Stratum 2B1496.05204.89 – 6610.35
Second Visit
GroupValue95% CI
Cohort 2 Stratum 2A1122.99395.01 – 5858.51
Cohort 2 Stratum 2B1216.62511.85 – 4214.34
Pharmacokinetic (PK) Parameter: Maximum Concentration (Cmax) Primary · Cohort 1: Measured at Entry (First visit) and Week 1 Visit (Second visit). Cohort 2: Measured at Week 1 (First visit) and Week 4 Visit (Second visit).

Pharmacokinetic parameters were determined from plasma concentration-time profiles. Cmax was the observed highest concentration. For Cohort 1: For the Entry Visit, PK samples were drawn at: pre-dose and at 1-2, 4-8, 11-13, 20-24, and 48-72 hours post-dose. For the Week 1 Visit, PK samples were drawn at: pre-dose and 1-2 and 22-26 hours post-dose. For Cohort 2: For both intensive PK visits, PK samples were drawn at: pre-dose and 1-2, 3-5, 6-8, and 11-13 hours post-dose.

First Visit
GroupValue95% CI
Cohort 1 Stratum 1A227.329.9 – 1618.4
Cohort 1 Stratum 1B550.5203.8 – 1153
Cohort 2 Stratum 2A256.951.5 – 1468.4
Cohort 2 Stratum 2B308.834.4 – 1273.5
Second Visit
GroupValue95% CI
Cohort 1 Stratum 1A128.922.8 – 296.2
Cohort 1 Stratum 1B163.48.7 – 609.4
Cohort 2 Stratum 2A416.5125.1 – 793.4
Cohort 2 Stratum 2B221.876.5 – 738.7
Pharmacokinetic (PK) Parameter: Time of Maximum Concentration (Tmax) Primary · Cohort 1: Measured at Entry (First visit) and Week 1 Visit (Second visit). Cohort 2: Measured at Week 1 (First visit) and Week 4 Visit (Second visit).

Pharmacokinetic parameters were determined from plasma concentration-time profiles. Tmax was the time at which Cmax, the observed highest concentration, occurred. For Cohort 1: For the Entry Visit, PK samples were drawn at: pre-dose and at 1-2, 4-8, 11-13, 20-24, and 48-72 hours post-dose. For the Week 1 Visit, PK samples were drawn at: pre-dose and 1-2 and 22-26 hours post-dose. For Cohort 2: For both intensive PK visits, PK samples were drawn at: pre-dose and 1-2, 3-5, 6-8, and 11-13 hours post-dose.

First Visit
GroupValue95% CI
Cohort 1 Stratum 1A4.681.05 – 12.75
Cohort 1 Stratum 1B1.521.25 – 4.42
Cohort 2 Stratum 2A1.500.83 – 4.00
Cohort 2 Stratum 2B3.001.00 – 6.18
Second Visit
GroupValue95% CI
Cohort 1 Stratum 1A1.181.05 – 1.25
Cohort 1 Stratum 1B1.081.07 – 1.33
Cohort 2 Stratum 2A1.501.00 – 4.00
Cohort 2 Stratum 2B2.190.00 – 11.43
Pharmacokinetic (PK) Parameter: Trough Concentration (Ctau) Primary · Measured at Week 1 and Week 4 Visit

Pharmacokinetic parameters were determined from plasma concentration-time profiles. Ctau was the observed concentration at the trough time of 12 hours post-dose with steady-state dosing. For Cohort 2: For both intensive PK visits, PK samples were drawn at: pre-dose and 1-2, 3-5, 6-8, and 11-13 hours post-dose.

Week 1 Visit
GroupValue95% CI
Cohort 2 Stratum 2A27.90 – 138.9
Cohort 2 Stratum 2B23.40 – 824.9
Week 4 Visit
GroupValue95% CI
Cohort 2 Stratum 2A34.40 – 373.1
Cohort 2 Stratum 2B54.98.2 – 233.9
Percentage of Participants Failing to Meet Long-Term Safety Endpoint Related to Maraviroc for Dose-Finding Secondary · Measured from first dose of maraviroc to Week 16 Visit (up to 140 days)

Percentage (%) of failure and Clopper-Pearson 95% CI. Failure is defined as having: Any life threatening AE, including death, assessed as at least possibly related to the study drug, AEs of Grade 3 or higher judged by the Core Protocol Team to be probably or definitely related to the study drug, or that result in permanent discontinuation of study drug due to an AE, judged by Core Protocol Team to be at least possibly related to study drug

GroupValue95% CI
Cohort 1 Stratum 1A00 – 45.9
Cohort 1 Stratum 1B00 – 41.0
Cohort 2 Stratum 2A00 – 26.5
Cohort 2 Stratum 2B00 – 26.5
Percentage of Participants Failing to Meet Long-Term Safety Endpoint Related to Maraviroc for Analysis Secondary · Measured from first dose of maraviroc to Week 16 Visit (up to 140 days)

