CClinicalTrials.gg
Sign In
Active, not recruitingNCT04150068CAPELLAUpdated Oct 1, 2026Results posted

Study to Evaluate the Safety and Efficacy of Lenacapavir (GS-6207) in Combination With an Optimized Background Regimen (OBR) in Heavily Treatment Experienced Participants Living With HIV-1 Infection With Multidrug Resistance

A Phase 2/3 interventional study of Oral Lenacapavir and Oral Lenacapavir Placebo in HIV-1-infection, sponsored by Gilead Sciences. Active, not recruiting at 75 sites in 11 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-10-01.

Sponsored by Gilead Sciences · Phase 2/3, Interventional, and Treatment

Updated Oct 1, 2026Study completion movedGo to Updates ↓
Phase
Phase 2/3
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
12 Years and older
Sex
All
01

Study summary

The primary objective of this study is to evaluate the antiviral activity of lenacapavir (formerly GS-6207) administered as an add-on to a failing regimen for 14 days (functional monotherapy) in people with human immunodeficiency virus type 1 (HIV-1) (PWH) with multi-drug resistance (MDR).

02

Conditions studied

  • HIV-1-infection
03

In context

Lead sponsor

Gilead Sciences is the lead sponsor of 680 studies on the registry; 24 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 249 (96%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  • Adult aged ≥ 18 years (at all sites) or adolescent aged ≥ 12 and weighing ≥ 35 kg (at sites in North America and Dominican Republic)
  • Currently receiving a stable failing ARV regimen for > 8 weeks
  • Have HIV-1 RNA ≥ 400 copies/mL at screening
  • Have multidrug resistance (resistance to ≥2 agents from ≥3 of the 4 main classes of ARV)
  • Have no more than 2 fully active ARV remaining from the 4 main classes that can be effectively combined to form a viable regimen
  • Able and willing to receive an OBR together with lenacapavir
  • No Hepatitis C virus (HCV) ongoing infection

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
72 participants (actual)

Study arms

  • Experimental
    Cohort 1A: Lenacapavir

    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 the 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). 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 the product becomes accessible to participants through an access program or until Gilead elects to discontinue the study in the country.

    Drug: Oral Lenacapavir · Drug: Subcutaneous Lenacapavir · Drug: Failing ARV Regimen · Drug: Optimized Background Regimen (OBR)

  • Placebo comparator
    Cohort 1B: Placebo to Lenacapavir

    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 the 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. 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 the product becomes accessible to participants through an access program or until Gilead elects to discontinue the study in the country.

    Drug: Oral Lenacapavir · Drug: Oral Lenacapavir Placebo · Drug: Subcutaneous Lenacapavir · Drug: Failing ARV Regimen · Drug: Optimized Background Regimen (OBR)

  • Experimental
    Cohort 2: Lenacapavir

    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. 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 the product becomes accessible to participants through an access program or until Gilead elects to discontinue the study in the country.

    Drug: Oral Lenacapavir · Drug: Subcutaneous Lenacapavir · Drug: Optimized Background Regimen (OBR)

Interventions

  • DrugOral Lenacapavir

    Tablets administered without regard to food

    Also known as: Sunlenca®, GS-6207

  • DrugOral Lenacapavir Placebo

    Tablets administered without regard to food

  • DrugSubcutaneous Lenacapavir

    Administered in the abdomen via subcutaneous injections

    Also known as: Sunlenca®, GS-6207

  • DrugFailing ARV Regimen

    Failing antiretroviral (ARV) regimen defined by the lack of efficacy. Any combination of approved and unapproved agents that could potentially be part of the failing regimen.

  • DrugOptimized Background Regimen (OBR)

    Optimized background regimen as prescribed by the Investigator

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline up to Day 1 SC Visit (14 days after the first dose of oral lencapavir) or Day 15

Secondary outcomes

  1. 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

    The percentage of participants in cohort 1 with plasma HIV-1 RNA \< 50 copies/mL at Week 26 was analyzed using the United States Food and Drug Administration (US FDA)-defined snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

    Time frame: Week 26 (26 weeks after first dose of subcutaneous lenacapavir)

  2. Percentage of Participants in Cohort 1 With Plasma HIV-1 RNA < 200 Copies/mL at Week 26 Based on the US FDA-defined Snapshot Algorithm

    The percentage of participants in cohort 1 with plasma HIV-1 RNA \< 200 copies/mL at Week 26 was analyzed using the US FDA-defined snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

    Time frame: Week 26 (26 weeks after first dose of subcutaneous lenacapavir)

  3. Percentage of Participants in Cohort 1 With Plasma HIV-1 RNA < 50 Copies/mL at Week 52 Based on the US FDA-defined Snapshot Algorithm

    The percentage of participants in cohort 1 with plasma HIV-1 RNA \< 50 copies/mL at Week 52 was analyzed using the US FDA-defined snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Percentages were rounded off.

