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Search / Trial NCT06834113

Impact of Pain From Injectables Antiretroviral Treatments in HIV-1 Patients Based on the Injection Site (Ventrogluteal or Dorsogluteal) and the Use or Non-use of Virtual Reality Headset

Launched by CENTRE HOSPITALIER RÉGIONAL D'ORLÉANS · Feb 18, 2025

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying how much pain patients with HIV-1 feel from injectable antiretroviral treatments, specifically looking at two different injection sites: the dorsogluteal (the upper outer part of the buttock) and the ventrogluteal (the side of the hip). The trial also examines whether using a virtual reality headset during the injection can help reduce pain. Participants will receive four injections in different sequences, helping researchers understand which method is less painful.

To participate, individuals must be at least 18 years old, have HIV-1 that is under control, and be scheduled to receive injectable treatments with Cabotegravir® and Rilpivirine®. Those currently on other injectable antiretroviral treatments or with certain medical conditions, such as epilepsy or severe motion sickness, won't be eligible. If chosen, participants can expect to try different injection methods and share their pain experiences, helping to improve treatment for others in the future. The study is currently recruiting participants, and all genders are welcome.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patient aged at least 18 years;
  • Patient infected with HIV-1;
  • Patient virologically controlled (VL \< 50 copies/ml);
  • Patient scheduled to receive treatment with cabotegravir and rilpivirine (naïve patients) or currently on injectable cabotegravir and rilpivirine, prescribed by their referring physician.
  • Exclusion Criteria:
  • Patient(s) on another injectable antiretroviral treatment;
  • Patient participating in another clinical trial with medication;
  • Patient(s) with epilepsy;
  • Patient on antidepressant treatment;
  • Patient(s) with psychiatric or behavioral disorders;
  • Patient(s) with a history of dizziness and motion sickness that prevents the use of virtual reality headset;
  • Patient(s) with visual and hearing impairments that prevent the use of virtual reality headset;
  • Patient(s) deprived of liberty, under guardianship or under curatorship;
  • Patient(s) not affiliated with a social security scheme;
  • Pregnant or breastfeeding women.

About Centre Hospitalier Régional D'orléans

The Centre Hospitalier Régional d'Orléans is a leading healthcare institution dedicated to advancing medical research and improving patient care through innovative clinical trials. Located in Orléans, France, the center is committed to fostering a collaborative environment that integrates clinical expertise with cutting-edge research methodologies. By facilitating multidisciplinary studies across various therapeutic areas, the Centre Hospitalier Régional d'Orléans aims to enhance treatment protocols and contribute to the global body of medical knowledge, ultimately benefiting patients and the healthcare community at large.

Locations

Nantes, , France

Le Coudray, , France

Orléans, Loiret, France

Patients applied

0 patients applied

Trial Officials

Daniela PIRES ROTEIA

Principal Investigator

CHU Orléans

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported