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Dolutegravir twice daily · 1 trial · 1 indication
Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1) and Day 8. Change from Baseline was calculated as the value at Day 8 minus the value at Baseline (Day 1). The analysis was performed using statistical modeling correcting for Baseline plasma HIV-1 RNA, Baseline Dolutegravir (DTG) fold change (FC), the overall susceptibility score (OSS) of the failing regimen, and the interaction between DTG FC and treatment. Means and differences were calculated using the average Baseline DTG FC of the entire Intent-to-Treat Exposed (ITT-E) Population. The last observation carried forward with discontinuation equals Baseline (LOCFDB) dataset was used for the analysis. For the LOCFDB dataset, missing values were carried forward from the previous, non-missing, available on-treatment assessment, except formissing values due to premature withdrawal or Day 8 missing values, which had the Baseline value imputed.
| Arm | Type | Description |
|---|---|---|
| DTG 50 mg BID | EXPERIMENTAL | Subjects will receive dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all subjects will continue to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase. |
| Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase | EXPERIMENTAL | Subjects will receive matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all subjects will continue to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase. |
| Name | Type | Description |
|---|---|---|
| Dolutegravir 50 mg twice daily | DRUG | Active dolutegravir plus failing background regimen (Day 1 to Day 7). Open label dolutegravir plus optimized background regimen (from Day 8) |
| Dolutegravir placebo twice daily | DRUG | Dolutegravir placebo plus failing background regimen (Day 1 to Day 7) |
Inclusion Criteria: * Screening plasma HIV-1 RNA ≥1000 copies/mL * ART-experienced, INI-experienced, DTG naïve * Current virological failure on raltegravir (RAL) or elvitegravir (ELV) regimen * The subject's HIV-1 shows genotypic resistance to RAL or ELV at Screening * Subject has been on stable AR...
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Dolutegravir twice daily is an investigational small molecule being studied for the treatment of HIV Infections. It is in Phase 3 clinical development and is being evaluated in patients with HIV-1 who have virus resistant to raltegravir and/or elvitegravir. The drug is taken twice daily as part of the treatment regimen.
Dolutegravir twice daily is an integrase inhibitor that targets the HIV integrase enzyme, which is essential for viral replication. By inhibiting this enzyme, the drug prevents the virus from integrating its genetic material into host cells, thereby reducing viral load. This mechanism is particularly relevant for patients with resistance to other integrase inhibitors.
Dolutegravir twice daily is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the safety and efficacy of this drug for the treatment of HIV Infections.
Dolutegravir twice daily is currently in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the results will help determine whether the drug can be submitted for regulatory approval.
Dolutegravir twice daily has been studied in a Phase 3 clinical trial with the identifier NCT01568892. This completed trial, titled 'Study Assessing Dolutegravir in HIV-1 Infected Subjects With Virus Resistant to Raltegravir and/or Elivitegravir,' enrolled 30 participants in the United States. The study was randomized, double-blind, and controlled, with participants aged 18 years and older.
Dolutegravir twice daily is a dosing regimen of the drug dolutegravir, which is an integrase inhibitor used to treat HIV. The twice-daily formulation is being studied specifically for patients with resistance to other integrase inhibitors, such as raltegravir and elvitegravir. This regimen may differ from the standard once-daily dosing of dolutegravir.