    Time frame: Week 52 (52 weeks after first dose of subcutaneous lenacapavir)

  4. 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

    The percentage of participants in cohort 1 with plasma HIV-1 RNA \< 200 copies/mL at Week 52 was analyzed using the US FDA-defined snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Percentages were rounded off.

    Time frame: Week 52 (52 weeks after first dose of subcutaneous lenacapavir)

  5. Percentage of Participants in Combined Cohorts 1 and 2 With Plasma HIV-1 RNA < 50 Copies/mL at Week 104 Based on the US FDA-defined Snapshot Algorithm

    The percentage of participants in combined cohorts 1 and 2 with plasma HIV-1 RNA \< 50 copies/mL at Week 104 was analyzed using the US FDA-defined snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Percentages were rounded off.

    Time frame: Week 104 (104 weeks after first dose of subcutaneous lenacapavir)

  6. Percentage of Participants in Combined Cohorts 1 and 2 With Plasma HIV-1 RNA < 200 Copies/mL at Week 104 Based on the US FDA-defined Snapshot Algorithm

    The percentage of participants in combined cohorts 1 and 2 with plasma HIV-1 RNA \< 200 copies/mL at Week 104 was analyzed using the US FDA-defined snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Percentages were rounded off.

    Time frame: Week 104 (104 weeks after first dose of subcutaneous lenacapavir)

  7. Percentage of Participants in Combined Cohorts 1 and 2 With Plasma HIV-1 RNA < 50 Copies/mL at Week 156 Based on the US FDA-defined Snapshot Algorithm

    The percentage of participants in combined cohorts 1 and 2 with plasma HIV-1 RNA \< 50 copies/mL at Week 156 was analyzed using the US FDA-defined snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Percentages were rounded off.

    Time frame: Week 156 (156 weeks after first dose of subcutaneous lenacapavir)

  8. Percentage of Participants in Combined Cohorts 1 and 2 With Plasma HIV-1 RNA < 200 Copies/mL at Week 156 Based on the US FDA-defined Snapshot Algorithm

    The percentage of participants in combined cohorts 1 and 2 with plasma HIV-1 RNA \< 200 copies/mL at Week 156 was analyzed using the US FDA-defined snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Percentages were rounded off.

    Time frame: Week 156 (156 weeks after first dose of subcutaneous lenacapavir)

07

Results

Posted Oct 20, 2021

Participant flow

Participants were enrolled at study sites in the United States, Thailand, Italy, Dominican Republic, Spain, France, Canada, Taiwan, South Africa, Japan, and Germany.

Functional Mono/Oral Lead-in (14 Days)
Participant flow — Functional Mono/Oral Lead-in (14 Days)
MilestoneCohort 1A: LenacapavirCohort 1B: Placebo to LenacapavirCohort 2: Lenacapavir
Started241236
Completed241236
Not completed000
Maintenance Period (Week 52 Analysis)
Participant flow — Maintenance Period (Week 52 Analysis)
MilestoneCohort 1A: LenacapavirCohort 1B: Placebo to LenacapavirCohort 2: Lenacapavir
Started241236
Completed231132
Not completed114
Withdrew: Death001
Withdrew: Investigator's discretion001
Withdrew: Lost to follow-up102
Withdrew: Completed the maintenance period and did not enter the extension period010
Extension Period (Week 156 Analysis)
Participant flow — Extension Period (Week 156 Analysis)
MilestoneCohort 1A: LenacapavirCohort 1B: Placebo to LenacapavirCohort 2: Lenacapavir
Started231132
Completed19515
Not completed4617
Withdrew: Still on study239
Withdrew: Adverse event101
Withdrew: Death002
Withdrew: Investigator's discretion010
Withdrew: Withdrew consent104
Withdrew: Lost to follow-up021

Outcome measures

PrimaryPercentage 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
Time frame:
Baseline up to Day 1 SC Visit (14 days after the first dose of oral lencapavir) or Day 15
Reported as:
Number · percentage of participants
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
percentage of participantsCohort 1A: LenacapavirCohort 1B: Placebo to Lenacapavir
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 Period87.516.7
Statistical analysis
  • Cohort 1A: Lenacapavir vs Cohort 1B: Placebo to Lenacapavir · Chan & Zhang method · p = < 0.0001 (The P value and 95% confidence interval (CI) for the point estimate of treatment difference in proportions was estimated and constructed using the Chan and Zhang method.) · Percentage difference: 70.8 · 95% CI 34.9 to 90.0
SecondaryPercentage of Participants in Cohort 1 With Plasma HIV-1 RNA < 50 Copies/mL at Week 26 Based on the US FDA-defined Snapshot Algorithm

