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

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ClinicalTrials.gov Identifier: NCT02778204
Recruitment Status : Completed
First Posted : May 19, 2016
Results First Posted : November 23, 2020
Last Update Posted : November 23, 2020
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ViiV Healthcare
GlaxoSmithKline
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition HIV Infections
Intervention Drug: Maraviroc
Enrollment 47
Recruitment Details Accrual occurred between June 2017 and July 2019 in Kenya, Thailand, South Africa, and the United States at 9 different medical clinic sites. Pregnant mothers were screened and subsequently enrolled for 1 day at the same day their newborn infants were enrolled (within 3 days of life).
Pre-assignment Details The sample size of the study (47) represents the infants enrolled. As multiple births are disallowed in the study, this also represents the total mother-infant pairs.
Arm/Group Title Cohort 1 Stratum 1A Cohort 1 Stratum 1B Cohort 2 Stratum 2A Cohort 2 Stratum 2B
Hide Arm/Group Description Infants in this cohort received a single dose of 8 mg/kg maraviroc solution within 3 days of birth and at Week 1 (7-14 days) of life; without in utero exposure to maternal efavirenz. Infants in this cohort received a single dose of 8 mg/kg maraviroc solution within 3 days of birth and at Week 1 (7-14 days) of life; with in utero exposure to maternal efavirenz. Infants in this cohort received 8 mg/kg maraviroc solution twice daily starting within 3 days of birth and continuing up to Week 6 (35-42) days of life; without in utero or breast milk exposure to maternal efavirenz. Infants in this cohort received 8 mg/kg maraviroc solution twice daily starting within 3 days of birth and continuing up to Week 6 (35-42) days of life; with in utero and breast milk exposure to maternal efavirenz
Period Title: Overall Study
Started 8 7 16 16
Completed 6 7 12 12
Not Completed 2 0 4 4
Reason Not Completed
Adverse Event             1             0             0             0
Withdrawal by Subject             0             0             1             2
Lost to Follow-up             1             0             2             1
Protocol Violation             0             0             1             0
Eligibility Violation             0             0             0             1
Arm/Group Title Cohort 1 Stratum 1A Cohort 1 Stratum 1B Cohort 2 Stratum 2A Cohort 2 Stratum 2B Total
Hide Arm/Group Description Infants in this cohort received a single dose of 8 mg/kg maraviroc solution within 3 days of birth and at Week 1 (7-14 days) of life; without in utero exposure to maternal efavirenz. Infants in this cohort received a single dose of 8 mg/kg maraviroc solution within 3 days of birth and at Week 1 (7-14 days) of life; with in utero exposure to maternal efavirenz. Infants in this cohort received 8 mg/kg maraviroc solution twice daily starting within 3 days of birth and continuing up to Week 6 (35-42) days of life; without in utero or breast milk exposure to maternal efavirenz. Infants in this cohort received 8 mg/kg maraviroc solution twice daily starting within 3 days of birth and continuing up to Week 6 (35-42) days of life; with in utero and breast milk exposure to maternal efavirenz Total of all reporting groups
Overall Number of Baseline Participants 8 7 16 16 47
Hide Baseline Analysis Population Description
Includes all infants.
Age, Continuous   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Days
Mean (Standard Deviation) Number Analyzed 8 participants 7 participants 16 participants 16 participants 47 participants
1.5
(1 to 2)
0
(0 to 1)
1
(0 to 2)
2
(2 to 3)
2
(1 to 2)
[1]
Measure Description: This is the Infant age at baseline.
Age, Continuous   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 8 participants 7 participants 16 participants 16 participants 47 participants
29.5
(29 to 37)
26
(24 to 39)
32
(26.5 to 36)
32
(27.5 to 37.5)
31
(26 to 37)
[1]
Measure Description: This is the Maternal Age at baseline.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 7 participants 16 participants 16 participants 47 participants
Female
5
  62.5%
4
  57.1%
7
  43.8%
7
  43.8%
23
  48.9%
Male
3
  37.5%
3
  42.9%
9
  56.3%
9
  56.3%
24
  51.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 7 participants 16 participants 16 participants 47 participants
Hispanic or Latino
3
  37.5%
0
   0.0%
2
  12.5%
0
   0.0%
5
  10.6%
Not Hispanic or Latino
5
  62.5%
7
 100.0%
14
  87.5%
16
 100.0%
42
  89.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 7 participants 16 participants 16 participants 47 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
3
  18.8%
0
   0.0%
3
   6.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
5
  62.5%
7
 100.0%
10
  62.5%
16
 100.0%
38
  80.9%
White
3
  37.5%
0
   0.0%
3
  18.8%
0
   0.0%
6
  12.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 8 participants 7 participants 16 participants 16 participants 47 participants
United States 7 0 13 0 20
South Africa 1 7 0 14 22
Thailand 0 0 3 0 3
Kenya 0 0 0 2 2
Birth Weight  
Median (Inter-Quartile Range)
Unit of measure:  Kilograms
Number Analyzed 8 participants 7 participants 16 participants 16 participants 47 participants
3.2
(2.8 to 3.5)
3.4
(2.9 to 3.64)
3.0
(2.9 to 3.19)
3.0
(2.8 to 3.16)
3.05
(2.9 to 3.4)
Birth Length  
Median (Inter-Quartile Range)
Unit of measure:  Centimeters
Number Analyzed 8 participants 7 participants 16 participants 16 participants 47 participants
50.0
(49.0 to 51.25)
50.0
(48.5 to 51.0)
49.0
(49.0 to 50.5)
48.5
(47.5 to 50.45)
