Safety of and Immune Response to Dolutegravir in HIV-1 Infected Infants, Children, and Adolescents
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01302847 |
Recruitment Status :
Active, not recruiting
First Posted : February 24, 2011
Results First Posted : March 22, 2022
Last Update Posted : March 22, 2022
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Study Type | Interventional |
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Study Design | Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
HIV Infections |
Interventions |
Drug: DTG film-coated tablets Drug: DTG granules for suspension Drug: DTG dispersible tablets |
Enrollment | 181 |
Recruitment Details | Participants were enrolled from April 20, 2011 to February 19, 2020. Participants were recruited from 9 countries in North America, South America, Africa, and Asia. |
Pre-assignment Details | There was no study randomization. A participant was enrolled to a cohort based on their age at study entry. |
Arm/Group Title | Cohort I | Cohort IIA | Cohort III | Cohort IIB | Cohort IV | Cohort III-DT | Cohort IV-DT | Cohort V-DT |
---|---|---|---|---|---|---|---|---|
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Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets. DTG film-coated tablets initial starting dose at ~1 mg/kg with a maximum dose of 50 mg; orally once daily. |
Children 6 to younger than 12 years of age who received DTG film-coated tablets. DTG film-coated tablets initial starting dose at ~1 mg/kg with a maximum dose of 50 mg; orally once daily. |
Children 2 to younger than 6 years of age who received DTG granules for suspension. DTG granules for suspension initial starting dose at ~0.64 mg/kg with a maximum dose of 32 mg; orally once daily. |
Children 6 to younger than 12 years of age who received DTG granules for suspension. DTG granules for suspension initial starting dose at ~0.64 mg/kg with a maximum dose of 32 mg; orally once daily. |
Children 6 months to younger than 2 years of age who received DTG granules for suspension. DTG granules for suspension initial starting dose at ~0.64 mg/kg with a maximum dose of 32 mg; orally once daily. |
Children 2 to younger than 6 years of age who received DTG dispersible tablets. DTG dispersible tablets initial starting dose of ~0.8 mg/kg with a maximum dose of 30 mg; orally once daily. |
Children 6 months to younger than 2 years of age who received DTG dispersible tablets. DTG dispersible tablets initial starting dose of ~1.25 mg/kg with a maximum dose of 30 mg; orally once daily. |
Infants 4 weeks to younger than 6 months of age who received DTG dispersible tablets. DTG dispersible tablets initial starting dose of ~1.25 mg/kg with a maximum dose of 30 mg; orally once daily. |
Period Title: Overall Study | ||||||||
Started | 23 | 23 | 17 | 15 | 7 | 36 | 35 | 25 |
Completed [1] | 10 | 16 | 15 | 14 | 5 | 6 | 9 | 3 |
Not Completed | 13 | 7 | 2 | 1 | 2 | 30 | 26 | 22 |
Reason Not Completed | ||||||||
Ongoing | 0 | 0 | 0 | 0 | 0 | 27 | 22 | 17 |
Death | 0 | 1 | 0 | 0 | 0 | 1 | 1 | 0 |
Pregnancy | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Virologic failure | 0 | 2 | 2 | 0 | 1 | 1 | 0 | 2 |
Severe debilitation, unable to continue | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 |
Not able to get to clinic | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
Site closing | 2 | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
Withdrawal by Subject | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 1 |
Not willing to adhere to requirements | 5 | 0 | 0 | 1 | 0 | 0 | 0 | 2 |
Site unable to contact participant | 2 | 1 | 0 | 0 | 0 | 0 | 2 | 0 |
[1]
Study is ongoing. Some participants are still in follow-up. Participant Flow Overview will be updated upon study completion. Summary tables are based on data through database freeze date (March 24, 2021) for this primary results submission.