The percentage of participants in cohort 1 with plasma HIV-1 RNA \< 50 copies/mL at Week 26 was analyzed using the United States Food and Drug Administration (US FDA)-defined snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

Time frame:
Week 26 (26 weeks after first dose of subcutaneous lenacapavir)
Reported as:
Number · percentage of participants
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
percentage of participantsCohort 1A: LenacapavirCohort 1B: Placebo to Lenacapavir
Percentage of Participants in Cohort 1 With Plasma HIV-1 RNA < 50 Copies/mL at Week 26 Based on the US FDA-defined Snapshot Algorithm87.5 (67.6 to 97.3)66.7 (34.9 to 90.1)
SecondaryPercentage of Participants in Cohort 1 With Plasma HIV-1 RNA < 200 Copies/mL at Week 26 Based on the US FDA-defined Snapshot Algorithm

The percentage of participants in cohort 1 with plasma HIV-1 RNA \< 200 copies/mL at Week 26 was analyzed using the US FDA-defined snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

Time frame:
Week 26 (26 weeks after first dose of subcutaneous lenacapavir)
Reported as:
Number · percentage of participants
Percentage of Participants in Cohort 1 With Plasma HIV-1 RNA < 200 Copies/mL at Week 26 Based on the US FDA-defined Snapshot Algorithm
percentage of participantsCohort 1A: LenacapavirCohort 1B: Placebo to Lenacapavir
Percentage of Participants in Cohort 1 With Plasma HIV-1 RNA < 200 Copies/mL at Week 26 Based on the US FDA-defined Snapshot Algorithm95.8 (78.9 to 99.9)75.0 (42.8 to 94.5)
SecondaryPercentage of Participants in Cohort 1 With Plasma HIV-1 RNA < 50 Copies/mL at Week 52 Based on the US FDA-defined Snapshot Algorithm

The percentage of participants in cohort 1 with plasma HIV-1 RNA \< 50 copies/mL at Week 52 was analyzed using the US FDA-defined snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Percentages were rounded off.

Time frame:
Week 52 (52 weeks after first dose of subcutaneous lenacapavir)
Reported as:
Number · percentage of participants
Percentage of Participants in Cohort 1 With Plasma HIV-1 RNA < 50 Copies/mL at Week 52 Based on the US FDA-defined Snapshot Algorithm
percentage of participantsCohort 1A: LenacapavirCohort 1B: Placebo to Lenacapavir
Percentage of Participants in Cohort 1 With Plasma HIV-1 RNA < 50 Copies/mL at Week 52 Based on the US FDA-defined Snapshot Algorithm87.5 (67.6 to 97.3)75.0 (42.8 to 94.5)
SecondaryPercentage of Participants in Cohort 1 With Plasma HIV-1 RNA < 200 Copies/mL at Week 52 Based on the US FDA-defined Snapshot Algorithm

The percentage of participants in cohort 1 with plasma HIV-1 RNA \< 200 copies/mL at Week 52 was analyzed using the US FDA-defined snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Percentages were rounded off.

Time frame:
Week 52 (52 weeks after first dose of subcutaneous lenacapavir)
Reported as:
Number · percentage of participants
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 participantsCohort 1A: LenacapavirCohort 1B: Placebo to Lenacapavir
Percentage of Participants in Cohort 1 With Plasma HIV-1 RNA < 200 Copies/mL at Week 52 Based on the US FDA-defined Snapshot Algorithm91.7 (73.0 to 99.0)75.0 (42.8 to 94.5)
SecondaryPercentage of Participants in Combined Cohorts 1 and 2 With Plasma HIV-1 RNA < 50 Copies/mL at Week 104 Based on the US FDA-defined Snapshot Algorithm

The percentage of participants in combined cohorts 1 and 2 with plasma HIV-1 RNA \< 50 copies/mL at Week 104 was analyzed using the US FDA-defined snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Percentages were rounded off.

Time frame:
Week 104 (104 weeks after first dose of subcutaneous lenacapavir)
Reported as:
Number · percentage of participants
Percentage of Participants in Combined Cohorts 1 and 2 With Plasma HIV-1 RNA < 50 Copies/mL at Week 104 Based on the US FDA-defined Snapshot Algorithm
percentage of participantsCombined Cohorts 1 (Cohort 1A and Cohort 1B): Lenacapavir or Placebo to LenacapavirCohort 2: Lenacapavir
Percentage of Participants in Combined Cohorts 1 and 2 With Plasma HIV-1 RNA < 50 Copies/mL at Week 104 Based on the US FDA-defined Snapshot Algorithm68.6 (50.7 to 83.1)55.6 (38.1 to 72.1)
SecondaryPercentage of Participants in Combined Cohorts 1 and 2 With Plasma HIV-1 RNA < 200 Copies/mL at Week 104 Based on the US FDA-defined Snapshot Algorithm

The percentage of participants in combined cohorts 1 and 2 with plasma HIV-1 RNA \< 200 copies/mL at Week 104 was analyzed using the US FDA-defined snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Percentages were rounded off.

