NCT06834113Recruiting
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
Impact of Two Types of Interventions (Ventrogluteal Versus Dorsogluteal Injection Site; Virtual Reality Headset: Presence or Absence) on Pain After Injections of Vocabria® (Cabotegravir) and Rekambys® (Rilpivirine) in Patients Infected With Human Immunodeficiency Virus -1
Source: ClinicalTrials.gov · Last updated 30 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 31 Jan 2025
- Start date
- 24 Jan 2025
- Primary completion date
- 24 Jul 2026
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Diseases
- HIV
- NCT number
- NCT06834113
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 24 Jan 2025 to the primary completion date, 24 Jul 2026
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient participating in another clinical trial with medication;
Other illness
- Patient(s) with epilepsy;
- 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;
Other
- Patient(s) on another injectable antiretroviral treatment;
- Patient on antidepressant treatment;
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHD Vendée Coordinator of this site? Confirm its status | La Roche-sur-Yon | France | Recruiting |
| CH Chartres Coordinator of this site? Confirm its status | Le Coudray | France | Recruiting |
| CHU Nantes Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| Center Hospitalier Universitaire d'Orléans Coordinator of this site? Confirm its status | Orléans | France | Recruiting |
| CHU Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.