49.0
(48.0 to 51.0)
Gestational Age  
Median (Inter-Quartile Range)
Unit of measure:  Weeks
Number Analyzed 8 participants 7 participants 16 participants 16 participants 47 participants
38.5
(38.0 to 39.5)
39.0
(38.0 to 39.0)
39.0
(38.0 to 39.5)
40.0
(39.0 to 40.5)
39.0
(38.0 to 40.0)
APGAR at 1 minute   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 8 participants 7 participants 16 participants 16 participants 47 participants
9.0
(9.0 to 9.0)
8.0
(8.0 to 8.0)
8.5
(8.0 to 9.0)
9.0
(8.0 to 9.0)
9.0
(8.0 to 9.0)
[1]
Measure Description: APGAR Score ranges from 1-10, with 1 being the worst and 10 being the best.
Alanine Aminotransferase (ALT)  
Median (Inter-Quartile Range)
Unit of measure:  ukat/L
Number Analyzed 8 participants 7 participants 16 participants 16 participants 47 participants
0.2
(0.1 to 0.23)
0.2
(0.2 to 0.28)
0.2
(0.1 to 0.25)
0.2
(0.1 to 0.24)
0.2
(0.1 to 0.25)
Aspartate Aminotransferase (AST)  
Median (Inter-Quartile Range)
Unit of measure:  ukat/L
Number Analyzed 8 participants 7 participants 16 participants 16 participants 47 participants
0.7
(0.5 to 0.91)
1.1
(0.9 to 3.46)
0.9
(0.6 to 1.08)
1.0
(0.7 to 1.27)
0.9
(0.7 to 1.15)
Total Bilirubin  
Median (Inter-Quartile Range)
Unit of measure:  umol/L
Number Analyzed 8 participants 7 participants 16 participants 16 participants 47 participants
39.3
(30.8 to 74.8)
44.0
(25.0 to 49.0)
76.1
(41.0 to 129.1)
75.3
(41.6 to 105.3)
50.7
(35.9 to 99.2)
Creatinine  
Median (Inter-Quartile Range)
Unit of measure:  umol/L
Number Analyzed 8 participants 7 participants 16 participants 16 participants 47 participants
70.7
(54.4 to 78.7)
62.0
(54.0 to 63.0)
61.9
(49.5 to 70.7)
69.0
(44.0 to 73.0)
66
(49.5 to 72.0)
Platelets  
Median (Inter-Quartile Range)
Unit of measure:  10^9 platelets/L
Number Analyzed 8 participants 7 participants 16 participants 16 participants 47 participants
274.0
(247.0 to 335.5)
297.0
(272.0 to 380.0)
252.5
(161.5 to 307.5)
311.0
(261.0 to 383.5)
289.0
(241.0 to 360.0)
Hemoglobin  
Median (Inter-Quartile Range)
Unit of measure:  g/L
Number Analyzed 8 participants 7 participants 16 participants 16 participants 47 participants
163.0
(158.5 to 166.5)
178.0
(171.0 to 216.0)
166.5
(152.5 to 174.0)
179.0
(165.5 to 205.5)
170.0
(161.0 to 194.0)
White Blood Cell Count (WBC)  
Median (Inter-Quartile Range)
Unit of measure:  10^9 cells/L
Number Analyzed 8 participants 7 participants 16 participants 16 participants 47 participants
14.6
(12.0 to 19.65)
17.3
(12.9 to 19.3)
15.5
(12.2 to 20.0)
12.6
(10.6 to 15.7)
14.6
(11.3 to 17.4)
1.Primary Outcome
Title Percentage of Participants Failing to Meet Safety Endpoint Related to Maraviroc for Dose-Finding
Hide Description 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
Time Frame 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).
Hide Outcome Measure Data
Hide Analysis Population Description
Safety-evaluable population are those who were taking maraviroc for the expected time-frame (Cohort 1: through 7 day post-dose visit, Cohort 2: Through week 6)
Arm/Group Title Cohort 1 Stratum 1A Cohort 1 Stratum 1B Cohort 2 Stratum 2A Cohort 2 Stratum 2B
Hide Arm/Group Description:
Infants in this cohort received a single dose of 8 mg/kg maraviroc solution within 3 days of birth and at Week 1 (7-14 days) of life; without in utero exposure to maternal efavirenz.
Infants in this cohort received a single dose of 8 mg/kg maraviroc solution within 3 days of birth and at Week 1 (7-14 days) of life; with in utero exposure to maternal efavirenz.
Infants in this cohort received 8 mg/kg maraviroc solution twice daily starting within 3 days of birth and continuing up to Week 6 (35-42) days of life; without in utero or breast milk exposure to maternal efavirenz.
Infants in this cohort received 8 mg/kg maraviroc solution twice daily starting within 3 days of birth and continuing up to Week 6 (35-42) days of life; with in utero and breast milk exposure to maternal efavirenz
Overall Number of Participants Analyzed 6 7 12 12
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0 to 45.9)
0
(0 to 41.0)
0
(0 to 26.5)
0
(0 to 26.5)
2.Primary Outcome
Title Percentage of Participants Failing to Meet Safety Endpoint Related to Maraviroc for Analysis
Hide Description 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
Time Frame Measured from first dose of maraviroc to Week 6 Visit (up to 42 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis Endpoint includes all treated participants
Arm/Group Title Cohort 1 Stratum 1A Cohort 1 Stratum 1B Cohort 2 Stratum 2A Cohort 2 Stratum 2B
Hide Arm/Group Description:
Infants in this cohort received a single dose of 8 mg/kg maraviroc solution within 3 days of birth and at Week 1 (7-14 days) of life; without in utero exposure to maternal efavirenz.
Infants in this cohort received a single dose of 8 mg/kg maraviroc solution within 3 days of birth and at Week 1 (7-14 days) of life; with in utero exposure to maternal efavirenz.
Infants in this cohort received 8 mg/kg maraviroc solution twice daily starting within 3 days of birth and continuing up to Week 6 (35-42) days of life; without in utero or breast milk exposure to maternal efavirenz.
Infants in this cohort received 8 mg/kg maraviroc solution twice daily starting within 3 days of birth and continuing up to Week 6 (35-42) days of life; with in utero and breast milk exposure to maternal efavirenz
Overall Number of Participants Analyzed 8 7 16 16
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0 to 36.9)
0
(0 to 41.0)
0
(0 to 20.6)
0
(0 to 20.6)
3.Primary Outcome
Title Number of Participants Failing to Meet PK Target
Hide Description

