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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
CH Chartres
NOT_YET_RECRUITING
Le Coudray
CHU Nantes
NOT_YET_RECRUITING
Nantes
Center Hospitalier Universitaire d'Orléans
RECRUITING
Orléans
Contact Information
Primary
Daniela PIRES ROTEIA
daniela.pires-roteia@chu-orleans.fr
02 38 65 13 38
Backup
Fanny LOUAT
fanny.louat@chu-orleans.fr
02 38 74 42 95
Time Frame
Start Date: 2025-01-24
Estimated Completion Date: 2026-09-24
Participants
Target number of participants: 120
Treatments
Experimental: DCBA (specific order of procedures with type of injection site and/or use virtual reality headset)
A: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset
Experimental: CDBA (specific order of procedures with type of injection site and/or use virtual reality headset)
A: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset
Experimental: DBCA (specific order of procedures with type of injection site and/or use virtual reality headset)
A: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset
Experimental: BDCA (specific order of procedures with type of injection site and/or use virtual reality headset)
A: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset
Experimental: CBDA (specific order of procedures with type of injection site and/or use virtual reality headset)
A: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset
Experimental: BCDA (specific order of procedures with type of injection site and/or use virtual reality headset)
A: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset
Experimental: DCAB (specific order of procedures with type of injection site and/or use virtual reality headset)
A: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset
Experimental: CDAB (specific order of procedures with type of injection site and/or use virtual reality headset)
A: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset
Experimental: DACB (specific order of procedures with type of injection site and/or use virtual reality headset)
A: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset
Experimental: ADCB (specific order of procedures with type of injection site and/or use virtual reality headset)
A: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset
Experimental: CADB (specific order of procedures with type of injection site and/or use virtual reality headset)
A: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset
Experimental: ACDB (specific order of procedures with type of injection site and/or use virtual reality headset)
A: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset
Experimental: DBAC (specific order of procedures with type of injection site and/or use virtual reality headset)
A: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset
Experimental: BDAC (specific order of procedures with type of injection site and/or use virtual reality headset)
A: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset
Experimental: DABC (specific order of procedures with type of injection site and/or use virtual reality headset)
A: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset
Experimental: ADBC (specific order of procedures with type of injection site and/or use virtual reality headset)
A: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset
Experimental: BADC (specific order of procedures with type of injection site and/or use virtual reality headset)
A: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset
Experimental: ABDC (specific order of procedures with type of injection site and/or use virtual reality headset)
A: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset
Experimental: CBAD (specific order of procedures with type of injection site and/or use virtual reality headset)
A: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset
Experimental: BCAD (specific order of procedures with type of injection site and/or use virtual reality headset)
A: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset
Experimental: CABD (specific order of procedures with type of injection site and/or use virtual reality headset)
A: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset
Experimental: ACBD (specific order of procedures with type of injection site and/or use virtual reality headset)
A: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset
Experimental: BACD (specific order of procedures with type of injection site and/or use virtual reality headset)
A: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset
Experimental: ABCD (specific order of procedures with type of injection site and/or use virtual reality headset)
A: dorsogluteal intramuscular injection, B: ventrogluteal intramuscular injection, C: dorsogluteal intramuscular injection with virtual reality headset, D: ventrogluteal intramuscular injection with virtual reality headset
Related Therapeutic Areas
Sponsors
Leads: Centre Hospitalier Régional d'Orléans

This content was sourced from clinicaltrials.gov