Approval Probability
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Cabotegravir long-acting · 1 trial · 1 indication
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...
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Cabotegravir long-acting is an investigational small molecule being studied for the prevention of HIV Infections. It is currently in Phase 1 clinical development as a long-acting injectable formulation. The drug is being evaluated in healthy adults without HIV to assess whether the injections are tolerable and acceptable.
Cabotegravir long-acting is an integrase inhibitor that targets the HIV integrase enzyme, which is essential for viral replication. By blocking this enzyme, the drug prevents the virus from integrating its genetic material into human DNA, thereby inhibiting HIV from multiplying. This mechanism is being studied for its potential in HIV prevention.
Cabotegravir long-acting is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug's safety and tolerability for HIV prevention.
Cabotegravir long-acting is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is assessing the tolerability and acceptability of the long-acting injections in healthy adults without HIV.
Cabotegravir long-acting is being studied in a Phase 1 clinical trial with the identifier NCT06970223. This active, not recruiting study enrolls 65 healthy adults without HIV in the United States. The trial is randomized and controlled, evaluating whether long-acting cabotegravir and lenacapavir injections are tolerable and acceptable.
Cabotegravir long-acting is a formulation of cabotegravir, an integrase inhibitor. The long-acting version is designed for extended-release dosing via injection, whereas other formulations may be taken orally. In the current trial, it is being studied in combination with lenacapavir injections for HIV prevention.