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.

Time Frame 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).
Hide Outcome Measure Data
Hide Analysis Population Description

Analysis population included dose-finding evaluable participants with intensive pharmacokinetic (PK) results.

In Cohort 1 Stratum 1A and 1B at the week 1 visit (Second Visit), only 3 PK sample were drawn (pre-dose, 1-2 hours post-dose, and 22-26 hours post-dose). Maraviroc was only measurable (above assay limit) at 1 time point (1-2 hours post-dose). Therefore, AUC (hence Cavg) could not be estimated with non-compartmental methods from only 1 concentration and thus the number analyzed was 0.

Arm/Group Title Cohort 1 Stratum 1A Cohort 1 Stratum 1B Cohort 2 Stratum 2A Cohort 2 Stratum 2B
Hide Arm/Group Description:
Infants in this cohort received a single dose of 8 mg/kg maraviroc solution within 3 days of birth and at Week 1 (7-14 days) of life; without in utero exposure to maternal efavirenz.
Infants in this cohort received a single dose of 8 mg/kg maraviroc solution within 3 days of birth and at Week 1 (7-14 days) of life; with in utero exposure to maternal efavirenz.
Infants in this cohort received 8 mg/kg maraviroc solution twice daily starting within 3 days of birth and continuing up to Week 6 (35-42) days of life; without in utero or breast milk exposure to maternal efavirenz.
Infants in this cohort received 8 mg/kg maraviroc solution twice daily starting within 3 days of birth and continuing up to Week 6 (35-42) days of life; with in utero and breast milk exposure to maternal efavirenz
Overall Number of Participants Analyzed 6 7 13 12
Measure Type: Number
Unit of Measure: participants
First Visit Number Analyzed 6 participants 7 participants 13 participants 12 participants
0 0 3 4
Second Visit Number Analyzed 0 participants 0 participants 13 participants 12 participants
4 5
4.Primary Outcome
Title Pharmacokinetic (PK) Parameter: Average Concentration (Cavg)
Hide Description

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, 3-5, 6-8, and 11-13 hours post-dose.

Time Frame Cohort 1: Measured at Entry and Week 1 Visit. Cohort 2: Measured at Week 1 and Week 4 Visit
Hide Outcome Measure Data
Hide Analysis Population Description

Analysis population included dose-finding evaluable participants with intensive pharmacokinetic (PK) results.

In Cohort 1 Stratum 1A and 1B at the week 1 visit (Second Visit), only 3 PK sample were drawn (pre-dose, 1-2 hours post-dose, and 22-26 hours post-dose). Maraviroc was only measurable (above assay limit) at 1 time point (1-2 hours post-dose). Therefore, AUC (hence Cavg) could not be estimated with non-compartmental methods from only 1 concentration and thus the number analyzed was 0.

