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Noninterventional 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 Germany STR-NIS – (STRike)

Noninterventional 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 Germany STR-NIS – (STRike) - STRike

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00000722
Enrollment
800
Registered
2011-02-25
Start date
2011-03-24
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

B24

Interventions

Group 1: Observational group 1: Atripla use started 12-24 months prior to enrollment Group 2: Observational group 2: Atripla use starting with enrollment, SF 36 questionnaire at Enrollment, and approx

Sponsors

Gilead Sciences GmbH
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: Patients not fulfilling the inclusion criteria.

Design outcomes

Primary

MeasureTime frame
Viral load (HIV RNA) at month 24

Secondary

MeasureTime frame
SF 36 Quality of life (change from Baseline, each visit)

Countries

Germany

Contacts

Public ContactMarion Heinzkill

Gilead Sciences GmbH

marion.heinzkill@gilead.com089 89 98 90 173

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026