Time frame:
Week 104 (104 weeks after first dose of subcutaneous lenacapavir)
Reported as:
Number · percentage of participants
Percentage of Participants in Combined Cohorts 1 and 2 With Plasma HIV-1 RNA < 200 Copies/mL at Week 104 Based on the US FDA-defined Snapshot Algorithm
percentage of participantsCombined Cohorts 1 (Cohort 1A and Cohort 1B): Lenacapavir or Placebo to LenacapavirCohort 2: Lenacapavir
Percentage of Participants in Combined Cohorts 1 and 2 With Plasma HIV-1 RNA < 200 Copies/mL at Week 104 Based on the US FDA-defined Snapshot Algorithm68.6 (50.7 to 83.1)58.3 (40.8 to 74.5)
SecondaryPercentage of Participants in Combined Cohorts 1 and 2 With Plasma HIV-1 RNA < 50 Copies/mL at Week 156 Based on the US FDA-defined Snapshot Algorithm

The percentage of participants in combined cohorts 1 and 2 with plasma HIV-1 RNA \< 50 copies/mL at Week 156 was analyzed using the US FDA-defined snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Percentages were rounded off.

Time frame:
Week 156 (156 weeks after first dose of subcutaneous lenacapavir)
Reported as:
Number · percentage of participants
Percentage of Participants in Combined Cohorts 1 and 2 With Plasma HIV-1 RNA < 50 Copies/mL at Week 156 Based on the US FDA-defined Snapshot Algorithm
percentage of participantsCombined Cohorts 1 (Cohort 1A and Cohort 1B): Lenacapavir or Placebo to LenacapavirCohort 2: Lenacapavir
Percentage of Participants in Combined Cohorts 1 and 2 With Plasma HIV-1 RNA < 50 Copies/mL at Week 156 Based on the US FDA-defined Snapshot Algorithm64.7 (46.5 to 80.3)58.3 (40.8 to 74.5)
SecondaryPercentage of Participants in Combined Cohorts 1 and 2 With Plasma HIV-1 RNA < 200 Copies/mL at Week 156 Based on the US FDA-defined Snapshot Algorithm

The percentage of participants in combined cohorts 1 and 2 with plasma HIV-1 RNA \< 200 copies/mL at Week 156 was analyzed using the US FDA-defined snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Percentages were rounded off.

Time frame:
Week 156 (156 weeks after first dose of subcutaneous lenacapavir)
Reported as:
Number · percentage of participants
Percentage of Participants in Combined Cohorts 1 and 2 With Plasma HIV-1 RNA < 200 Copies/mL at Week 156 Based on the US FDA-defined Snapshot Algorithm
percentage of participantsCombined Cohorts 1 (Cohort 1A and Cohort 1B): Lenacapavir or Placebo to LenacapavirCohort 2: Lenacapavir
Percentage of Participants in Combined Cohorts 1 and 2 With Plasma HIV-1 RNA < 200 Copies/mL at Week 156 Based on the US FDA-defined Snapshot Algorithm67.6 (49.5 to 82.6)58.3 (40.8 to 74.5)

Adverse events

Collected over All-Cause Mortality and Adverse Events: Up to Week 156 (156 weeks after first dose of subcutaneous lenacapavir). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Cohort 1A: Lenacapavir0/24 (0%)7/24 (29.2%)23/24 (95.8%)
Cohort 1B: Placebo to Lenacapavir0/12 (0%)4/12 (33.3%)12/12 (100%)
Cohort 2: Lenacapavir3/36 (8.3%)11/36 (30.6%)35/36 (97.2%)
Most frequent serious events
Showing 10 of 40
Most frequent serious events
EventCohort 1A: LenacapavirCohort 1B: Placebo to LenacapavirCohort 2: Lenacapavir
PneumoniaInfections and infestations1/242/121/36
Angina pectorisCardiac disorders1/241/120/36
Angina unstableCardiac disorders0/241/120/36
Abdominal painGastrointestinal disorders0/241/120/36
Pancreatic massGastrointestinal disorders0/241/120/36
Clostridium difficile colitisInfections and infestations0/241/120/36
Covid-19Infections and infestations1/241/120/36
Dengue feverInfections and infestations0/241/120/36
DehydrationMetabolism and nutrition disorders0/240/122/36
ProctalgiaGastrointestinal disorders1/240/120/36
Most frequent other events
Showing 10 of 176
Most frequent other events
EventCohort 1A: LenacapavirCohort 1B: Placebo to LenacapavirCohort 2: Lenacapavir
Injection site noduleGeneral disorders13/245/1210/36
Injection site swellingGeneral disorders10/245/1219/36
Injection site painGeneral disorders11/244/1213/36
Injection site erythemaGeneral disorders8/242/1216/36
NauseaGastrointestinal disorders7/242/125/36
Covid-19Infections and infestations7/242/128/36
DiarrhoeaGastrointestinal disorders5/243/127/36
Injection site indurationGeneral disorders2/240/129/36
Weight decreasedInvestigations1/243/122/36
HyperglycaemiaMetabolism and nutrition disorders0/243/121/36

Baseline characteristics

Safety Analysis Set included participants who were enrolled and received at least 1 dose of study drug.

