Observational study on long-term outcomes in HIV patients
The RESPOND Outcomes Study - A Study in the RESPOND Consortium (RESPOND: International Cohort Consortium of Infectious Diseases)
Rigshospitalet, Denmark · NCT04090151
This study looks at how well newer HIV treatments work and their safety for patients over time, focusing on different groups of people across Europe, Australia, and South America.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 37853 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark (other) |
| Locations | 18 sites (Sydney, New South Wales and 17 other locations) |
| Trial ID | NCT04090151 on ClinicalTrials.gov |
What this trial studies
The RESPOND Outcomes study focuses on the long-term clinical outcomes of patients living with HIV, particularly examining the use of newer antiretroviral treatments and their safety profiles in routine clinical practice. It aims to monitor the uptake of these treatments and evaluate their effectiveness in various demographic groups. The study involves collaboration among clinics and cohorts across Europe, Australia, and South America, utilizing a common data repository for comprehensive data collection and analysis. This approach allows for a robust examination of treatment patterns and patient outcomes over time.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with confirmed HIV-1 infection who are either starting integrase inhibitor-based antiretroviral therapy or are ART experienced.
Not a fit: Patients who are not living with HIV or those who do not meet the specific inclusion criteria, such as age or treatment history, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness and safety of newer HIV treatments, leading to improved patient care.
How similar studies have performed: Other studies have shown success in evaluating long-term outcomes in HIV treatment, making this approach both relevant and supported by previous findings.
Eligibility criteria
Show full inclusion / exclusion 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 criteria. Exclusion Criteria: 1. Persons receiving INSTI before 1/1/2012 are excluded from the Outcome study 2. Persons aged \< 18 at baseline are excluded from the Outcome study
Where this trial is running
Sydney, New South Wales and 17 other locations
- The Australian HIV Observational Database (AHOD) — Sydney, New South Wales, Australia (RECRUITING)
- Austrian HIV Cohort Study (AHIVCOS), Medizinische Universität Innsbruch — Innsbruck, Austria (RECRUITING)
- CHU Saint-Pierre Hospital — Brussels, Belgium (RECRUITING)
- Rigshospitalet — Copenhagen, Denmark (RECRUITING)
- The EuroSIDA Study, CHIP, Rigshospitalet — Copenhagen, Denmark (RECRUITING)
- Nice HIV Cohort, Centre Hospitalier Universitaire de Nice — Nice, France (RECRUITING)
- Georgian National AIDS Health Information System (AIDS HIS), IDACIRC — Tbilisi, Georgia (RECRUITING)
- University Hospital Bonn — Bonn, Germany (RECRUITING)
- University Hospital Cologne — Cologne, Germany (RECRUITING)
- Frankfurt HIV Cohort Study, Goethe-University Frankfurt — Frankfurt, Germany (RECRUITING)
- Italian Cohort Naive Antiretrovirals (ICONA) — Milano, Italy (RECRUITING)
- San Raffaele Scientific Institute, Ospedale San Raffaele — Milan, Italy (RECRUITING)
- Modena HIV Cohort, Università degli Studi di Modena — Modena, Italy (RECRUITING)
- The ATHENA (AIDS Therapy Evaluation in the Netherlands) national observational HIV cohort, Stichting HIV Monitorin, AMC, University of Amsterdam — Amsterdam, Netherlands (RECRUITING)
- PISCIS Cohort Study, Germans Trias i Pujol University Hospital — Badalona, Spain (RECRUITING)
- Swedish InfCare HIV Cohort, Karolinska University Hospital — Stockholm, Sweden (RECRUITING)
- Swiss HIV Cohort Study (SHCS), University Hospital Zurich — Zurich, Switzerland (RECRUITING)
- Royal Free HIV Cohort Study, Royal Free Hospital — London, United Kingdom (RECRUITING)
Study contacts
- Study coordinator: Lars Peters, MD
- Email: lars.peters@regionh.dk
- Phone: +45 35 45 57 64
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: HIV, Prospective, Cohort, HCV