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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01568892 | Study Assessing Dolutegravir in HIV-1 Infected Subjects With Virus Resistant to Raltegravir and/or Elivitegravir | PHASE3 | COMPLETED | 30 | — | — | Apr 18, 2012 | Dec 16, 2013 | Jul 2, 2018 | 25 | United States |
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...