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Arm/Group Title | Cohort I | Cohort IIA | Cohort IIB | Cohort III | Cohort IV | Cohort III-DT | Cohort IV-DT | Cohort V-DT | Total | |
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Adolescents 12 to younger than 18 years of age who received DTG film-coated tablets. DTG film-coated tablets initial starting dose at ~1 mg/kg with a maximum dose of 50 mg; orally once daily. |
Children 6 to younger than 12 years of age who received DTG film-coated tablets. DTG film-coated tablets initial starting dose at ~1 mg/kg with a maximum dose of 50 mg; orally once daily. |
Children 6 to younger than 12 years of age who received DTG granules for suspension. DTG granules for suspension initial starting dose at ~0.64 mg/kg with a maximum dose of 32 mg; orally once daily. |
Children 2 to younger than 6 years of age who received DTG granules for suspension. DTG granules for suspension initial starting dose at ~0.64 mg/kg with a maximum dose of 32 mg; orally once daily. |
Children 6 months to younger than 2 years of age who received DTG granules for suspension. DDTG granules for suspension initial starting dose at ~0.64 mg/kg with a maximum dose of 32 mg; orally once daily. |
Children 2 to younger than 6 years of age who received DTG dispersible tablets. DTG dispersible tablets initial starting dose of ~0.8 mg/kg with a maximum dose of 30 mg; orally once daily. |
Children 6 months to younger than 2 years of age who received DTG dispersible tablets. DTG dispersible tablets initial starting dose of ~1.25 mg/kg with a maximum dose of 30 mg; orally once daily. |
Infants 4 weeks to younger than 6 months of age who received DTG dispersible tablets. DTG dispersible tablets initial starting dose of ~1.25 mg/kg with a maximum dose of 30 mg; orally once daily. |
Total of all reporting groups | |
Overall Number of Baseline Participants | 23 | 23 | 15 | 17 | 7 | 36 | 35 | 25 | 181 | |
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Participants who received at least one dose of DTG.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
||||||||||
Number Analyzed | 23 participants | 23 participants | 15 participants | 17 participants | 7 participants | 36 participants | 35 participants | 25 participants | 181 participants | |
14.26 (1.79) | 8.96 (1.99) | 7.73 (1.79) | 3.59 (1.00) | 1.14 (0.41) | 3.25 (1.18) | 1.13 (0.44) | 0.03 (0.01) | 4.84 (4.78) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||||||||
Number Analyzed | 23 participants | 23 participants | 15 participants | 17 participants | 7 participants | 36 participants | 35 participants | 25 participants | 181 participants | |
Female |
18 78.3%
|
7 30.4%
|
3 20.0%
|
8 47.1%
|
5 71.4%
|
13 36.1%
|
20 57.1%
|
12 48.0%
|
86 47.5%
|
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Male |
5 21.7%
|
16 69.6%
|
12 80.0%
|
9 52.9%
|
2 28.6%
|
23 63.9%
|
15 42.9%
|
13 52.0%
|
95 52.5%
|
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
||||||||||
Number Analyzed | 23 participants | 23 participants | 15 participants | 17 participants | 7 participants | 36 participants | 35 participants | 25 participants | 181 participants | |
Hispanic or Latino |
6 26.1%
|
6 26.1%
|
4 26.7%
|
8 47.1%
|
1 14.3%
|
6 16.7%
|
4 11.4%
|
2 8.0%
|
37 20.4%
|
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Not Hispanic or Latino |
16 69.6%
|
13 56.5%
|
6 40.0%
|
6 35.3%
|
6 85.7%
|
28 77.8%
|
31 88.6%
|
23 92.0%
|
129 71.3%
|
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Unknown or Not Reported |
1 4.3%
|
4 17.4%
|
5 33.3%
|
3 17.6%
|
0 0.0%
|
2 5.6%
|
0 0.0%
|
0 0.0%
|
15 8.3%
|
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 23 participants | 23 participants | 15 participants | 17 participants | 7 participants | 36 participants | 35 participants | 25 participants | 181 participants | |
American Indian or Alaska Native |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Asian |
