← Back to Search

Antiretroviral Agents

Subcutaneous Lenacapavir for HIV (CALIBRATE Trial)

Phase 2
Waitlist Available
Research Sponsored by Gilead Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0 hours (predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose on day 1
Awards & highlights

CALIBRATE Trial Summary

This trial will study whether lenacapavir can effectively treat HIV in people who already have the virus.

CALIBRATE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0 hours (predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose on day 1
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 hours (predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose on day 1 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants With Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) < 50 Copies/mL at Week 54 as Determined by the United States Food and Drug Administration (US FDA)-Defined Snapshot Algorithm
Secondary outcome measures
Change From Baseline in CD4+ Cell Count at Week 38
Change From Baseline in CD4+ Cell Count at Week 54
Change From Baseline in CD4+ Cell Count at Week 80
+28 more

CALIBRATE Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Lenacapavir, F/TAF, and TAFExperimental Treatment4 Interventions
Induction: Participants will receive oral lenacapavir 600 mg, 600 mg, and 300 mg at Days 1, 2, and 8, respectively. Participants will also begin oral daily emtricitabine/tenofovir alafenamide (F/TAF) 200/25mg from Day 1 onwards for a total of 28 weeks. On Day 15 participants will receive subcutaneous (SC) lenacapavir 927 mg. Maintenance: Participants will receive SC lenacapavir 927 mg at Week 28 and every 26 weeks. Participants will discontinue oral daily F/TAF 200/25 mg at Week 28 and begin taking oral daily TAF 25 mg. May require oral weekly bridging if an SC injection of GS-6207 cannot be administered for any reason within the protocol visit window. Participants willing to continue the study beyond Week 80 will continue to receive SC lenacapavir 927 mg every 6 months (26 weeks) and oral daily TAF 25 mg from Week 80 onwards.
Group II: Lenacapavir, F/TAF, and BICExperimental Treatment4 Interventions
Induction: Participants will receive oral lenacapavir 600 mg, 600 mg, and 300 mg at Days 1, 2, and 8, respectively. Participants will also begin oral daily F/TAF 200/25 mg from Day 1 onward for a total of 28 weeks. On Day 15 participants will receive SC lenacapavir 927 mg. Maintenance: Participants will receive SC lenacapavir 927 mg at Week 28 and every 26 weeks. Participants will discontinue oral daily F/TAF 200/25 mg at Week 28 and begin oral daily bictegravir (BIC) 75 mg. May require oral weekly bridging if an SC injection of GS-6207 cannot be administered for any reason within the protocol visit window. Participants willing to continue the study beyond Week 80 will continue to receive SC lenacapavir 927 mg every 6 months (26 weeks) and oral daily bictegravir (BIC) 75 mg from Week 80 onwards.
Group III: Lenacapavir and F/TAFExperimental Treatment2 Interventions
Participants will receive oral lenacapavir 600 mg at Day 1 and Day 2. On Day 3, participants will begin oral daily lenacapavir 50 mg. Participants will begin oral daily F/TAF 200/25 mg from Day 1 onwards. Participants willing to continue the study beyond Week 80 will continue to receive oral daily lenacapavir 50 mg and oral daily F/TAF 200/25 mg from Week 80 onwards.
Group IV: B/F/TAFActive Control1 Intervention
Participants will receive oral daily bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) 50/200/25 mg at Day 1 and throughout their participation in the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Subcutaneous Lenacapavir
2019
Completed Phase 2
~220
Oral Lenacapavir
2019
Completed Phase 2
~220
BIC
2019
Completed Phase 2
~350
TAF
2015
Completed Phase 3
~2710
F/TAF
2019
Completed Phase 3
~2770

Find a Location

Who is running the clinical trial?

Gilead SciencesLead Sponsor
1,077 Previous Clinical Trials
836,767 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
341 Previous Clinical Trials
185,647 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research require additional participants?

"The trial information found on clinicaltrials.gov indicates that this research is not seeking any fresh participants; the listing, which was initially posted on November 22nd 2019 and last updated April 20th 2022, has been put in pause for now. Luckily, 207 other trials are still recruiting patients at present."

Answered by AI

Has Subcutaneous Lenacapavir been granted approval by the FDA?

"Lenacapavir's safety was assessed at a 2 due to existing Phase Two data which attests to its security but lacks any evidence of it efficacy."

Answered by AI

What conditions is Subcutaneous Lenacapavir most commonly prescribed for?

"Subcutaneous Lenacapavir is the go-to medication for anti-retroviral agents. It has also been known to treat HIV-1 and patients with no resistance to darunavir who have not begun treatment yet."

Answered by AI

How many participants are eligible to partake in this investigation?

"This clinical trial has ceased recruitment, having been initially posted on November 22nd 2019 and the last update dated April 20th 2022. If you are still seeking to participate in a medical study, 107 trials for human immunodeficiency virus type 1 (hiv-1) infection and 100 studies related to Subcutaneous Lenacapavir are currently recruiting patients."

Answered by AI

Are there any earlier clinical experiments that employed Subcutaneous Lenacapavir?

"Lenacapavir was first researched in 2002 at the University of Zurich, with 360 studies completed to date. Currently, there are 100 clinical trials actively underway - a substantial amount based out of Washington D.C.."

Answered by AI

Are there various sites in the city that are currently conducting this clinical trial?

"This clinical trail has recruited 49 medical institutions to participate, such as Whitman-Walker Institute, Inc. in Washington, St. Jude Children's Research Hospital in Memphis and KC CARE Health Center in Kansas City."

Answered by AI
~34 spots leftby Mar 2025