Age, Continuous
Age, Continuous(years)Cohort 1A: LenacapavirCohort 1B: Placebo to LenacapavirCohort 2: LenacapavirTotal
Mean54 ± 11.349 ± 10.948 ± 13.750 ± 12.6
Sex: Female, Male
Sex: Female, Male(Participants)Cohort 1A: LenacapavirCohort 1B: Placebo to LenacapavirCohort 2: LenacapavirTotal
Female73818
Male1792854
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Cohort 1A: LenacapavirCohort 1B: Placebo to LenacapavirCohort 2: LenacapavirTotal
Race — Asian211215
Race — Black1061127
Race — White1241329
Race — Not Permitted0101
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Cohort 1A: LenacapavirCohort 1B: Placebo to LenacapavirCohort 2: LenacapavirTotal
Ethnicity — Hispanic or Latino64515
Ethnicity — Not Hispanic or Latino1873156
Ethnicity — Not Permitted0101
Region of Enrollment
Region of Enrollment(Participants)Cohort 1A: LenacapavirCohort 1B: Placebo to LenacapavirCohort 2: LenacapavirTotal
Canada0022
Dominican Republic0101
France0123
Italy1067
South Africa0011
Spain1001
Taiwan0011
Thailand21811
United States2091342
Japan0022
Germany0011
HIV-1 RNA (log10 copies/mL)
HIV-1 RNA (log10 copies/mL)(log10 copies/mL)Cohort 1A: LenacapavirCohort 1B: Placebo to LenacapavirCohort 2: LenacapavirTotal
Mean3.97 ± 0.9224.87 ± 0.3934.06 ± 1.1644.17 ± 1.034
HIV-1 RNA Categories
HIV-1 RNA Categories(Participants)Cohort 1A: LenacapavirCohort 1B: Placebo to LenacapavirCohort 2: LenacapavirTotal
≤ 100000 copies/mL2362958
> 100000 copies/mL16714
08