Arm/Group Title Cohort 1 Stratum 1A Cohort 1 Stratum 1B Cohort 2 Stratum 2A Cohort 2 Stratum 2B
Hide Arm/Group Description:
Infants in this cohort received a single dose of 8 mg/kg maraviroc solution within 3 days of birth and at Week 1 (7-14 days) of life; without in utero exposure to maternal efavirenz.
Infants in this cohort received a single dose of 8 mg/kg maraviroc solution within 3 days of birth and at Week 1 (7-14 days) of life; with in utero exposure to maternal efavirenz.
Infants in this cohort received 8 mg/kg maraviroc solution twice daily starting within 3 days of birth and continuing up to Week 6 (35-42) days of life; without in utero or breast milk exposure to maternal efavirenz.
Infants in this cohort received 8 mg/kg maraviroc solution twice daily starting within 3 days of birth and continuing up to Week 6 (35-42) days of life; with in utero and breast milk exposure to maternal efavirenz
Overall Number of Participants Analyzed 6 7 13 12
Median (Full Range)
Unit of Measure: ng/mL
First Visit Number Analyzed 6 participants 7 participants 13 participants 12 participants
190.47
(93.54 to 1278.62)
375.47
(110.40 to 684.84)
152.24
(19.75 to 565.68)
124.67
(17.07 to 550.86)
Second Visit Number Analyzed 0 participants 0 participants 13 participants 12 participants
93.58
(32.92 to 488.21)
101.39
(42.65 to 351.19)
5.Primary Outcome
Title Pharmacokinetic (PK) Parameter: Area-under-the-curve (AUC)
Hide Description

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 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.

Time Frame 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).
Hide Outcome Measure Data
Hide Analysis Population Description

Analysis population included dose-finding evaluable participants with intensive pharmacokinetic (PK) results.

In Cohort 1 Stratum 1A and 1B at the week 1 visit (Second Visit), only 3 PK sample were drawn (pre-dose, 1-2 hours post-dose, and 22-26 hours post-dose). Maraviroc was only measurable (above assay limit) at 1 time point (1-2 hours post-dose). Therefore, AUC (hence Cavg) could not be estimated with non-compartmental methods from only 1 concentration and thus the number analyzed was 0.

Arm/Group Title Cohort 1 Stratum 1A Cohort 1 Stratum 1B Cohort 2 Stratum 2A Cohort 2 Stratum 2B
Hide Arm/Group Description:
Infants in this cohort received a single dose of 8 mg/kg maraviroc solution within 3 days of birth and at Week 1 (7-14 days) of life; without in utero exposure to maternal efavirenz.
Infants in this cohort received a single dose of 8 mg/kg maraviroc solution within 3 days of birth and at Week 1 (7-14 days) of life; with in utero exposure to maternal efavirenz.
Infants in this cohort received 8 mg/kg maraviroc solution twice daily starting within 3 days of birth and continuing up to Week 6 (35-42) days of life; without in utero or breast milk exposure to maternal efavirenz.
Infants in this cohort received 8 mg/kg maraviroc solution twice daily starting within 3 days of birth and continuing up to Week 6 (35-42) days of life; with in utero and breast milk exposure to maternal efavirenz
Overall Number of Participants Analyzed 6 7 13 12
Median (Full Range)
Unit of Measure: ng*hr/mL
First Visit Number Analyzed 6 participants 7 participants 13 participants 12 participants
2285.68
(1122.53 to 15343.42)
4506.17
(1325.02 to 8218.03)
1826.87
(236.96 to 6788.18)
1496.05
(204.89 to 6610.35)
Second Visit Number Analyzed 0 participants 0 participants 13 participants 12 participants
1122.99
(395.01 to 5858.51)
1216.62
(511.85 to 4214.34)
6.Primary Outcome
Title Pharmacokinetic (PK) Parameter: Maximum Concentration (Cmax)
Hide Description

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.

Time Frame 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).
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included dose-finding evaluable participants with intensive pharmacokinetic (PK) results.
Arm/Group Title Cohort 1 Stratum 1A Cohort 1 Stratum 1B Cohort 2 Stratum 2A Cohort 2 Stratum 2B
Hide Arm/Group Description:
Infants in this cohort received a single dose of 8 mg/kg maraviroc solution within 3 days of birth and at Week 1 (7-14 days) of life; without in utero exposure to maternal efavirenz.
Infants in this cohort received a single dose of 8 mg/kg maraviroc solution within 3 days of birth and at Week 1 (7-14 days) of life; with in utero exposure to maternal efavirenz.
Infants in this cohort received 8 mg/kg maraviroc solution twice daily starting within 3 days of birth and continuing up to Week 6 (35-42) days of life; without in utero or breast milk exposure to maternal efavirenz.
Infants in this cohort received 8 mg/kg maraviroc solution twice daily starting within 3 days of birth and continuing up to Week 6 (35-42) days of life; with in utero and breast milk exposure to maternal efavirenz
Overall Number of Participants Analyzed 6 7 13 12
Median (Full Range)
Unit of Measure: ng/mL
First Visit
227.3
(29.9 to 1618.4)
550.5
(203.8 to 1153)
256.9
(51.5 to 1468.4)
308.8
(34.4 to 1273.5)
Second Visit
128.9
(22.8 to 296.2)
163.4
(8.7 to 609.4)
416.5
(125.1 to 793.4)
221.8
(76.5 to 738.7)
7.Primary Outcome
Title Pharmacokinetic (PK) Parameter: Time of Maximum Concentration (Tmax)
Hide Description

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.

