Approval Probability
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Adjusted LOA
ML Risk
dolutegravir OAD · 1 trial · 1 indication
Assessment was done using Missing, Switch or Discontinuation = Failure (MSDF), as codified by the Food and Drug Administration (FDA) "snapshot" algorithm.This algorithm treated all participants without HIV-1 RNA data at Week 48 as nonresponders, as well as participants who switched their concomitant ART prior to Week 48 as follows: background ART substitutions non-permitted per protocol (one background ART substitution was permitted for safety or tolerability); background ART substitutions permitted per protocol unless the decision to switch was documented as being before or at the first on-treatment visit where HIV-1 RNA was assessed. Otherwise, virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment in the snapshot window (Week 48 +/- 6 weeks). Modified Intent-To-Treat Exposed (mITT-E) Population:all randomized participants who received at least one dose of investigational product
| Arm | Type | Description |
|---|---|---|
| dolutegravir 50mg once daily (OAD) | EXPERIMENTAL | in combination with either abacavir/lamivudine fixed dose combination tablet OAD or tenofovir disoproxil fumarate/emtricitabline fixed dose combination tablet OAD |
| darunavir 800mg OAD in combination with ritonavir 100mg OAD | ACTIVE_COMPARATOR | in combination with either abacavir/lamivudine fixed dose combination tablet OAD or tenofovir disoproxil fumarate/emtricitabline fixed dose combination tablet OAD |
| Name | Type | Description |
|---|---|---|
| dolutegravir 50 mg OAD | DRUG | 1 x 50 mg tablet OAD |
| darunavir 800mg OAD | DRUG | 2 x 400mg tablets OAD |
| ritonavir 100mg OAD | DRUG | 1 x 100mg tablet OAD |
Inclusion Criteria: * HIV-1 infected adults greater than or equal to 18 years of age. Females are eligible to enter and participate in the study if she is (1) non-childbearing potential, (2) child bearing potential with negative pregnancy test at screening and Day 1 and agrees to use protocol-speci...
Dolutegravir OAD is an investigational small molecule being studied for the treatment of Human Immunodeficiency Virus (HIV) infection. It is currently in Phase 3 clinical development, meaning it has not yet been approved and remains under investigation for this infectious disease indication.
Dolutegravir OAD is being developed by GSK plc, which trades under the ticker GSK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with HIV infection.
Dolutegravir OAD is in Phase 3 clinical development. It is an investigational drug, not yet approved by regulatory authorities, and is being studied for the treatment of Human Immunodeficiency Virus (HIV) infection.
Dolutegravir OAD has one completed Phase 3 clinical trial, NCT01449929, which enrolled 488 participants. The trial compared dolutegravir to darunavir/ritonavir, each combined with dual nucleoside reverse transcriptase inhibitors (NRTIs), in ART-naive subjects with HIV infection.
Dolutegravir OAD is a formulation of dolutegravir, an integrase inhibitor used in HIV treatment. The OAD designation refers to a once-a-day dosing regimen, distinguishing it from other formulations or dosing schedules of the same active ingredient.