3 13.0%
|
3 13.0%
|
3 20.0%
|
2 11.8%
|
3 42.9%
|
7 19.4%
|
1 2.9%
|
3 12.0%
|
25 13.8%
|
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Native Hawaiian or Other Pacific Islander |
0 0.0%
|
1 4.3%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
1 0.6%
|
|
Black or African American |
12 52.2%
|
12 52.2%
|
10 66.7%
|
11 64.7%
|
3 42.9%
|
25 69.4%
|
30 85.7%
|
20 80.0%
|
123 68.0%
|
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White |
7 30.4%
|
3 13.0%
|
0 0.0%
|
2 11.8%
|
0 0.0%
|
1 2.8%
|
2 5.7%
|
0 0.0%
|
15 8.3%
|
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More than one race |
0 0.0%
|
1 4.3%
|
0 0.0%
|
1 5.9%
|
0 0.0%
|
3 8.3%
|
2 5.7%
|
2 8.0%
|
9 5.0%
|
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Unknown or Not Reported |
1 4.3%
|
3 13.0%
|
2 13.3%
|
1 5.9%
|
1 14.3%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
8 4.4%
|
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Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
||||||||||
United States | Number Analyzed | 23 participants | 23 participants | 15 participants | 17 participants | 7 participants | 36 participants | 35 participants | 25 participants | 181 participants |
20 87.0%
|
16 69.6%
|
5 33.3%
|
5 29.4%
|
0 0.0%
|
3 8.3%
|
2 5.7%
|
0 0.0%
|
51 28.2%
|
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Botswana | Number Analyzed | 23 participants | 23 participants | 15 participants | 17 participants | 7 participants | 36 participants | 35 participants | 25 participants | 181 participants |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
1 14.3%
|
1 2.8%
|
1 2.9%
|
2 8.0%
|
5 2.8%
|
||
Tanzania | Number Analyzed | 23 participants | 23 participants | 15 participants | 17 participants | 7 participants | 36 participants | 35 participants | 25 participants | 181 participants |
0 0.0%
|
0 0.0%
|
0 0.0%
|
1 5.9%
|
0 0.0%
|
3 8.3%
|
3 8.6%
|
3 12.0%
|
10 5.5%
|
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Brazil | Number Analyzed | 23 participants | 23 participants | 15 participants | 17 participants | 7 participants | 36 participants | 35 participants | 25 participants | 181 participants |
0 0.0%
|
0 0.0%
|
2 13.3%
|
5 29.4%
|
1 14.3%
|
6 16.7%
|
2 5.7%
|
3 12.0%
|
19 10.5%
|
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South Africa | Number Analyzed | 23 participants | 23 participants | 15 participants | 17 participants | 7 participants | 36 participants | 35 participants | 25 participants | 181 participants |
0 0.0%
|
4 17.4%
|
6 40.0%
|
4 23.5%
|
2 28.6%
|
6 16.7%
|
4 11.4%
|
2 8.0%
|
28 15.5%
|
||
Uganda | Number Analyzed | 23 participants | 23 participants | 15 participants | 17 participants | 7 participants | 36 participants | 35 participants | 25 participants | 181 participants |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
2 5.7%
|
1 4.0%
|
3 1.7%
|
||
Zimbabwe | Number Analyzed | 23 participants | 23 participants | 15 participants | 17 participants | 7 participants | 36 participants | 35 participants | 25 participants | 181 participants |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
3 8.3%
|
15 42.9%
|
10 40.0%
|
28 15.5%
|
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Kenya | Number Analyzed | 23 participants | 23 participants | 15 participants | 17 participants | 7 participants | 36 participants | 35 participants | 25 participants | 181 participants |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
8 22.2%
|
5 14.3%
|
1 4.0%
|
14 7.7%
|
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Thailand | Number Analyzed | 23 participants | 23 participants | 15 participants | 17 participants | 7 participants | 36 participants | 35 participants | 25 participants | 181 participants |
3 13.0%
|
3 13.0%
|
2 13.3%
|
2 11.8%
|
3 42.9%
|
6 16.7%
|
1 2.9%
|
3 12.0%
|
23 12.7%
|
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Weight
Mean (Standard Deviation) Unit of measure: Kg |
||||||||||
Number Analyzed | 23 participants | 23 participants | 15 participants | 17 participants | 7 participants | 36 participants | 35 participants | 25 participants | 181 participants | |
55.1 (15.6) | 30.1 (10.4) | 23.0 (4.6) | 14.4 (2.9) | 8.4 (2.0) | 13.7 (2.6) | 8.5 (1.8) | 5.7 (1.1) | 19.6 (17.0) | ||
Height
Mean (Standard Deviation) Unit of measure: Cm |
||||||||||
Number Analyzed | 23 participants | 23 participants | 15 participants | 17 participants | 7 participants | 36 participants | 35 participants | 25 participants | 181 participants | |
155.4 (8.9) | 131.1 (14.0) | 121.2 (9.6) | 95.9 (8.7) | 71.0 (6.0) | 93.4 (8.9) | 71.9 (5.7) | 59.2 (3.7) | 98.9 (32.4) | ||
CD4 Cell Count
[1] Median (Inter-Quartile Range) Unit of measure: Cells/mm^3 |
||||||||||
Number Analyzed | 23 participants | 23 participants | 15 participants | 17 participants | 6 participants | 36 participants | 35 participants | 25 participants | 180 participants | |
466.0
(297 to 771)
|
645.0
(466 to 732)
|
749.0
(306 to 1041)
|
900.0
(565 to 1399)
|
1482.5
(1190 to 1827)
|
1049.5
(559.5 to 1883)
|
2121.0
(1422 to 2384)
|
1916.0
(1357 to 2680)
|
1053.0
(618 to 1914.5)
|
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[1]
Measure Analysis Population Description: Participants who had non-missing values were summarized. One participant in Cohort IV had missing value.
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CD4 Percent
[1] Median (Inter-Quartile Range) Unit of measure: Percentage of total lymphocytes |
||||||||||
Number Analyzed | 23 participants | 23 participants | 15 participants | 17 participants | 6 participants | 36 participants | 35 participants | 25 participants | 180 participants | |
22.0
(18.4 to 29.2)
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24.0
(14.3 to 28.7)
|
25.3
(20 to 33)
|
25.0
(20 to 31)
|
20.7
(14.6 to 31.1)
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24.0
(17.2 to 31.1)
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24.2
(19.8 to 32.2)
|
22.7
(20.6 to 30.4)
|
24.0
(18.3 to 31)
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[1]
Measure Analysis Population Description: Participants who had non-missing values were summarized. One participant in Cohort IV had missing value.
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CD8 Cell Count
[1] Median (Inter-Quartile Range) Unit of measure: Cells/mm^3 |
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Number Analyzed | 23 participants | 23 participants | 15 participants | 17 participants | 6 participants | 36 participants | 35 participants | 25 participants | 180 participants | |
1009.0
(788 to 1303)
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1089.0
(955 to 1774)
|
1103.0
(948 to 1757)
|
1730.0
(1148 to 1991)
|
1888.5
(1441 to 2796)
|
1725.0
(1258 to 2561.5)
|
2922.0
(2050 to 4546)
|
2435.0
(1468 to 3789)
|
1679.0
(1074.5 to 2725)
|
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[1]
Measure Analysis Population Description: Participants who had non-missing values were summarized. One participant in Cohort IV had missing value.
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CD8 Percent
[1] Median (Inter-Quartile Range) Unit of measure: Percentage of total lymphocytes |
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Number Analyzed | 23 participants | 23 participants | 15 participants | 17 participants | 6 participants | 36 participants | 35 participants | 25 participants | 180 participants | |
49.5
(43.8 to 59)
|
53.0
(43 to 58.6)
|
48.0
(44 to 51)
|
39.7
(35.1 to 49.3)
|
28.5
(18.2 to 34.4)
|
42.2
(29.5 to 50.2)
|
39.4
(31.3 to 47.2)
|
31.6
(24 to 41.8)
|
43.0
(32 to 50.8)
|
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[1]
Measure Analysis Population Description: Participants who had non-missing values were summarized. One participant in Cohort IV had missing value.