Percentage (%) of failure and Clopper-Pearson 95% CI. Failure is defined as having: Any life threatening AE, including death, assessed as at least possibly related to the study drug, AEs of Grade 3 or higher judged by the Core Protocol Team to be probably or definitely related to the study drug, or that result in permanent discontinuation of study drug due to an AE, judged by Core Protocol Team to be at least possibly related to study drug

GroupValue95% CI
Cohort 1 Stratum 1A00 – 36.9
Cohort 1 Stratum 1B00 – 41.0
Cohort 2 Stratum 2A00 – 20.6
Cohort 2 Stratum 2B00 – 20.6

Adverse events — posted to ClinicalTrials.gov

Time frame: From study entry to study completion at Week 16 or premature study discontinuation. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cohort 1 Stratum 1A
Serious: 2/8 (25%)
Deaths: 0/8
Cohort 1 Stratum 1B
Serious: 1/7 (14%)
Deaths: 0/7
Cohort 2 Stratum 2A
Serious: 4/16 (25%)
Deaths: 0/16
Cohort 2 Stratum 2B
Serious: 2/16 (13%)
Deaths: 0/16

Serious adverse events (14 terms)

ReactionSystemCohort 1 Stratum 1ACohort 1 Stratum 1BCohort 2 Stratum 2ACohort 2 Stratum 2B
Haemolytic anaemiaBlood and lymphatic system disorders————
CyanosisCardiac disorders————
HypospadiasCongenital, familial and genetic disorders————
JaundiceHepatobiliary disorders————
Escherichia urinary tract infectionInfections and infestations————
Pneumonia bacterialInfections and infestations————
Sepsis neonatalInfections and infestations————
Staphylococcal sepsisInfections and infestations————
Haemoglobin decreasedInvestigations————
Neutrophil count decreasedInvestigations————
Weight decreasedInvestigations————
Failure to thriveMetabolism and nutrition disorders————
Slow response to stimuliNervous system disorders————
TremorNervous system disorders————
Other adverse events (77 terms — click to expand)

ReactionSystemCohort 1 Stratum 1ACohort 1 Stratum 1BCohort 2 Stratum 2ACohort 2 Stratum 2B
Haemoglobin decreasedInvestigations————
Blood bilirubin increasedInvestigations————
Neutrophil count decreasedInvestigations————
RashSkin and subcutaneous tissue disorders————
UnderweightMetabolism and nutrition disorders————
CoughRespiratory, thoracic and mediastinal disorders————
Eye dischargeEye disorders————
DiarrhoeaGastrointestinal disorders————
Aspartate aminotransferase increasedInvestigations————
Jaundice neonatalPregnancy, puerperium and perinatal conditions————
Nasal congestionRespiratory, thoracic and mediastinal disorders————
Rash neonatalSkin and subcutaneous tissue disorders————
TachycardiaCardiac disorders————
Feeling hotGeneral disorders————
PyrexiaGeneral disorders————
HyperbilirubinaemiaHepatobiliary disorders————
ImpetigoInfections and infestations————
Ophthalmia neonatorumInfections and infestations————
HypoxiaRespiratory, thoracic and mediastinal disorders————
RhinorrhoeaRespiratory, thoracic and mediastinal disorders————
SneezingRespiratory, thoracic and mediastinal disorders————
Dermatitis diaperSkin and subcutaneous tissue disorders————
MiliariaSkin and subcutaneous tissue disorders————
PapuleSkin and subcutaneous tissue disorders————
Haemolytic anaemiaBlood and lymphatic system disorders————
Congenital melanocytic naevusCongenital, familial and genetic disorders————
Congenital syphilisCongenital, familial and genetic disorders————
HypospadiasCongenital, familial and genetic disorders————
Conjunctival pallorEye disorders————
Ocular hyperaemiaEye disorders————
Orbital oedemaEye disorders————
Abdominal distensionGastrointestinal disorders————
Abdominal painGastrointestinal disorders————
Infantile colicGastrointestinal disorders————
Infantile vomitingGastrointestinal disorders————
Mouth ulcerationGastrointestinal disorders————
TeethingGastrointestinal disorders————
Face oedemaGeneral disorders————
Hyperbilirubinaemia neonatalHepatobiliary disorders————
JaundiceHepatobiliary disorders————

Most-reported serious reactions: Haemolytic anaemia, Cyanosis, Hypospadias, Jaundice, Escherichia urinary tract infection, Pneumonia bacterial, Sepsis neonatal, Staphylococcal sepsis.

Data from ClinicalTrials.gov NCT02778204 adverse events section.

Sponsor's own description

This study aimed to evaluate the safety, tolerability, and pharmacokinetics of maraviroc in infants at risk for mother-to-child HIV transmission, and to determine an appropriate dose of maraviroc during the first six weeks of life.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other trials of Maraviroc

Trials testing the same drug.

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Trials by the same sponsor.

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