Study locations

75 sites
  • Ruane Clinical Research Group Inc
    Los Angeles, California 90036, United States
  • Mills Clinical Research
    Los Angeles, California 90069, United States
  • Eisenhower Health Center at Rimrock
    Palm Springs, California 92264, United States
  • One Community Health
    Sacramento, California 95817, United States
  • Yale University; School of Medicine
    New Haven, Connecticut 06510, United States
  • Washington Health Institute
    Washington D.C., District of Columbia 20017, United States
  • Midland Florida Clinical Research Center, LLC
    DeLand, Florida 32720, United States
  • Gary J. Richmond, M.D., P.A.
    Fort Lauderdale, Florida 33316, United States
  • Midway Immunology and Research Center
    Ft. Pierce, Florida 34982, United States
  • Floridian Clinical Research
    Hialeah, Florida 33016, United States
  • AIDS Healthcare Foundation - South Beach
    Miami Beach, Florida 33139, United States
  • Orlando Immunology Center
    Orlando, Florida 32803, United States
  • St. Joseph's Hospital Comprehensive Research Institute
    Tampa, Florida 33614, United States
  • Triple O Research Institute, P.A.
    West Palm Beach, Florida 33401, United States
  • Emory Hospital Midtown Infectious Disease Clinic
    Atlanta, Georgia 30308, United States
  • Atlanta ID Group, PC
    Atlanta, Georgia 30309, United States
  • Chatham County Health Department
    Savannah, Georgia 31401, United States
  • Howard Brown Health Center
    Chicago, Illinois 60613, United States
  • Northstar Healthcare
    Chicago, Illinois 60657, United States
  • Be Well Medical Center
    Berkley, Michigan 48072, United States
  • Southampton Healthcare, Inc.
    St Louis, Missouri 63139, United States
  • New York-Presbyterian/Queens
    Flushing, New York 11355, United States
  • North Shore University Hospital/Division of Infectious Diseases
    Manhasset, New York 11030, United States
  • Jacobi Medical Center
    The Bronx, New York 10461, United States
  • Atrium Health- Infectious Disease Consultants
    Charlotte, North Carolina 28209, United States
  • Perelman Center for Advanced Medicine at the Hospital of the University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
  • The Miriam Hospital
    Providence, Rhode Island 02906, United States
  • 1265 Union Avenue, 8 East
    Memphis, Tennessee 38163, United States
  • Central Texas Clinical Research
    Austin, Texas 78705, United States
  • St Hope Foundation
    Bellaire, Texas 77401, United States
  • AIDS Arms, Inc. DBA Prism Health North Texas
    Dallas, Texas 75215, United States
  • North Texas Infectious Diseases Consultants, P.A.
    Dallas, Texas 75246, United States
  • The Crofoot Research Center, INC.
    Houston, Texas 77098, United States
  • DCOL Center for Clinical Research
    Longview, Texas 75605, United States
  • Clinical Alliance for Research and Education - Infectious Diseases, LLC (CARE-ID)
    Annandale, Virginia 22003, United States
  • Vancouver ID Research and Care Centre Society
    Vancouver, British Columbia V6Z 2C9, Canada
  • Maple Leaf Research/Maple Leaf Medical Clinic
    Toronto, Ontario M5G 1K2, Canada
  • Clinique de médecine urbaine du Quartier Latin
    Montreal, Quebec H2L 4E9, Canada
  • The Ottawa Hospital
    Ottawa, K1H 8L6, Canada
  • Instituto Dominicano de Estudios Virologicos (IDEV)
    Santo Domingo, 10103, Dominican Republic
  • Hospital Dr. Salvador Bienvenido Gautier
    Santo Domingo, 10514, Dominican Republic
  • Hôpital Sainte-Marguerite
    Marseille, 13009, France
  • Hôpital Saint-Louis
    Paris, 75010, France
  • Hôpital Saint-Antoine
    Paris, 75012, France
  • Hôpital Bichat-Claude Bernard
    Paris, 75018, France
  • Universitätsklinikum Frankfurt, Medizinische Klinik II
    Frankfurt am Main, Hesse 60590, Germany
  • Universitätsklinikum Essen, Klinik für Dermatologie und Venerologie
    Essen, 45122, Germany
  • ICH Study Center GmbH & Co. KG
    Hamburg, 20146, Germany
  • University of Naples Federico II
    Bergamo, 24127, Italy
  • UOC Malattie Infettive - ASST Spedali Civili Di Brescia - Piazzale Spedali Civili 1
    Brescia, 25100, Italy
  • Divisione di Malattie Infettive, IRCCS Ospedale San Raffaele
    Milan, 20127, Italy
  • U.O.C. IMMUNODEFICIENZE VIRALI - Istituto Nazionale Malattie Infettive Lazzaro Spallanzani IRCCS
    Roma, 00149, Italy
  • U.O.C. Malattie Infettive - Fondazione Policlinico Universitario A. Gemelli IRCCS
    Rome, 00168, Italy
  • National Hospital Organization Nagoya Medical Center
    Nagoya, 460-0001, Japan
  • National Hospital Organization Osaka National Hospital
    Osaka, 540-0006, Japan
  • Tokyo Medical University Hospital
    Tokyo, 1600023, Japan
  • Center Hospital of the National Center for Global Health and Medicine
    Tokyo, 1628655, Japan
  • Durban International Clinical Research Site, Enhancing Care Foundation
    Durban, 4302, South Africa
  • Helen Joseph Hospital
    Johannesburg, 2092, South Africa
  • Vx Pharma
    Pretoria, 87, South Africa
  • Perinatal HIV Research Unit (PHRU)
    Soweto, 2013, South Africa
  • Hospital Universitari Germans Trías i Pujol
    Badalona, 08916, Spain
  • Hospital Clinic de Barcelona
    Barcelona, 08036, Spain
  • Hospital Universitario La Paz
    Madrid, 28046, Spain
  • Hospital Universitario Virgen del Rocío
    Seville, 41013, Spain
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
    Kaohsiung City, 80756, Taiwan
  • Kaohsiung Veterans General Hospital
    Kaohsiung City, 81362, Taiwan
  • Far Eastern Memorial Hospital
    New Taipei City, 22060, Taiwan
  • National Taiwan University Hospital
    Taipei, 10048, Taiwan
  • Taoyuan General Hospital, Ministry of Health and Welfare
    Taoyuan City, 33004, Taiwan
  • Thai Red Cross AIDS Research Center
    Bangkok, 10330, Thailand
  • Faculty of Medicine Ramathibodi Hospital, Mahidol University
    Bangkok, 10400, Thailand
  • Faculty of Medicine Siriraj Hospital, Mahidol University
    Bangkok, 10700, Thailand
  • Faculty of Medicine, Khon Kaen University
    Khon Kaen, 40002, Thailand
  • Bamrasnaradura Infectious Diseases Institute
    Nonthaburi, 11000, Thailand
09

