Trial Outcomes & Findings for Dolutegravir Study in HIV-1 Participants Completing IMPAACT Studies P1093 and P2019 (NCT NCT03016533)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

100 participants

Primary outcome timeframe

From Day 1 (rollover visit from the parent study) through Year 7 (end of study) or early withdrawal

Results posted on

2026-02-05

Participant Flow

Participants who completed one of the parent studies, either P1093 (NCT01302847) or P2019 (NCT03760458), were enrolled in this rollover study. Participants entered and were evaluated in the study at various study sites beginning June 2017 through December 2024.

Participant milestones

Participant milestones
Measure	Dolutegravir (DTG) Participants that received DTG film-coated tablets or film-coated dispersible tablets in the parent study P1093, at appropriate doses selected as per their age and weight bands.	Abacavir/Dolutegravir/Lamivudine(ABC/DTG/3TC) Participants that received ABC/DTG/3TC immediate release tablets or film-coated dispersible tablets in the parent study P2019, at appropriate doses selected as per their age and weight bands.
Overall Study STARTED	61	39
Overall Study COMPLETED	53	29
Overall Study NOT COMPLETED	8	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Dolutegravir (DTG) Participants that received DTG film-coated tablets or film-coated dispersible tablets in the parent study P1093, at appropriate doses selected as per their age and weight bands.	Abacavir/Dolutegravir/Lamivudine(ABC/DTG/3TC) Participants that received ABC/DTG/3TC immediate release tablets or film-coated dispersible tablets in the parent study P2019, at appropriate doses selected as per their age and weight bands.
Overall Study Protocol Violation	1	0
Overall Study Physician Decision	5	10
Overall Study Withdrawal by Subject	2	0

Baseline Characteristics

Dolutegravir Study in HIV-1 Participants Completing IMPAACT Studies P1093 and P2019

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dolutegravir (DTG) n=61 Participants Participants that received DTG film-coated tablets or film-coated dispersible tablets in the parent study P1093, at appropriate doses selected as per their age and weight bands.	Abacavir/Dolutegravir/Lamivudine(ABC/DTG/3TC) n=39 Participants Participants that received ABC/DTG/3TC immediate release tablets or film-coated dispersible tablets in the parent study P2019, at appropriate doses selected as per their age and weight bands.	Total n=100 Participants Total of all reporting groups
Age, Continuous	7.5 YEARS STANDARD_DEVIATION 4.07 • n=25 Participants	6.7 YEARS STANDARD_DEVIATION 3.14 • n=26 Participants	7.2 YEARS STANDARD_DEVIATION 3.74 • n=51 Participants
Sex: Female, Male Female	32 Participants n=25 Participants	17 Participants n=26 Participants	49 Participants n=51 Participants
Sex: Female, Male Male	29 Participants n=25 Participants	22 Participants n=26 Participants	51 Participants n=51 Participants
Race/Ethnicity, Customized ASIAN	11 Participants n=25 Participants	15 Participants n=26 Participants	26 Participants n=51 Participants
Race/Ethnicity, Customized BLACK OR AFRICAN AMERICAN	47 Participants n=25 Participants	23 Participants n=26 Participants	70 Participants n=51 Participants
Race/Ethnicity, Customized WHITE	3 Participants n=25 Participants	1 Participants n=26 Participants	4 Participants n=51 Participants

PRIMARY outcome

Timeframe: From Day 1 (rollover visit from the parent study) through Year 7 (end of study) or early withdrawal

Population: The analysis was performed on the Safety Set, which included all participants who received at least one dose of study intervention once enrolled in the study. The presented number is representing participants that completed all visits in parent studies.

Outcome measures

Outcome measures
Measure	Dolutegravir (DTG) n=61 Participants Participants that received DTG film-coated tablets or film-coated dispersible tablets in the parent study P1093, at appropriate doses selected as per their age and weight bands.	Abacavir/Dolutegravir/Lamivudine(ABC/DTG/3TC) n=39 Participants Participants that received ABC/DTG/3TC immediate release tablets or film-coated dispersible tablets in the parent study P2019, at appropriate doses selected as per their age and weight bands.
Number of Participants With Continued Access to Age Appropriate Formulation of Dolutegravir	53 Participants	29 Participants

SECONDARY outcome

Timeframe: From Day 1 (rollover visit from the parent study) through Year 7 (end of study) or early withdrawal

Population: The analysis was performed on the Safety Set, which included all participants who received at least one dose of study intervention once enrolled in the study.

An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement. Any = occurrence of the event regardless of intensity grade or relationship to the study interventions.

Outcome measures

Outcome measures
Measure	Dolutegravir (DTG) n=61 Participants Participants that received DTG film-coated tablets or film-coated dispersible tablets in the parent study P1093, at appropriate doses selected as per their age and weight bands.	Abacavir/Dolutegravir/Lamivudine(ABC/DTG/3TC) n=39 Participants Participants that received ABC/DTG/3TC immediate release tablets or film-coated dispersible tablets in the parent study P2019, at appropriate doses selected as per their age and weight bands.
Number of Participants With Any Serious Adverse Events (SAEs)	5 Participants	3 Participants

SECONDARY outcome

Timeframe: From Day 1 (rollover visit from the parent study) through Year 7 (end of study) or early withdrawal

Population: The analysis was performed on the Safety Set .

