oninterventional Study of Safety, Efficacy, Adherence, and Health Related Quality of Life in Patients Receiving a Once Daily Single Tablet Regimen for HIV 1 Infection in GermanySTR-NIS – (STRike)
- Conditions
- B24Unspecified human immunodeficiency virus [HIV] disease
- Registration Number
- DRKS00000722
- Lead Sponsor
- Gilead Sciences GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 874
Arm 1 and 2: Adults with HIV-1-infection, who are with their current antiretroviral combination therapy virologically suppressed (HIV-1-RNA < 50 copies/ml) for at least three months.
Arm 3: Antiretroviral naive adults with HIV-1-infection and viral load of <= 100.000 copies HIV-1-RNA/ml
arm 4 - Adults with HIV-1 infection, who are antroretroviral treatment-naïve or are infected with HIV-1 without known mutations associated with resistance to any of the three antiretroviral agents in Stribild
Patients not fulfilling the inclusion criteria.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Viral load (HIV RNA) at month 24
- Secondary Outcome Measures
Name Time Method SF 36 Quality of life (change from Baseline, each visit)