References and documents

Publications

  • Segal-Maurer S, Castagna A, Berhe M, et al. Potent Antiviral Activity of Lenacapavir in Phase 2/3 in Heavily ART-Experienced PWH [Abstract 127]. Presented at: Conference on Retroviruses and Opportunistic Infections; 2021 March 6-10.
  • Ogbuagu O, Ratanasuwan W, Avihingsanon A, Chetchotisakd P, Wiznia A, Kimberly W, et al. Lenacapavir Efficacy in CAPELLA Patients with No Fully Active Agents in Optimized Background Regimen. Presented at: Conference on Retroviruses and Opportunistic Infections (CROI), 2024 March 3-6
  • Margot N, Pennetzdorfer N, Naik V, Rhee M, Callebaut C. Cross-resistance to entry inhibitors and lenacapavir resistance through Week 52 in study CAPELLA. Antivir Ther. 2023 Dec;28(6):13596535231220754. doi: 10.1177/13596535231220754. PubMed 38085652 ↗
  • Castagna A, Blanco Arevalo JL, Molina JM, Antinori A, Castelli F, Yazdanpanah Y, et al. Follow-Up of Injection Site Reactions in Clinical Studies of People Using Lenacapavir Every 6 Months for HIV Treatment [Poster eP.A.104]. Presented at: European AIDS Conference (EACS), 2023 October 18-21
  • Margot N, Jogiraju V, VanderVeen L, Naik V, Dvory-Sobol H, Rhee MS, et al. Resistance Analysis of Long-Acting Lenacapavir in Heavily Treatment-Experienced People with HIV after 104 Weeks of Treatment [PS8 O4]. Presented at: European AIDS Conference (EACS), 2023 18-21 October
  • Ogbuagu O, DeJesus E, Berhe M, Richmond GJ, Ruane PJ, Sinclair GI, et al. Efficacy and Safety of Long-Acting Subcutaneous Lenacapavir in Heavily Treatment-Experienced People with Multi-Drug Resistant HIV: Week 104 Results [Poster 1596]. Presented at: IDWeek, 2023 11-15 October
  • Ogbuagu O, Segal-Maurer S, Ratanasuwan W, Avihingsanon A, Brinson C, Workowski K, Antinori A, Yazdanpanah Y, Trottier B, Wang H, Margot N, Dvory-Sobol H, Rhee MS, Baeten JM, Molina JM; GS-US-200-4625 investigators. 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;10(8):e497-e505. doi: 10.1016/S2352-3018(23)00113-3. Epub 2023 Jul 11. PubMed 37451297 ↗
  • Ogbuagu O, Avihingsanon A, Segal-Maurer S, Wang H, Rhee MS, Dvory-Sobol H, et al. Lenacapavir Oral Bridging (300 mg QW) Maintains Efficacy with a Similar Safety Profile When SC LEN Cannot Be Administered [Oral OAB0205] Presented at:12th International AIDS Society (IAS) Conference on HIV Science, 2023 23-26 July.
  • Margot NA, Naik V, VanderVeen L, Anoshchenko O, Singh R, Dvory-Sobol H, Rhee MS, Callebaut C. Resistance Analyses in Highly Treatment-Experienced People With Human Immunodeficiency Virus (HIV) Treated With the Novel Capsid HIV Inhibitor Lenacapavir. J Infect Dis. 2022 Nov 28;226(11):1985-1991. doi: 10.1093/infdis/jiac364. PubMed 36082606 ↗
  • Antinori A, Castelli F, Ronot-Bregigeon S, Yazdanpanah Y, Safran R, S. Berger DS, et al. Common Adverse Events in Clinical Studies of People Using Lenacapavir for HIV Treatment [P027]. Presented at: HIV Glasgow 2022, October 23-26
  • Ogbuagu O, Segal-Maurer S, Ratanasuwan W, Trottier B,4 Brunetta J, Shirasaka T, et al. Efficacy and Safety of Long-Acting Subcutaneous Lenacapavir in Heavily Treatment-Experienced People With Multi-Drug Resistant HIV: Week 52 Results [Oral 1585]. Presented at: IDWeek 2022, October 19-23
  • Castagna A, J Blanco JL, Hung CC, Rassool M, Ramgopal MN, Sanchez W, et al. Week 52 Subgroup Efficacy Analyses of Long-Acting Subcutaneous Lenacapavir in Phase 2/3 in Heavily Treatment-Experienced People With Multidrug-Resistant HIV (CAPELLA Study) [P026]. Presented at: HIV Glasgow, 2022 October 23-26
  • Kumar P, Gupta S, Segal-Maurer S, Ogbuagu O, McDonald C, Brinson C, et al. Injection-Site Reaction Experience in Clinical Studies of People Using Lenacapavir For HIV Treatment [Poster EPB184]. Presented at: AIDS, 2022 29 July-2 August
