Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06970223 | A Study to Investigate if Long Acting Cabotegravir (CAB) and Lenacapavir (LEN) Injections Are Tolerable and Acceptable When Administered to Healthy Adults Without HIV | PHASE1 | ACTIVE NOT_RECRUITING | 65 | — | — | Apr 22, 2025 | Jul 10, 2026 | Nov 28, 2025 | 1 | United States |
The analysis is performed using the 21-item perception of injection (PIN) questionnaire which includes 21 items grouped into 4 multi-item domains: 'Acceptance of ISR' scale score (2 items); 'Bother from ISR' scale score (6 items); 'Leg movement' scale score (4 items); 'Sleep' scale score (4 items); and 5 standalone items: pain during injection; anxiety before injection; anxiety after injection; willingness to be injected in the future; and overall satisfaction with mode of administration. Participant responses are scored on a 5-point Likert scale, where 1 represents the least favorable perception of injection and 5 the most favorable, with domain scores calculated as the mean of all items in that domain. "Acceptance of ISR" is reported in this outcome measure for 2 scores: "very acceptable ISR: and "totally acceptable ISR".
| Arm | Type | Description |
|---|---|---|
| CAB LA/LEN LA Group | EXPERIMENTAL | Participants receive the CAB LA injection at Day 1 followed by the LEN LA injections at Day 15. |
| LEN LA/CAB LA Group | EXPERIMENTAL | Participants receive the LEN LA injections at Day 1 followed by the CAB LA injection at Day 15. |
| Name | Type | Description |
|---|---|---|
| Cabotegravir long-acting | DRUG | A single CAB LA injection administered intramuscularly. |
| Lenacapavir long-acting | DRUG | Two LEN LA injections administered subcutaneously. |
Inclusion Criteria: Participants are eligible to be included in the study only if all the following criteria apply: 1. At the time of obtaining informed consent, 18 years of age. 2. Body weight 50 kg and BMI within the range 18 to 32 kg/m2 (inclusive). 3. Participants who are overtly healthy as de...