Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03016533 | Dolutegravir Study in HIV-1 Participants Completing IMPAACT Studies P1093 and P2019 | PHASE3 | COMPLETED | 100 | — | — | Jun 6, 2017 | Dec 24, 2024 | Feb 5, 2026 | 17 | United States, Botswana +5 |
| Arm | Type | Description |
|---|---|---|
| Dolutegravir (DTG) | EXPERIMENTAL | 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) | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| Dolutegravir film-coated tablets | DRUG | Dolutegravir film-coated tablets will be provided as 50 mg tablets. |
| Dolutegravir film-coated dispersible tablets | DRUG | Dolutegravir film-coated dispersible tablets will be provided as 5 mg dispersible tablets. It will be administered at the appropriate dose as determined by results of the parent protocol to participants as per their age and weight band. |
| ABC/DTG/3TC immediate release tablets | DRUG | ABC/DTG/3TC immediate release tablets will be provided as biconvex, oval tablets containing 600 mg ABC, 50 mg DTG and 300 mg 3TC. |
| ABC/DTG/3TC film-coated dispersible tablets | DRUG | ABC/DTG/3TC dispersible tablets will be provided as biconvex, oval, film-coated tablets containing 60 mg ABC, 5 mg DTG and 30 mg 3TC. |
Inclusion Criteria: * Participant must have completed participation in one of the following parent studies, for the duration noted, with continued benefit from investigational product: 1. P1093 parent study through at least Week 180; 2. P2019 parent study through at least Week 48. * Participan...