MedTrace Logo

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 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2025-11-28

No results posted yet for this study

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

Interventions

DRUG

Cabotegravir long-acting

A single CAB LA injection administered intramuscularly.

DRUG

Lenacapavir long-acting

Two LEN LA injections administered subcutaneously.

Sponsors & Collaborators

  • ViiV Healthcare

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-22
Primary Completion
2025-07-15
Completion
2026-07-10
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06970223 on ClinicalTrials.gov