| NCT ID | NCT04090151 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rigshospitalet, Denmark |
| Condition | HIV |
| Study Type | OBSERVATIONAL |
| Enrollment | 37,853 participants |
| Start Date | 2017-01-01 |
| Primary Completion | 2025-12 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
The RESPOND Outcomes study is a research study around use of antiretroviral and other relevant drugs and long-term clinical outcomes in patients living with HIV. Data collected in this study will be used to answer key unanswered questions regarding treatment of people living with HIV.
Eligibility Criteria
Inclusion Criteria: 1. Signed Informed consent for the Outcomes study, if required by local/national legislation 2. Signed informed consent for the RESPOND consortium and data repository, if required by local/national legislation 3. Age ≥ 18 years of age 4. Confirmed HIV-1 infection 5. Persons receiving integrase inhibitor (INSTI) based antiretroviral therapy if have started after the later of 1/1/2012 and local cohort enrolment (i.e., during prospective follow-up in the cohort and after 1/1/2012) and have a CD4 and HIV viral load in the 12 months prior to starting INSTI or within 3 months after starting INSTI. 6. ART experienced and ART naïve persons not receiving INSTI if have a CD4 and HIV viral load in the 12 months prior to baseline or within 3 months after baseline (here, the latest of 1/1/2012 or cohort enrolment). 7. Persons lost to follow-up or who died before RESPOND enrolment should therefore still be included in the Outcomes study, provided they satisfy the other inclusion
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