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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 used to treat human immunodeficiency virus (HIV) infection. It is a once-daily oral small molecule developed by GSK plc for the infectious disease therapeutic area. The Phase 3 program studied it in ART-naive adults, meaning patients who had not previously received antiretroviral therapy.
Dolutegravir OAD is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor behind the clinical development program for this once-daily dolutegravir formulation in HIV infection.
Dolutegravir OAD is in Phase 3 development. One Phase 3 trial has been completed, and no trials are currently active. The completed study enrolled 488 participants and was randomized and active-controlled, comparing dolutegravir against darunavir/ritonavir, each combined with dual nucleoside reverse transcriptase inhibitors.
Dolutegravir OAD has been studied in the Phase 3 trial NCT01449929, titled "Dolutegravir Compared to Darunavir/Ritonavir, Each in Combination With Dual Nucleoside Reverse Transcriptase Inhibitors (NRTIs) in ART-naive Subjects." The trial is completed, enrolled 488 adults aged 18 and older, and ran across the United States, France, Germany, Italy, Puerto Rico, Romania, Russia, Spain, and Switzerland.