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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03945981 | Rapid Test and Treat Dolutegravir Plus Lamivudine Study in Newly Diagnosed Human Immunodeficiency Virus (HIV)-1 Infected Adults | PHASE3 | COMPLETED | 131 | — | — | Jul 2, 2019 | Oct 20, 2020 | Oct 21, 2021 | 16 | United States |
| NCT05674656 | Pharmacokinetics, Safety, Tolerability of Dolutegravir/Rilpivirine in Pediatrics | PHASE1 | RECRUITING | 20 | — | — | Jul 6, 2023 | May 3, 2028 | Sep 19, 2024 | 8 | United States |
Participants were classified as "HIV-1 RNA \<50 c/mL" using an ITT-E missing = Failure analysis. Participants were classified as 'HIV-1 RNA \< 50 c/mL' if the last viral load within the Week 24 visit window was \<50/c/mL, regardless of the ART regimen they were on at the time of viral load assessment (in other words switch from DTG plus 3TC fixed-dose combination \[FDC\] to another ART was not penalized) and as HIV-1 RNA \>= 50 c/mL in all other cases (i.e. last viral load within Week 24 visit window \>= 50 c/mL, on study but having missing viral load data at Week 24, discontinued early from study due to lost to follow-up (LFU), withdrew consent or any other reason). Confidence intervals (CI) were calculated based on the Exact Clopper-Pearson method. Percentage of participants with plasma HIV-1 RNA \< 50 c/mL based on ITT-E missing = Failure analysis at Week 24 are presented.
| Arm | Type | Description |
|---|---|---|
| Participants receiving Dolutegravir + Lamivudine FDC | EXPERIMENTAL | Participants will receive DTG 50mg and 3TC 300 mg FDC tablet orally once daily (OD) with or without food |
| Dolutegravir(DTG)/Rilpivirine (RPV) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Dolutegravir + Lamivudine FDC | DRUG | Dolutegravir + Lamivudine FDC is available as white oval film-coated tablets which are packed in high density polyethylene (HDPE) bottles with induction seals and child-resistant closures. Each 60 milliliter (mL) bottle contains 30 tablets |
| Dolutegravir/Rilpivirine FDC | DRUG | Dolutegravir/Rilpivirine will be administered. |
Inclusion Criteria: * Eligible participants must be able to understand and comply with protocol requirements, instructions, and restrictions. * Eligible participants must be likely to complete the study as planned. * Eligible participants must be considered appropriate candidates for participation ...