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Baseline Plasma HIV-1 RNA (copies/mL)
Measure Type: Count of Participants Unit of measure: Participants |
||||||||||
Number Analyzed | 23 participants | 23 participants | 15 participants | 17 participants | 7 participants | 36 participants | 35 participants | 25 participants | 181 participants | |
<400 |
0 0.0%
|
0 0.0%
|
1 6.7%
|
0 0.0%
|
1 14.3%
|
2 5.6%
|
1 2.9%
|
1 4.0%
|
6 3.3%
|
|
400 - <1,000 |
0 0.0%
|
1 4.3%
|
0 0.0%
|
0 0.0%
|
1 14.3%
|
3 8.3%
|
1 2.9%
|
0 0.0%
|
6 3.3%
|
|
1,000 - <5,000 |
2 8.7%
|
3 13.0%
|
1 6.7%
|
2 11.8%
|
0 0.0%
|
5 13.9%
|
7 20.0%
|
7 28.0%
|
27 14.9%
|
|
5,000 - <10,000 |
4 17.4%
|
1 4.3%
|
1 6.7%
|
1 5.9%
|
0 0.0%
|
1 2.8%
|
4 11.4%
|
3 12.0%
|
15 8.3%
|
|
10,000 - <25,000 |
8 34.8%
|
0 0.0%
|
3 20.0%
|
0 0.0%
|
0 0.0%
|
4 11.1%
|
4 11.4%
|
2 8.0%
|
21 11.6%
|
|
25,000 - <50,000 |
5 21.7%
|
4 17.4%
|
1 6.7%
|
2 11.8%
|
1 14.3%
|
5 13.9%
|
3 8.6%
|
1 4.0%
|
22 12.2%
|
|
50,000 - <100,000 |
2 8.7%
|
3 13.0%
|
6 40.0%
|
5 29.4%
|
1 14.3%
|
4 11.1%
|
1 2.9%
|
0 0.0%
|
22 12.2%
|
|
>=100,000 |
2 8.7%
|
11 47.8%
|
2 13.3%
|
7 41.2%
|
3 42.9%
|
12 33.3%
|
14 40.0%
|
11 44.0%
|
62 34.3%
|
|
HIV-1 log10 RNA
Mean (Standard Deviation) Unit of measure: Log10 copies/mL |
||||||||||
Number Analyzed | 23 participants | 23 participants | 15 participants | 17 participants | 7 participants | 36 participants | 35 participants | 25 participants | 181 participants | |
4.3 (0.5) | 4.9 (1.0) | 4.4 (0.8) | 4.9 (0.9) | 4.5 (1.4) | 4.5 (1.2) | 4.6 (1.1) | 4.6 (1.4) | 4.6 (1.1) | ||
Class of Prior Antiretroviral Therapy (ART)
[1] Measure Type: Count of Participants Unit of measure: Participants |
||||||||||
Nucleoside reverse transcriptase inhibitor (NRTI) | Number Analyzed | 23 participants | 23 participants | 15 participants | 17 participants | 7 participants | 36 participants | 35 participants | 25 participants | 181 participants |
23 100.0%
|
23 100.0%
|
14 93.3%
|
17 100.0%
|
6 85.7%
|
30 83.3%
|
29 82.9%
|
23 92.0%
|
165 91.2%
|
||
Non-nucleoside reverse transcriptase inhibitor (NNRTI) | Number Analyzed | 23 participants | 23 participants | 15 participants | 17 participants | 7 participants | 36 participants | 35 participants | 25 participants | 181 participants |
12 52.2%
|
13 56.5%
|
10 66.7%
|
5 29.4%
|
5 71.4%
|
14 38.9%
|
18 51.4%
|
15 60.0%
|
92 50.8%
|
||
Protease inhibitor (PI) | Number Analyzed | 23 participants | 23 participants | 15 participants | 17 participants | 7 participants | 36 participants | 35 participants | 25 participants | 181 participants |
18 78.3%
|
17 73.9%
|
10 66.7%
|
15 88.2%
|
5 71.4%
|
25 69.4%
|
28 80.0%
|
20 80.0%
|
138 76.2%
|
||
Fusion inhibitor (FI) | Number Analyzed | 23 participants | 23 participants | 15 participants | 17 participants | 7 participants | 36 participants | 35 participants | 25 participants | 181 participants |
2 8.7%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
2 1.1%
|
||
[1]
Measure Description: Note: These categories are not mutually exclusive since some participants would have received multiple ARTs.
|