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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

Study acronym: VIHINJECT
StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated December 30, 2025 (before its estimated July 24, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Study sites: 3 to 5v4
  2. Re-verified, no change to tracked fieldsv3
  3. Secondary endpoints: 5 to 8v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a multicenter, randomized, open-label study with a cross-over design. The objective of this project is to compare the intensity of pain induced by injectable antiretroviral (ARV) treatment (Cabotegravir® and Rilpivirine®) in patients infected with HIV-1, depending on the injection site and whether or not they are wearing a virtual reality headset. The reference group being the dorsogluteal injection without headset. Participants who meet the study criteria will be randomized into 1 of 24 sequences. A sequence is composed by 4 injections procedures: dorsogluteal intramuscular injection (A), ventrogluteal intramuscular injection (B), dorsogluteal intramuscular injection with virtual reality headset (C), ventrogluteal intramuscular injection with virtual reality headset (D). Each patient will be their own witness and will experience the 4 intramuscular injection procedures of injectable antiretroviral. The study population are patients carrying HIV-1 and being monitored for this pathology, eligible (naïve patients) or already under Cabotegravir® (CAB) and Rilpivirine® (RPV) injectable treatment.
Trial Details
NCT Number NCT06834113
Lead Sponsor Centre Hospitalier Régional d'Orléans
Conditions
(from sponsor)		 HIV I Infection, Injection Pain
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov