Actively Recruiting
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
Led by Centre Hospitalier Régional d'Orléans · Updated on 2025-12-30
120
Participants Needed
5
Research Sites
86 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient aged at least 18 years
- Patient infected with HIV-1
- Patient virologically controlled (viral load less than 50 copies/ml)
- Patient scheduled to start or currently receiving injectable Cabotegravir and Rilpivirine treatment prescribed by their doctor
You will not qualify if you...
- Patient receiving injectable antiretroviral treatment other than Cabotegravir and Rilpivirine
- Patient participating in another medication clinical trial
- Patient with epilepsy
- Patient on antidepressant treatment
- Patient with psychiatric or behavioral disorders
- Patient with history of dizziness or motion sickness preventing virtual reality headset use
- Patient with visual or hearing impairments preventing virtual reality headset use
- Patient deprived of liberty, or under guardianship or curatorship
- Patient not affiliated with a social security scheme
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 5 locations
1
Center Hospitalier Universitaire d'Orléans
Orléans, Loiret, France, 45067
Actively Recruiting
2
CHD Vendée
La Roche-sur-Yon, France, 85925
Actively Recruiting
3
CH Chartres
Le Coudray, France, 28630
Actively Recruiting
4
CHU Nantes
Nantes, France, 44093
Actively Recruiting
5
CHU Poitiers
Poitiers, France, 90577
Actively Recruiting
Research Team
D
Daniela PIRES ROTEIA
CONTACT
F
Fanny LOUAT
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
PREVENTION
Number of Arms
24
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