Lenacapavir + OBR for Drug-Resistant HIV
(CAPELLA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called lenacapavir (also known as Sunlenca) for individuals with drug-resistant HIV. The goal is to evaluate lenacapavir's effectiveness when added to an ineffective treatment plan. The study includes different groups: some will start with lenacapavir, while others will initially receive a placebo before switching to the actual drug. Individuals with HIV who are on a treatment plan that isn't working well and have limited other treatment options might be suitable for this trial. As a Phase 2, Phase 3 trial, this study assesses lenacapavir's effectiveness in a smaller group and represents the final step before FDA approval, offering participants a chance to contribute to groundbreaking research.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop your current medications, but it mentions that participants should be on a stable failing regimen for more than 8 weeks. This suggests you may continue your current medications while adding lenacapavir.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that lenacapavir is generally well-tolerated by people with HIV. When combined with other carefully chosen HIV medications, lenacapavir effectively controlled the virus over two years, and participants managed the treatment well. Studies found no major safety issues. This suggests lenacapavir could be a safe option for those with drug-resistant HIV, though individual experiences may differ.12345
Why do researchers think this study treatment might be promising for HIV?
Lenacapavir is unique because it targets HIV differently than most current treatments. While typical HIV therapies focus on inhibiting viral enzymes like reverse transcriptase or protease, Lenacapavir is a capsid inhibitor, which means it disrupts the HIV virus's protective shell. This novel mechanism can potentially overcome drug resistance issues seen with other treatments. Additionally, Lenacapavir offers a convenient dosing schedule, with the option of subcutaneous injections every six months, reducing the pill burden for patients. Researchers are excited about its potential to enhance treatment for those with drug-resistant HIV, providing a new avenue for managing the condition.
What evidence suggests that lenacapavir could be an effective treatment for drug-resistant HIV?
Research has shown that lenacapavir effectively treats HIV that doesn't respond to other drugs. In this trial, participants in Cohort 1A and Cohort 2 will receive lenacapavir, while those in Cohort 1B will initially receive a placebo before switching to lenacapavir. One study found that 88% of people taking lenacapavir experienced a significant drop in their HIV levels after just 14 days, compared to only 17% of those taking a placebo. Over a longer period, when combined with other HIV treatments, lenacapavir kept the virus under control for up to 104 weeks. This suggests lenacapavir could be a strong option for people with HIV resistant to multiple drugs.12678
Who Is on the Research Team?
Gilead Study Director
Principal Investigator
Gilead Sciences
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Functional Monotherapy Period
Participants receive oral lenacapavir or placebo while continuing their failing regimen
Maintenance Period
Participants receive subcutaneous lenacapavir and initiate an optimized background regimen
Optional Extension
Participants may opt to continue receiving subcutaneous lenacapavir at Weeks 52 and 156
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Lenacapavir
Trial Overview
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).
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
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 LEN 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 LEN 927 mg at Day 1 SC Visit (14 days after the first dose of oral LEN) while continuing their OBR. Participants will receive their subsequent SC LEN injection at Week 26 Visit (relative to Day 1 SC). Participants will be given an option to receive SC LEN injection at Weeks 52 and 156, 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.
Participants with HIV-1 ribonucleic acid (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 (LEN) 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) LEN 927 mg and will initiate an optimized background regimen (OBR) at Day 1 SC Visit (14 days after the first dose of oral LEN). Participants will receive their subsequent SC LEN injection at Week 26 Visit (relative to Day 1 SC). Participants will be given an option to receive SC LEN injection at Weeks 52 and 156, 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.
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 LEN 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 LEN 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 LEN), participants will receive SC LEN 927 mg while continuing OBR. Participants will receive their subsequent SC LEN injection at Week 26 Visit (relative to Day 1 SC). Participants will be given an option to receive SC LEN injection at Weeks 52 and 156, 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.
Lenacapavir is already approved in United States for the following indications:
- Treatment of HIV
Find a Clinic Near You
Who Is Running the Clinical Trial?
Gilead Sciences
Lead Sponsor
Daniel O'Day
Gilead Sciences
Chief Executive Officer since 2019
MBA from Columbia University
Dietmar Berger
Gilead Sciences
Chief Medical Officer
MD and PhD from Albert-Ludwigs University School of Medicine
Published Research Related to This Trial
Citations
SUNLENCA® (lenacapavir) Efficacy Data | HCP Site
88% of participants taking SUNLENCA achieved a ≥0.5 log 10 copies/mL reduction in HIV-1 RNA after 14 days vs 17% of participants taking placebo.
Week 104 Results of a Phase 2/3 Trial
Treatment with subcutaneous lenacapavir in combination with an OBR was well tolerated and resulted in a high rate of virological suppression over 104 weeks.
Lenacapavir for multidrug-resistant HIV-1 infection - PMC
Lenacapavir plus an optimised background antiretroviral regimen may be useful for patients with multidrug-resistant HIV-1 infection with inadequate viral ...
Gilead Presents New Data on Twice Yearly Lenacapavir ...
New Data from PURPOSE Trials Further Demonstrate that Lenacapavir (Yeztugo®) was Effective and Well Tolerated Across a Broad Range of ...
Clinical Recommendation for the Use of Injectable ...
This report describes a clinical recommendation to use injectable lenacapavir as an HIV preexposure prophylaxis.
NCT04150068 | Study to Evaluate the Safety and Efficacy ...
Efficacy and safety of the novel capsid inhibitor lenacapavir to treat multidrug-resistant HIV: week 52 results of a phase 2/3 trial. Lancet HIV. 2023 Aug ...
Efficacy and Safety of Long-Acting Subcutaneous Lenacapavir ...
In a In a Phase 2/3 study, treatment with lenacapavir, a long-acting HIV-1 capsid inhibitor, plus an optimized background regimen, was well tolerated, with.
Gilead Presents New HIV Research Data at EACS 2025
The accumulated data suggests that lenacapavir, like other moderate CYP3A4 inhibitors, can be co-administered with statins and PDE5 inhibitors ...
Other People Viewed
By Subject
By Trial
Related Searches
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.