Condition: HIV I Infection · Injection Pain · Sponsor: Centre Hospitalier Régional d'Orléans
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.
This description comes directly from the study's public registry record.
Daniela PIRES ROTEIA · 02 38 65 13 38 · daniela.pires-roteia@chu-orleans.fr
Fanny LOUAT · 02 38 74 42 95 · fanny.louat@chu-orleans.fr
Always discuss trial participation with your own doctor first.
| Center Hospitalier Universitaire d'Orléans | Orléans, Loiret, France | Recruiting |
| CHD Vendée | La Roche-sur-Yon, France | Recruiting |
| CH Chartres | Le Coudray, France | Recruiting |
| CHU Nantes | Nantes, France | Recruiting |
| CHU Poitiers | Poitiers, France | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06834113