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Virus Therapy

Lenacapavir + OBR for Drug-Resistant HIV (CAPELLA Trial)

Q: In how many different geographies is this trial taking place?

With 39 enrolling patients, this study has a broad reach, including locations such as Orlando Immunology Center in Orlando, Floridian Clinical Research in Hialeah, and <a href="https://www.withpower.com/clinical-trials/aids">AIDS</a> Healthcare Foundation - South Beach in Miami Beach.

Q: Are there other instances where Failing ARV Regimen has been looked into?

Currently, there are five ongoing clinical trials studying the effects of Failing ARV Regimen. Three of those trials are in their final Phase 3. Most of the trials for this treatment are taking place in Charleston, <a href="https://www.withpower.com/clinical-trials/south-carolina">South carolina</a>; however, there are 248 total locations running these trials.

Q: What other research exists on this topic?

At this time, there are 5 ongoing clinical trials for Failing ARV Regimen in 81 cities and 14 countries. The first trial began in 2019 and was completed in Phase 2 &#x26; 3. The sponsor of the study was Gilead Sciences and there were 72 patients enrolled. Since 2019, 66 similar trials have been completed.

Q: How many men and women are included in this test?

Unfortunately, this particular trial is not recruiting patients at the moment. The listing was created on November 21st, 2019 but was edited most recently on October 17th, 2020. However, there are other studies that might be of interest; 1290 for patients with infections and 5 for those with Failing ARV Regimen.

Phase 2 & 3

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

Able and willing to receive an OBR together with lenacapavir

Adult aged ≥ 18 years (at all sites) or adolescent aged ≥ 12 and weighing ≥ 35 kg (at sites in North America and Dominican Republic)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to day 1 sc visit (14 days after the first dose of oral lencapavir) or day 15

Awards & highlights

CAPELLA Trial Summary

This trial will test lenacapavir as an addition to existing HIV treatments for people with drug resistance. The goal is to see if lenacapavir can help people with failing HIV treatment regimens.

Who is the study for?

This trial is for adults and adolescents living with HIV who have developed resistance to multiple drugs, specifically at least two agents from three or more of the main classes of antiretroviral (ARV) medications. Participants must be on a failing ARV regimen, have an HIV-1 RNA level ≥ 400 copies/mL, and not have an ongoing Hepatitis C infection.Check my eligibility

What is being tested?

The study tests Lenacapavir's effectiveness when added to a failing drug regimen in patients with multi-drug resistant HIV. It involves comparing placebo treatments against subcutaneous and oral forms of Lenacapavir alongside an Optimized Background Regimen (OBR).See study design

What are the potential side effects?

While specific side effects are not listed here, participants may experience adverse reactions related to Lenacapavir or their individual OBRs. These could include typical ARV-related side effects such as gastrointestinal issues, fatigue, potential liver toxicity, and possible injection site reactions.

CAPELLA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am willing to take lenacapavir with an optimized background regimen.

Select...

I am an adult over 18 or a teenager over 12 and weigh more than 35 kg in North America or the Dominican Republic.

Select...

My HIV treatment is not working against multiple drugs.

Select...

I have only 2 effective HIV drugs left that can be combined.

CAPELLA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to day 1 sc visit (14 days after the first dose of oral lencapavir) or day 15

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to day 1 sc visit (14 days after the first dose of oral lencapavir) or day 15

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to day 1 sc visit (14 days after the first dose of oral lencapavir) or day 15 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 in Cohort 1 Achieving a Reduction of ≥ 0.5 log10 Copies/mL in Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) From Baseline to the End of Functional Monotherapy Period

Secondary outcome measures

Plasma Exchange

Percentage of Participants in Cohort 1 With Plasma HIV-1 RNA < 200 Copies/mL at Week 52 Based on the US FDA-defined Snapshot Algorithm

Percentage of Participants in Cohort 1 With Plasma HIV-1 RNA < 50 Copies/mL at Week 26 Based on the US FDA-defined Snapshot Algorithm

+1 more

CAPELLA Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Cohort 2: LenacapavirExperimental Treatment3 Interventions

Participants with a ≥ 0.5 log10 copies/mL HIV-1 RNA decline at the Cohort Selection Visit compared with the screening visit or with HIV-1 RNA < 400 copies/mL or if Cohort 1 is fully enrolled will receive oral lenacapavir 600 mg tablet on Days 1 and 2 and 300 mg tablet on Day 8, and will initiate an OBR on Day 1 in Oral Lead-in Period (Baseline to Day 14); followed by Maintenance Period where participants will receive SC lenacapavir 927 mg at Day 1 SC Visit (14 days after the first dose of oral lenacapavir) while continuing their OBR. Participants will receive their subsequent SC lenacapavir injection at the Week 26 Visit (relative to Day 1 SC). At Week 52 (relative to Day 1 SC), participants will be given the option to receive SC lenacapavir injections every 6 months (26 weeks), while continuing their OBR, until the product becomes accessible to participants through an access program or until Gilead elects to discontinue the study in the country.