Time Frame 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).
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included dose-finding evaluable participants with intensive pharmacokinetic (PK) results.
Arm/Group Title Cohort 1 Stratum 1A Cohort 1 Stratum 1B Cohort 2 Stratum 2A Cohort 2 Stratum 2B
Hide Arm/Group Description:
Infants in this cohort received a single dose of 8 mg/kg maraviroc solution within 3 days of birth and at Week 1 (7-14 days) of life; without in utero exposure to maternal efavirenz.
Infants in this cohort received a single dose of 8 mg/kg maraviroc solution within 3 days of birth and at Week 1 (7-14 days) of life; with in utero exposure to maternal efavirenz.
Infants in this cohort received 8 mg/kg maraviroc solution twice daily starting within 3 days of birth and continuing up to Week 6 (35-42) days of life; without in utero or breast milk exposure to maternal efavirenz.
Infants in this cohort received 8 mg/kg maraviroc solution twice daily starting within 3 days of birth and continuing up to Week 6 (35-42) days of life; with in utero and breast milk exposure to maternal efavirenz
Overall Number of Participants Analyzed 6 7 13 12
Median (Full Range)
Unit of Measure: hours
First Visit
4.68
(1.05 to 12.75)
1.52
(1.25 to 4.42)
1.50
(0.83 to 4.00)
3.00
(1.00 to 6.18)
Second Visit
1.18
(1.05 to 1.25)
1.08
(1.07 to 1.33)
1.50
(1.00 to 4.00)
2.19
(0.00 to 11.43)
8.Primary Outcome
Title Pharmacokinetic (PK) Parameter: Trough Concentration (Ctau)
Hide Description

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.

Time Frame Measured at Week 1 and Week 4 Visit
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population included Cohort 2 dose-finding evaluable participants with intensive pharmacokinetic (PK) results.
Arm/Group Title Cohort 2 Stratum 2A Cohort 2 Stratum 2B
Hide Arm/Group Description:
Infants in this cohort received 8 mg/kg maraviroc solution twice daily starting within 3 days of birth and continuing up to Week 6 (35-42) days of life; without in utero or breast milk exposure to maternal efavirenz.
Infants in this cohort received 8 mg/kg maraviroc solution twice daily starting within 3 days of birth and continuing up to Week 6 (35-42) days of life; with in utero and breast milk exposure to maternal efavirenz
Overall Number of Participants Analyzed 13 12
Median (Full Range)
Unit of Measure: ng/mL
Week 1 Visit
27.9
(0 to 138.9)
23.4
(0 to 824.9)
Week 4 Visit
34.4
(0 to 373.1)
54.9
(8.2 to 233.9)
9.Secondary Outcome
Title Percentage of Participants Failing to Meet Long-Term Safety Endpoint Related to Maraviroc for Dose-Finding
Hide Description 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
Time Frame Measured from first dose of maraviroc to Week 16 Visit (up to 140 days)
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Hide Analysis Population Description
Safety-evaluable population are those who were taking maraviroc for the expected time-frame (Cohort 1: through 7 day post-dose visit, Cohort 2: Through week 6)
Arm/Group Title Cohort 1 Stratum 1A Cohort 1 Stratum 1B Cohort 2 Stratum 2A Cohort 2 Stratum 2B
Hide Arm/Group Description:
Infants in this cohort received a single dose of 8 mg/kg maraviroc solution within 3 days of birth and at Week 1 (7-14 days) of life; without in utero exposure to maternal efavirenz.
Infants in this cohort received a single dose of 8 mg/kg maraviroc solution within 3 days of birth and at Week 1 (7-14 days) of life; with in utero exposure to maternal efavirenz.
Infants in this cohort received 8 mg/kg maraviroc solution twice daily starting within 3 days of birth and continuing up to Week 6 (35-42) days of life; without in utero or breast milk exposure to maternal efavirenz.
Infants in this cohort received 8 mg/kg maraviroc solution twice daily starting within 3 days of birth and continuing up to Week 6 (35-42) days of life; with in utero and breast milk exposure to maternal efavirenz
Overall Number of Participants Analyzed 6 7 12 12
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0 to 45.9)
0
(0 to 41.0)
0
(0 to 26.5)
0
(0 to 26.5)
10.Secondary Outcome
Title Percentage of Participants Failing to Meet Long-Term Safety Endpoint Related to Maraviroc for Analysis
Hide Description 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
Time Frame Measured from first dose of maraviroc to Week 16 Visit (up to 140 days)
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Hide Analysis Population Description
All treated participants
Arm/Group Title Cohort 1 Stratum 1A Cohort 1 Stratum 1B Cohort 2 Stratum 2A Cohort 2 Stratum 2B
Hide Arm/Group Description:
Infants in this cohort received a single dose of 8 mg/kg maraviroc solution within 3 days of birth and at Week 1 (7-14 days) of life; without in utero exposure to maternal efavirenz.
Infants in this cohort received a single dose of 8 mg/kg maraviroc solution within 3 days of birth and at Week 1 (7-14 days) of life; with in utero exposure to maternal efavirenz.
Infants in this cohort received 8 mg/kg maraviroc solution twice daily starting within 3 days of birth and continuing up to Week 6 (35-42) days of life; without in utero or breast milk exposure to maternal efavirenz.
Infants in this cohort received 8 mg/kg maraviroc solution twice daily starting within 3 days of birth and continuing up to Week 6 (35-42) days of life; with in utero and breast milk exposure to maternal efavirenz
Overall Number of Participants Analyzed 8 7 16 16
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0 to 36.9)
0
(0 to 41.0)
0
(0 to 20.6)
0
(0 to 20.6)
Time Frame From study entry to study completion at Week 16 or premature study discontinuation
Adverse Event Reporting Description All new diagnoses, signs/symptoms and laboratory events of ≥Grade 1 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade, were collected. Adverse events (AE) were graded according to the 246 Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, dated July 2017
 
Arm/Group Title Cohort 1 Stratum 1A Cohort 1 Stratum 1B Cohort 2 Stratum 2A Cohort 2 Stratum 2B
Hide Arm/Group Description Infants in this cohort received a single dose of 8 mg/kg maraviroc solution within 3 days of birth and at Week 1 (7-14 days) of life; without in utero exposure to maternal efavirenz. Infants in this cohort received a single dose of 8 mg/kg maraviroc solution within 3 days of birth and at Week 1 (7-14 days) of life; with in utero exposure to maternal efavirenz. Infants in this cohort received 8 mg/kg maraviroc solution twice daily starting within 3 days of birth and continuing up to Week 6 (35-42) days of life; without in utero or breast milk exposure to maternal efavirenz. Infants in this cohort received 8 mg/kg maraviroc solution twice daily starting within 3 days of birth and continuing up to Week 6 (35-42) days of life; with in utero and breast milk exposure to maternal efavirenz
All-Cause Mortality
Cohort 1 Stratum 1A Cohort 1 Stratum 1B Cohort 2 Stratum 2A Cohort 2 Stratum 2B
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/7 (0.00%)   0/16 (0.00%)   0/16 (0.00%) 
Hide Serious Adverse Events
Cohort 1 Stratum 1A Cohort 1 Stratum 1B Cohort 2 Stratum 2A Cohort 2 Stratum 2B
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/8 (25.00%)   1/7 (14.29%)   4/16 (25.00%)   2/16 (12.50%) 
Blood and lymphatic system disorders         
Haemolytic anaemia  1  0/8 (0.00%)  0/7 (0.00%)  0/16 (0.00%)  1/16 (6.25%) 
Cardiac disorders         
Cyanosis  1  1/8 (12.50%)  0/7 (0.00%)  0/16 (0.00%)  0/16 (0.00%) 
Congenital, familial and genetic disorders         
Hypospadias  1  0/8 (0.00%)  1/7 (14.29%)  0/16 (0.00%)  0/16 (0.00%) 
Hepatobiliary disorders         
Jaundice  1  0/8 (0.00%)  0/7 (0.00%)  0/16 (0.00%)  1/16 (6.25%) 
Infections and infestations         
Escherichia urinary tract infection  1  0/8 (0.00%)  0/7 (0.00%)  0/16 (0.00%)  1/16 (6.25%) 
Pneumonia bacterial  1  0/8 (0.00%)  0/7 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
Sepsis neonatal  1  0/8 (0.00%)  0/7 (0.00%)  0/16 (0.00%)  1/16 (6.25%) 
Staphylococcal sepsis  1  1/8 (12.50%)  0/7 (0.00%)  0/16 (0.00%)  0/16 (0.00%) 
Investigations         
Haemoglobin decreased  1  0/8 (0.00%)  0/7 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
Neutrophil count decreased  1  0/8 (0.00%)  0/7 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
Weight decreased  1  0/8 (0.00%)  0/7 (0.00%)  0/16 (0.00%)  1/16 (6.25%) 
Metabolism and nutrition disorders         
Failure to thrive  1  0/8 (0.00%)  0/7 (0.00%)  1/16 (6.25%)  1/16 (6.25%) 
Nervous system disorders         
Slow response to stimuli  1  1/8 (12.50%)  0/7 (0.00%)  0/16 (0.00%)  0/16 (0.00%) 
Tremor  1  1/8 (12.50%)  0/7 (0.00%)  0/16 (0.00%)  0/16 (0.00%) 
1
Term from vocabulary, MedDRA 21.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cohort 1 Stratum 1A Cohort 1 Stratum 1B Cohort 2 Stratum 2A Cohort 2 Stratum 2B
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/8 (87.50%)   7/7 (100.00%)   15/16 (93.75%)   14/16 (87.50%) 
Blood and lymphatic system disorders         
Haemolytic anaemia  1  0/8 (0.00%)  0/7 (0.00%)  0/16 (0.00%)  1/16 (6.25%) 
Cardiac disorders         
Tachycardia  1  0/8 (0.00%)  0/7 (0.00%)  2/16 (12.50%)  0/16 (0.00%) 
Congenital, familial and genetic disorders         
Congenital melanocytic naevus  1  1/8 (12.50%)  0/7 (0.00%)  0/16 (0.00%)  0/16 (0.00%) 
Congenital syphilis  1  0/8 (0.00%)  0/7 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
Hypospadias  1  0/8 (0.00%)  1/7 (14.29%)  0/16 (0.00%)  0/16 (0.00%) 
Eye disorders         
