Switch Study to Evaluate Dolutegravir Plus Lamivudine in Virologically Suppressed Human Immunodeficiency Virus Type 1 Positive Adults (TANGO)
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 550
Summary
- Conditions
- HIV Infections
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This is a randomized study with parallel group assignment where subjects will be randomized into one of the two treatment groups. Subjects randomized to DTG + 3TC will receive DTG + 3TC up to Week 200. Subjects randomized to TBR will continue to take their current regimen up to Week 148, at which time and if HIV-1 RNA <50 c/mL at Week 144, these subjects will switch to DTG + 3TC up to Week 200. Randomization will be stratified by Baseline third agent class (protease inhibitor [PI], integrase inhibitor [INI], or non-nucleoside reverse transcriptase inhibitor [NNRTI]).Masking: None (Open Label)Masking Description: This will be an open-label study and therefore no blinding is required. The Sponsor team aims to remain blinded to subject assignment, and will instruct sites to refrain from mentioning assignment when sending in queries (as the sites/subjects will not be blinded). No summaries of the study data according to actual randomized treatment groups will be available to sponsor staff prior to the planned Week 24 preliminary analysis.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Not Provided
Not Provided
Tracking Information
- NCT #
- NCT03446573
- Collaborators
- GlaxoSmithKline
- Investigators
- Study Director: GSK Clinical Trials ViiV Healthcare
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