Group II: Cohort 1A: LenacapavirExperimental Treatment4 Interventions

Participants with human-immunodeficiency virus-1 ribonucleic acid (HIV-1 RNA) ≥ 400 copies/mL and with a <0.5 log10 HIV-1 RNA decline at Cohort Selection visit compared with screening visit will receive oral lenacapavir 600 mg tablet on Days 1 and 2 and 300 mg tablet on Day 8, while continuing their failing regimen in blinded Functional Monotherapy Period (Baseline to Day 14); followed by unblinded Maintenance Period where participants will receive subcutaneous (SC) lenacapavir 927 mg and will initiate an OBR at Day 1 SC Visit (14 days after the first dose of oral lenacapavir). Participants will receive their subsequent SC lenacapavir injection at Week 26 Visit (relative to Day 1 SC). At Week 52 (relative to Day 1 SC), participants will be given an option to receive SC lenacapavir injections every 6 months (26 weeks), while continuing their OBR, until product becomes accessible to participants through an access program or until Gilead elects to discontinue the study in the country.

Group III: Cohort 1B: Placebo to LenacapavirPlacebo Group5 Interventions

Participants with HIV-1 RNA ≥ 400 copies/mL and with a <0.5 log10 HIV-1 RNA decline at the Cohort Selection visit compared with screening visit will receive oral lenacapavir placebo on Days 1, 2, and 8 while continuing their failing regimen in blinded Functional Monotherapy Period (Baseline to Day 14); followed by unblinded Maintenance Period where participants will receive oral lenacapavir 600 mg on Days 15 and 16 and 300 mg on Day 22, and will initiate an OBR on Day 15. At Day 1 SC (14 days after the first dose of oral lenacapavir), participants will receive SC lenacapavir 927 mg while continuing OBR. Participants will receive their next SC injection at the Week 26 Visit (relative to Day 1 SC). At Week 52 (relative to Day 1 SC), participants will be given an option to receive SC lenacapavir every 6 months (26 weeks), while continuing their OBR, until the product becomes accessible to participants through an access program or until Gilead elects to discontinue study in the country.

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

Optimized Background Regimen (OBR)

2015

Completed Phase 3

~560

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Gilead SciencesLead Sponsor

1,082 Previous Clinical Trials

842,769 Total Patients Enrolled

Gilead Study DirectorStudy DirectorGilead Sciences

343 Previous Clinical Trials

186,763 Total Patients Enrolled

Media Library

Lenacapavir (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04150068 — Phase 2 & 3

HIV Research Study Groups: Cohort 1A: Lenacapavir, Cohort 2: Lenacapavir, Cohort 1B: Placebo to Lenacapavir

HIV Clinical Trial 2023: Lenacapavir Highlights & Side Effects. Trial Name: NCT04150068 — Phase 2 & 3

Lenacapavir (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04150068 — Phase 2 & 3

Frequently Asked Questions

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

In how many different geographies is this trial taking place?

"With 39 enrolling patients, this study has a broad reach, including locations such as Orlando Immunology Center in Orlando, Floridian Clinical Research in Hialeah, and AIDS Healthcare Foundation - South Beach in Miami Beach."

Answered by AI

Are there other instances where Failing ARV Regimen has been looked into?

"Currently, there are five ongoing clinical trials studying the effects of Failing ARV Regimen. Three of those trials are in their final Phase 3. Most of the trials for this treatment are taking place in Charleston, South carolina; however, there are 248 total locations running these trials."

Answered by AI

What other research exists on this topic?

"At this time, there are 5 ongoing clinical trials for Failing ARV Regimen in 81 cities and 14 countries. The first trial began in 2019 and was completed in Phase 2 & 3. The sponsor of the study was Gilead Sciences and there were 72 patients enrolled. Since 2019, 66 similar trials have been completed."

Answered by AI

How many men and women are included in this test?

"Unfortunately, this particular trial is not recruiting patients at the moment. The listing was created on November 21st, 2019 but was edited most recently on October 17th, 2020. However, there are other studies that might be of interest; 1290 for patients with infections and 5 for those with Failing ARV Regimen."

Answered by AI