At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Dolutegravir Antiretroviral Strategy to Promote Improvement and Reduce Drug Exposure (ASPIRE) Study
In Brief
A Phase 3 clinical trial evaluating dolutegravir, lamivudine, and 1 other intervention for HIV Infection. Completed, enrolled 89 participants across 7 sites.
Detailed Summary
HIV-1 infected subjects with CD4 nadir \> 200 cells/mm3, no history of virologic failure and plasma HIV RNA \<50 copies/mL for at least 48 weeks while on any United States Department of Health and Human Services (DHHS) recommended or alternative three-drug antiretroviral regimen will be randomized to dolutegravir (DTG) plus lamivudine (Arm 1) or continuation of their current regimen (Arm 2) for 48 weeks. The primary endpoint is virologic failure defined as confirmed plasma HIV-1 RNA \> 50 copies/mL before or at Week 24
Study Details
Timeline
Interventions
50 mg tablet by mouth once daily for 48 weeks
300 mg tablet by mouth once daily for 48 weeks
Continue current DHHS recommended or alternative three-drug antiretroviral regimen