Trial · NCT04994509
Pre-Exposure Prophylaxis Study of Lenacapavir and Emtricitabine/Tenofovir Alafenamide in Adolescent Girls and Young Women at Risk of HIV Infection
NCT04994509, Phase 3, Active not recruiting, Gilead Sciences; results first posted 2025-06-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pre-Exposure Prophylaxis Study of Lenacapavir and Emtricitabine/Tenofovir Alafenamide in Adolescent Girls and Young Women at Risk of HIV Infection. Trials, record NCT04994509. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04994509
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pre-Exposure Prophylaxis Study of Lenacapavir and Emtricitabine/Tenofovir Alafenamide in Adolescent Girls and Young Women at Risk of HIV Infection
- NCT number
- NCT04994509
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 5,368 participants, actual
- Lead sponsor
- Gilead Sciences
- Conditions
- Pre-Exposure Prophylaxis of HIV Infection
- Interventions
- Oral Lenacapavir (LEN), Subcutaneous (SC) Lenacapavir (LEN), F/TAF, F/TDF, Placebo SC LEN, PTM Oral LEN, PTM F/TAF, PTM F/TDF
- First posted
- 2021-08-06
- Last updated
- 2026-10-16
- Other registries' IDs
- eudract:2023-001024-42
- Results first posted
- 2025-06-19
- Limitations and caveats
Due to data monitoring committee recommendation to stop the study early if the prespecified evaluation criteria were met, this is the date by when at least 50% of the participants were followed up for at least 52 weeks in the study.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence Phase: Recent Infection Testing Algorithm (RITA) Estimate of the Background Human Immunodeficiency-1 Virus Infection Incidence Rate (bHIV) Per 100 Person Years (PY) | Incidence Phase Screening Visit (Day 1) | bHIV per 100 PY in the Incidence Phase was calculated using RITA. The RITA incorporated HIV-1 testing results and recency assay testing results to estimate the bHIV. Recency assay testing was performed for participants in the All Screened Set found to have HIV-1 infection at the Incidence Phase Screening Visit as defined below. Participants were considered to have recent HIV-1 infection if the normalized optical density (ODn) was below 1.5 threshold using the Sedia limiting antigen avidity enzyme immunoassay (LAg-EIA) and the HIV-1 RNA (viral load) was \> 75 copies/mL of blood. HIV-1 infection was defined as participants having at least one of the following central lab results at the Incidence Phase screening visit: * Positive HIV-1/2 differentiation Ab, OR * Positive HIV-1 ribonucleic acid (RNA) qualitative test, OR * HIV-1 RNA quantitative test ≥200 copies/mL. |
| Primary | Randomized Blinded Phase: HIV-1 Incidence Reported Per 100 PY for LEN and F/TAF Compared to Participants in All Screened Set | When at least 50% of the participants completed 52 weeks of follow-up after randomization or permanently discontinued from the study (maximum 143 weeks) | HIV-1 incidence per 100 PY for LEN and F/TAF was calculated as the number of participants who acquired HIV-1 divided by the total of a) for participants not diagnosed with HIV-1, sum of all duration of follow-up time in years, while at risk of HIV-1 infection (where a year is 365.25 days) and b) for participants diagnosed with HIV-1, sum of all duration of follow-up time up to confirmed HIV-1 diagnoses. HIV-1 diagnosis was determined by an HIV adjudication committee who reviewed potential HIV-1 infection events in the randomized participants. The committee, in a blinded, consistent, and unbiased manner, determined whether HIV test results confirmed HIV-1 infection and determined the date of diagnosis for each case, defined as the date of the earliest study visit with evidence of HIV infection considering both prospective HIV testing and back-testing of archived samples. bHIV incidence per 100 PY in All Screened Set was estimated as described in outcome measure#1. |