Conjunctival pallor  1  0/8 (0.00%)  1/7 (14.29%)  0/16 (0.00%)  1/16 (6.25%) 
Eye discharge  1  1/8 (12.50%)  1/7 (14.29%)  0/16 (0.00%)  3/16 (18.75%) 
Ocular hyperaemia  1  0/8 (0.00%)  0/7 (0.00%)  0/16 (0.00%)  1/16 (6.25%) 
Orbital oedema  1  0/8 (0.00%)  0/7 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
Gastrointestinal disorders         
Abdominal distension  1  0/8 (0.00%)  0/7 (0.00%)  0/16 (0.00%)  1/16 (6.25%) 
Abdominal pain  1  0/8 (0.00%)  0/7 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
Diarrhoea  1  0/8 (0.00%)  1/7 (14.29%)  3/16 (18.75%)  0/16 (0.00%) 
Infantile colic  1  0/8 (0.00%)  0/7 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
Infantile vomiting  1  0/8 (0.00%)  0/7 (0.00%)  0/16 (0.00%)  1/16 (6.25%) 
Mouth ulceration  1  0/8 (0.00%)  1/7 (14.29%)  0/16 (0.00%)  0/16 (0.00%) 
Teething  1  0/8 (0.00%)  0/7 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
General disorders         
Face oedema  1  0/8 (0.00%)  0/7 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
Feeling hot  1  0/8 (0.00%)  0/7 (0.00%)  0/16 (0.00%)  2/16 (12.50%) 
Pyrexia  1  0/8 (0.00%)  1/7 (14.29%)  2/16 (12.50%)  1/16 (6.25%) 
Hepatobiliary disorders         
Hyperbilirubinaemia  1  0/8 (0.00%)  0/7 (0.00%)  2/16 (12.50%)  0/16 (0.00%) 
Hyperbilirubinaemia neonatal  1  0/8 (0.00%)  0/7 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
Jaundice  1  0/8 (0.00%)  0/7 (0.00%)  0/16 (0.00%)  1/16 (6.25%) 
Infections and infestations         
Acarodermatitis  1  0/8 (0.00%)  1/7 (14.29%)  0/16 (0.00%)  0/16 (0.00%) 
Conjunctivitis bacterial  1  1/8 (12.50%)  0/7 (0.00%)  0/16 (0.00%)  0/16 (0.00%) 
Escherichia urinary tract infection  1  0/8 (0.00%)  0/7 (0.00%)  0/16 (0.00%)  1/16 (6.25%) 
Genital candidiasis  1  0/8 (0.00%)  0/7 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
Impetigo  1  0/8 (0.00%)  2/7 (28.57%)  0/16 (0.00%)  0/16 (0.00%) 
Nasopharyngitis  1  0/8 (0.00%)  0/7 (0.00%)  0/16 (0.00%)  1/16 (6.25%) 
Ophthalmia neonatorum  1  1/8 (12.50%)  0/7 (0.00%)  1/16 (6.25%)  2/16 (12.50%) 
Oral candidiasis  1  1/8 (12.50%)  0/7 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
Pneumonia bacterial  1  0/8 (0.00%)  0/7 (0.00%)  1/16 (6.25%)  1/16 (6.25%) 
Sepsis neonatal  1  0/8 (0.00%)  0/7 (0.00%)  0/16 (0.00%)  1/16 (6.25%) 
Staphylococcal sepsis  1  1/8 (12.50%)  0/7 (0.00%)  0/16 (0.00%)  0/16 (0.00%) 
Tinea versicolour  1  0/8 (0.00%)  0/7 (0.00%)  0/16 (0.00%)  1/16 (6.25%) 
Injury, poisoning and procedural complications         
Contusion  1  0/8 (0.00%)  0/7 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
Eyelid injury  1  0/8 (0.00%)  0/7 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
Investigations         
Alanine aminotransferase increased  1  0/8 (0.00%)  1/7 (14.29%)  0/16 (0.00%)  1/16 (6.25%) 
Aspartate aminotransferase increased  1  1/8 (12.50%)  0/7 (0.00%)  0/16 (0.00%)  3/16 (18.75%) 
Bilirubin conjugated increased  1  0/8 (0.00%)  0/7 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
Blood bilirubin increased  1  2/8 (25.00%)  0/7 (0.00%)  9/16 (56.25%)  4/16 (25.00%) 
Blood potassium increased  1  0/8 (0.00%)  0/7 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
Cardiac murmur  1  0/8 (0.00%)  0/7 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
Haemoglobin decreased  1  4/8 (50.00%)  4/7 (57.14%)  11/16 (68.75%)  5/16 (31.25%) 
Neutrophil count decreased  1  0/8 (0.00%)  2/7 (28.57%)  5/16 (31.25%)  7/16 (43.75%) 
Weight decreased  1  0/8 (0.00%)  0/7 (0.00%)  0/16 (0.00%)  1/16 (6.25%) 
White blood cell count decreased  1  0/8 (0.00%)  0/7 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