Outcome measures

Outcome measures
Measure	Dolutegravir (DTG) n=61 Participants Participants that received DTG film-coated tablets or film-coated dispersible tablets in the parent study P1093, at appropriate doses selected as per their age and weight bands.	Abacavir/Dolutegravir/Lamivudine(ABC/DTG/3TC) n=39 Participants Participants that received ABC/DTG/3TC immediate release tablets or film-coated dispersible tablets in the parent study P2019, at appropriate doses selected as per their age and weight bands.
Number of Participants With SAEs Leading to Discontinuation of Study Treatment	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From Day 1 (rollover visit from the parent study) through Year 7 (end of study) or early withdrawal

Population: The analysis was performed on the Safety Set .

Outcome measures

Outcome measures
Measure	Dolutegravir (DTG) n=61 Participants Participants that received DTG film-coated tablets or film-coated dispersible tablets in the parent study P1093, at appropriate doses selected as per their age and weight bands.	Abacavir/Dolutegravir/Lamivudine(ABC/DTG/3TC) n=39 Participants Participants that received ABC/DTG/3TC immediate release tablets or film-coated dispersible tablets in the parent study P2019, at appropriate doses selected as per their age and weight bands.
Number of Participants With Any Clinical or Laboratory Adverse Events (AEs) Leading to Discontinuation of Study Treatment	0 Participants	0 Participants

Adverse Events

Dolutegravir (DTG)

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Abacavir/Dolutegravir/Lamivudine(ABC/DTG/3TC)

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Dolutegravir (DTG) n=61 participants at risk Participants that received DTG film-coated tablets or film-coated dispersible tablets in the parent study P1093, at appropriate doses selected as per their age and weight bands.	Abacavir/Dolutegravir/Lamivudine(ABC/DTG/3TC) n=39 participants at risk Participants that received ABC/DTG/3TC immediate release tablets or film-coated dispersible tablets in the parent study P2019, at appropriate doses selected as per their age and weight bands.
Blood and lymphatic system disorders Anaemia megaloblastic	1.6% 1/61 • Number of events 1 • SAEs and AEs leading to study intervention discontinuation were collected from Day 1 (rollover visit from the parent study) through Year 7 (end of study) or early withdrawal.	0.00% 0/39 • SAEs and AEs leading to study intervention discontinuation were collected from Day 1 (rollover visit from the parent study) through Year 7 (end of study) or early withdrawal.
Gastrointestinal disorders Haemoperitoneum	1.6% 1/61 • Number of events 1 • SAEs and AEs leading to study intervention discontinuation were collected from Day 1 (rollover visit from the parent study) through Year 7 (end of study) or early withdrawal.	0.00% 0/39 • SAEs and AEs leading to study intervention discontinuation were collected from Day 1 (rollover visit from the parent study) through Year 7 (end of study) or early withdrawal.
Infections and infestations COVID-19	1.6% 1/61 • Number of events 1 • SAEs and AEs leading to study intervention discontinuation were collected from Day 1 (rollover visit from the parent study) through Year 7 (end of study) or early withdrawal.	2.6% 1/39 • Number of events 1 • SAEs and AEs leading to study intervention discontinuation were collected from Day 1 (rollover visit from the parent study) through Year 7 (end of study) or early withdrawal.
Infections and infestations Dengue fever	0.00% 0/61 • SAEs and AEs leading to study intervention discontinuation were collected from Day 1 (rollover visit from the parent study) through Year 7 (end of study) or early withdrawal.	2.6% 1/39 • Number of events 1 • SAEs and AEs leading to study intervention discontinuation were collected from Day 1 (rollover visit from the parent study) through Year 7 (end of study) or early withdrawal.
Infections and infestations Epididymitis	1.6% 1/61 • Number of events 1 • SAEs and AEs leading to study intervention discontinuation were collected from Day 1 (rollover visit from the parent study) through Year 7 (end of study) or early withdrawal.	0.00% 0/39 • SAEs and AEs leading to study intervention discontinuation were collected from Day 1 (rollover visit from the parent study) through Year 7 (end of study) or early withdrawal.
Infections and infestations Gastroenteritis	0.00% 0/61 • SAEs and AEs leading to study intervention discontinuation were collected from Day 1 (rollover visit from the parent study) through Year 7 (end of study) or early withdrawal.	2.6% 1/39 • Number of events 1 • SAEs and AEs leading to study intervention discontinuation were collected from Day 1 (rollover visit from the parent study) through Year 7 (end of study) or early withdrawal.
Nervous system disorders Petit mal epilepsy	1.6% 1/61 • Number of events 1 • SAEs and AEs leading to study intervention discontinuation were collected from Day 1 (rollover visit from the parent study) through Year 7 (end of study) or early withdrawal.	0.00% 0/39 • SAEs and AEs leading to study intervention discontinuation were collected from Day 1 (rollover visit from the parent study) through Year 7 (end of study) or early withdrawal.

Other adverse events

Adverse event data not reported

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER