A Study to Investigate if Long Acting Cabotegravir (CAB) and Lenacapavir (LEN) Injections Are Tolerable and Acceptable When Administered to Healthy Adults Without HIV

NCT06970223 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: 223616
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the tolerability and acceptability of injection site reactions (ISRs) of two long-acting (LA) injectables. Additional characteristics of the ISRs will be investigated and described as well as safety outcomes.

Conditions

HIV Infections

Keywords

Long-acting; Tolerability; Acceptability; Injection site reactions; Cabotegravir; Lenacapavir; Healthy adults

Outcome Measures

Primary Outcomes (1)

• Percentage of participants reporting very acceptable or totally acceptable local reactions

  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".

  7 days after each injection (injections administered on Day 1 and Day 15)

Secondary Outcomes (14)

• Percentage of participants reporting very acceptable or totally acceptable local reactions at days 43 and 190

  At Day 43 (28 days after second injection) and Day 190 (26 weeks after second injection)

• Mean injection site reaction scores, over time, post-injection, at days 8 and 22

  At Day 8 and Day 22 (7 days after each injection visit)

• Median injection site reaction scores, over time, post-injection, at days 8 and 22

  At Day 8 and Day 22 (7 days after each injection visit)

• Mean injection site reaction scores, over time, post-injection, at days 43 and 190

  At Day 43 (28 days after second injection) and Day 190 (26 weeks after second injection)

• Median injection site reaction scores, over time, post-injection, at days 43 and 190

  At Day 43 (28 days after second injection) and Day 190 (26 weeks after second injection)

Study Arms (2)

CAB LA/LEN LA Group

EXPERIMENTAL

Participants receive the CAB LA injection at Day 1 followed by the LEN LA injections at Day 15.

Drug: Cabotegravir long-acting; Drug: Lenacapavir long-acting

LEN LA/CAB LA Group

EXPERIMENTAL

Participants receive the LEN LA injections at Day 1 followed by the CAB LA injection at Day 15.

Drug: Cabotegravir long-acting; Drug: Lenacapavir long-acting

Interventions

Cabotegravir long-acting DRUG

A single CAB LA injection administered intramuscularly.

Also known as: Cabotegravir

CAB LA/LEN LA Group; LEN LA/CAB LA Group

Lenacapavir long-acting DRUG

Two LEN LA injections administered subcutaneously.

CAB LA/LEN LA Group; LEN LA/CAB LA Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants are eligible to be included in the study only if all the following criteria apply:
• At the time of obtaining informed consent, 18 years of age.
• Body weight 50 kg and BMI within the range 18 to 32 kg/m2 (inclusive).
• Participants who are overtly healthy as determined by medical evaluation by a responsible and experienced physician, including medical history, physical examination, laboratory tests and cardiac monitoring.

You may not qualify if:

• Male or female at birth (transgender individuals are not excluded but LEN may interfere with gender affirming hormones including increasing thrombotic risk. This should be discussed with Medical Monitor).
• All participants are expected to use barrier methods for HIV/STI prevention and should be counselled accordingly at all visits.
• Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• Participants assigned female at birth are eligible to participate if they are not pregnant or breast/chest-feeding, and at least 1 of the following conditions applies:
• Is not a person of childbearing potential (POCBP) OR
• Is a POCBP and using a contraceptive method that is highly effective, with a failure rate of \<1%. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.
• A POCBP must have a negative highly sensitive pregnancy test (urine and/or serum as required) within the 21 days before the dose of study intervention.
• Must be capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
• Participants are excluded from the study if any of the following criteria apply:
• Suspected or known active, serious infection(s).
• Abnormal blood pressure as determined by the investigator.
• History of any malignancy within the past 5 years. Exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy which is considered cured with minimal risk of recurrence. Participants under evaluation for possible malignancy are not eligible.
• Breast cancer within the past 10 years
• Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
• The participant has an underlying skin disease or disorder (i.e., infection, inflammation, dermatitis, eczema, drug rash, drug allergy, psoriasis, food allergy, urticaria) that would interfere with assessment of injection sites.

Sponsors & Collaborators

• ViiV Healthcare: lead

Study Sites (1)

GSK Investigational Site

Long Beach, California, 90815, United States

Location

MeSH Terms

Conditions

HIV Infections; Injection Site Reaction

Interventions

cabotegravir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Extravasation of Diagnostic and Therapeutic Materials; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open-label
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: May 14, 2025
• Study Start: April 22, 2025
• Primary Completion: July 15, 2025
• Study Completion (Estimated): July 10, 2026
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.

Locations

US (1)