Cabotegravir + Lenacapavir for Injection Tolerability

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: ViiV Healthcare

Must not be taking: Glucocorticoids, Immune suppressants

Disqualifiers: Cardiovascular disease, Liver disease, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for healthy adults without HIV. It's designed to test the tolerability and acceptability of long-acting injections aimed at preventing HIV infection. Specific eligibility criteria are not provided, but typically participants must meet certain health standards.

Inclusion Criteria

Participants must be overtly healthy as determined by medical evaluation

Participants with significant clinical abnormalities or laboratory parameters outside the reference range may be included after investigator evaluation

Contraceptive use consistent with local regulations

Exclusion Criteria

Positive Treponeme Specific Serologic testing

ALT greater than or equal to 1.5x ULN

Presence of HBsAg or positive hepatitis C antibody test result

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CAB LA injection at Day 1 and LEN LA injection at Day 15, or vice versa

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

26 weeks

Multiple visits (in-person and virtual)

Treatment Details

Interventions

• Cabotegravir long-acting
• Lenacapavir long-acting

Trial Overview The study is testing two long-acting injectable drugs: Cabotegravir (CAB) and Lenacapavir (LEN). The focus is on how people tolerate the injections and their reactions at the injection site, along with overall safety outcomes.

Participant Groups

Group I: LEN LA/CAB LA Group Experimental Treatment 2 Interventions

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

Group II: CAB LA/LEN LA Group Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

ViiV Healthcare

Lead Sponsor

Trials

379

Recruited

479,000+

Founded

2009

Headquarters

London, England, UK

Known For

HIV Research

Top Products

- Tivicay (dolutegravir), - Triumeq (abacavir/dolutegravir/lamivudine), - Juluca (dolutegravir/rilpivirine), - Apretude (cabotegravir)

Dr. Harmony Garges

ViiV Healthcare

Chief Medical Officer

MD

Deborah Waterhouse

ViiV Healthcare

Chief Executive Officer since 2017

Bachelor's degree in Business Administration