Metabolism and nutrition disorders         
Failure to thrive  1  0/8 (0.00%)  0/7 (0.00%)  1/16 (6.25%)  1/16 (6.25%) 
Hyperkalaemia  1  0/8 (0.00%)  0/7 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
Malnutrition  1  0/8 (0.00%)  0/7 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
Poor feeding infant  1  0/8 (0.00%)  0/7 (0.00%)  0/16 (0.00%)  1/16 (6.25%) 
Underweight  1  3/8 (37.50%)  1/7 (14.29%)  4/16 (25.00%)  0/16 (0.00%) 
Musculoskeletal and connective tissue disorders         
Acquired macrocephaly  1  0/8 (0.00%)  0/7 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
Nervous system disorders         
Hypertonia  1  0/8 (0.00%)  0/7 (0.00%)  0/16 (0.00%)  1/16 (6.25%) 
Hypotonia  1  0/8 (0.00%)  0/7 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
Pregnancy, puerperium and perinatal conditions         
Jaundice neonatal  1  1/8 (12.50%)  0/7 (0.00%)  3/16 (18.75%)  2/16 (12.50%) 
Small for dates baby  1  0/8 (0.00%)  0/7 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
Psychiatric disorders         
Irritability  1  0/8 (0.00%)  0/7 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  0/8 (0.00%)  1/7 (14.29%)  2/16 (12.50%)  4/16 (25.00%) 
Hypoxia  1  0/8 (0.00%)  0/7 (0.00%)  2/16 (12.50%)  0/16 (0.00%) 
Nasal congestion  1  0/8 (0.00%)  3/7 (42.86%)  2/16 (12.50%)  3/16 (18.75%) 
Neonatal hypoxia  1  0/8 (0.00%)  0/7 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
Rhinorrhoea  1  0/8 (0.00%)  0/7 (0.00%)  2/16 (12.50%)  2/16 (12.50%) 
Sneezing  1  0/8 (0.00%)  0/7 (0.00%)  2/16 (12.50%)  0/16 (0.00%) 
Tachypnoea  1  0/8 (0.00%)  0/7 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
Use of accessory respiratory muscles  1  0/8 (0.00%)  0/7 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
Skin and subcutaneous tissue disorders         
Dermatitis diaper  1  1/8 (12.50%)  2/7 (28.57%)  0/16 (0.00%)  2/16 (12.50%) 
Erythema toxicum neonatorum  1  0/8 (0.00%)  0/7 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
Intertrigo  1  0/8 (0.00%)  0/7 (0.00%)  0/16 (0.00%)  1/16 (6.25%) 
Miliaria  1  0/8 (0.00%)  0/7 (0.00%)  0/16 (0.00%)  2/16 (12.50%) 
Papule  1  0/8 (0.00%)  2/7 (28.57%)  0/16 (0.00%)  1/16 (6.25%) 
Petechiae  1  0/8 (0.00%)  0/7 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
Pruritus  1  0/8 (0.00%)  0/7 (0.00%)  0/16 (0.00%)  1/16 (6.25%) 
Rash  1  1/8 (12.50%)  5/7 (71.43%)  1/16 (6.25%)  3/16 (18.75%) 
Rash neonatal  1  0/8 (0.00%)  2/7 (28.57%)  1/16 (6.25%)  3/16 (18.75%) 
Rash papular  1  1/8 (12.50%)  0/7 (0.00%)  0/16 (0.00%)  0/16 (0.00%) 
Seborrhoeic dermatitis  1  0/8 (0.00%)  0/7 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
Vascular disorders         
Haematoma  1  0/8 (0.00%)  0/7 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
1
Term from vocabulary, MedDRA 21.1
Indicates events were collected by systematic assessment
As with other Antiretrovirals (ARVs) in young infants, maraviroc PK parameters showed high intra- and inter-participant variability.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Melissa Allen, Director, IMPAACT Operations Center
Organization: Family Health International (FHI 360)
Phone: (919) 405-1429
EMail: mallen@fhi360.org
Layout table for additonal information
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT02778204    
Other Study ID Numbers: IMPAACT 2007
20734 ( Registry Identifier: DAIDS-ES Registry Number )
First Submitted: May 13, 2016
First Posted: May 19, 2016
Results First Submitted: September 2, 2020
Results First Posted: November 23, 2020
Last Update Posted: November 23, 2020