  • Segal-Maurer S, DeJesus E, Stellbrink HJ, Castagna A, Richmond GJ, Sinclair GI, Siripassorn K, Ruane PJ, Berhe M, Wang H, Margot NA, Dvory-Sobol H, Hyland RH, Brainard DM, Rhee MS, Baeten JM, Molina JM; CAPELLA Study Investigators. Capsid Inhibition with Lenacapavir in Multidrug-Resistant HIV-1 Infection. N Engl J Med. 2022 May 12;386(19):1793-1803. doi: 10.1056/NEJMoa2115542. PubMed 35544387 ↗
  • Margot N, Laurie VanderVeen L, Naik V, Chang S, Parvangada PC, Martin R, et al. Resistance Analysis of Long-Acting Lenacapavir in Highly Treatment-Experienced People with HIV After 26 Weeks of Treatment [Oral OS1/1]. Presented at: European AIDS Conference (EACS); 2021 October 27-30
  • Stellbrink HJ, DeJesus E, Segal-Maurer S, Castagna A, Avihingsanon A, Blanco Arevalo JL, et al. Subgroups Efficacy Analyses of Long-Acting Subcutaneous Lenacapavir in Phase 2/3 in Heavily Treatment-Experienced People with HIV (CAPELLA study) [Abstract PE2/69]. Presented at: European AIDS Conference (EACS); 2021 October 27-30
  • Segal-Maurer S, Castagna A, Berhe M, et al. Potent Antiviral Activity of Lenacapavir in Phase 2/3 in Heavily ART-Experienced PWH [Abstract 127]. Presented at: Conference on Retroviruses and Opportunistic Infections; 2021 March 6-10
  • Ogbuagu O, Wiznia A, McGowan JP, Berger DS, Creticos CM, Hagins D, Hodge T, Osiyemi O, Sims J, Wheeler DA, Wang H, Margot NA, Dvory-Sobol H, Rhee MS, Segal-Maurer S, Molina JM. Subcutaneous Lenacapavir in People With Multidrug-Resistant HIV-1: 156 Week Results of the CAPELLA Study. Open Forum Infect Dis. 2025 Dec 19;13(1):ofaf763. doi: 10.1093/ofid/ofaf763. eCollection 2026 Jan. PubMed 41459297 ↗
  • Margot NA, Jogiraju V, Pennetzdorfer N, Naik V, VanderVeen LA, Ling J, Singh R, Dvory-Sobol H, Ogbuagu O, Segal-Maurer S, Molina JM, Rhee MS, Callebaut C. Resistance Analyses in Heavily Treatment-Experienced People With HIV Treated With the Novel HIV Capsid Inhibitor Lenacapavir After 2 Years. J Infect Dis. 2025 Jun 2;231(5):1239-1245. doi: 10.1093/infdis/jiaf050. PubMed 39873394 ↗
  • Ogbuagu OE, Avihingsanon A, Segal-Maurer S, Wang H, Jogiraju VK, Singh R, Rhee MS, Dvory-Sobol H, Sklar PA, Molina JM. Efficacy, safety, and pharmacokinetics of lenacapavir oral bridging when subcutaneous lenacapavir cannot be administered. AIDS. 2025 May 1;39(6):639-648. doi: 10.1097/QAD.0000000000004142. Epub 2025 Feb 10. PubMed 39912752 ↗
  • Ogbuagu O, Molina JM, Chetchotisakd P, Ramgopal MN, Sanchez W, Brunetta J, Castelli F, Crofoot GE, Hung CC, Ronot-Bregigeon S, Margot NA, Wang H, Dvory-Sobol H, Rhee MS, Segal-Maurer S. Efficacy and Safety of Long-Acting Subcutaneous Lenacapavir in Heavily Treatment-Experienced People with Multidrug-Resistant HIV-1: Week 104 Results of a Phase 2/3 Trial. Clin Infect Dis. 2025 Mar 17;80(3):566-574. doi: 10.1093/cid/ciae423. PubMed 39206943 ↗

Study documents

  • Study protocol · Sep 1, 2020
  • Study protocol · May 22, 2024
  • Statistical analysis plan · Sep 30, 2020
  • Statistical analysis plan · Apr 19, 2021
  • Statistical analysis plan · Apr 11, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

1 registry update since Sep 25, 2026
Study completion
Jan 2027→Jan 2028
Oct 1, 2026
Show all 1 update
  1. Oct 1, 2026
    Study completion Jan 2027→Jan 2028
    + 2 other changes: identifiers and verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

11

Registry details

Key details

Study ID
NCT04150068
Lead sponsor
Gilead Sciences
Responsible party
Sponsor
First posted
Nov 4, 2019
Start date
Nov 21, 2019
Primary completion
Oct 5, 2020
Completion
Jan 2028 (estimated)
Results posted
Oct 20, 2021
Last update
Oct 1, 2026

Study contacts

Gilead Study Director
study director · Gilead Sciences

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Gilead Sciences

Start the discussion