| Secondary | Randomized Blinded Phase: HIV-1 Incidence Reported Per 100 PY for LEN, F/TAF and F/TDF | When at least 50% of the participants completed 52 weeks of follow-up after randomization or permanently discontinued from the study (maximum 143 weeks) | HIV-1 incidence per 100 PY was calculated as the number of participants who acquired HIV-1 divided by the total of a) for participants not diagnosed with HIV-1, sum of all duration of follow-up time in years, while at risk of HIV-1 infection (where a year is 365.25 days) and b) for participants diagnosed with HIV-1, sum of all duration of follow-up time up to confirmed HIV-1 diagnoses. HIV-1 diagnosis was determined by an HIV adjudication committee who reviewed potential HIV-1 infection events in the randomized participants. The committee, in a blinded, consistent, and unbiased manner, determined whether HIV test results confirmed HIV-1 infection and determined the date of diagnosis for each case, defined as the date of the earliest study visit with evidence of HIV infection considering both prospective HIV testing and back-testing of archived samples. |
| Secondary | Randomized Blinded Phase: HIV-1 Incidence Among Participants Adherent to LEN | When at least 50% of the participants completed 52 weeks of follow-up after randomization or permanently discontinued from the study (maximum 143 weeks) | A participant was defined as adherent to LEN if they have received all per-protocol administrations of LEN within 28 weeks since the previous administration. The incidence of HIV-1 infection per 100 PY calculation is defined in outcome measure #2. |
| Secondary | Randomized Blinded Phase: Percentage of Participants Adherent to F/TAF in HIV-1 Diagnosed Participants and Their Matched Controls | When at least 50% of the participants completed 52 weeks of follow-up after randomization or permanently discontinued from the study (maximum 143 weeks) | A participant's adherence to F/TAF was measured by tenofovir diphosphate (TFV-DP) in dried blood spot (DBS) samples, where \<450 fmol/punch associates with an adherence of \<2 days per week. The data is reported in two categories: low adherence (\<2 days per week) and not low adherence (\>= 2 days per week). |
| Secondary | Randomized Blinded Phase: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) | Up to 165 weeks | TEAEs were defined as 1 or both of the following: * Any adverse events (AEs) leading to premature discontinuation of study drug, or * Any AEs with an onset date on or after the study drug start date and no later than the last exposure date after permanent discontinuation of the study drug. * An AE was any untoward medical occurrence in a clinical study participant administered a study drug that did not necessarily had a causal relationship with the treatment. The severity of the AEs was graded using the division of AIDS (DAIDS) toxicity grading scale version 2.1. The DAIDS grading table provides an AE severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines : Grade 1 indicates a mild event, Grade 2 indicates a moderate event, Grade 3 indicates a severe event, Grade 4 indicates a potentially life-threatening event, Grade 5 indicates death. Percentages were rounded off. |
| Secondary | Randomized Blinded Phase: Percentage of Participants With Grade 3 or Higher Laboratory Abnormalities | Up to 165 weeks | Treatment-emergent laboratory abnormalities were defined as values that increased at least 1 toxicity grade from baseline at any post-baseline visit, up to and including the last exposure date for participants who permanently discontinued study drug, or the last available date in the database snapshot for participants who were still on treatment at the time of an analysis. The DAIDS Toxicity Grading Scale, Version 2.1 was used to assign toxicity grades (0 to 4) to laboratory results for analysis. Grade 0 included all values that do not meet the criteria for an abnormality of at least Grade 1. Grade 1 mild, Grade 2 moderate, Grade 3 severe, and Grade 4 potentially life-threatening. Percentages were rounded off. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence Phase: Recent Infection Testing Algorithm (RITA) Estimate of the Background Human Immunodeficiency-1 Virus Infection Incidence Rate (bHIV) Per 100 Person Years (PY) | Incidence Phase Screening Visit (Day 1) | Participants in the All Screened Set were analyzed. The All Screened Set included all participants who were screened for HIV-1 in the Incidence Phase and had a non-missing HIV-1 diagnosis based on HIV test results at Incidence Phase screening. As the outcome measure was assessed prior to Randomized Blinded Phase, the data is reported in one arm consisting of all participants screened in Incidence Phase. | HIV-1 events per 100 person-years | NUMBER |
| PRIMARY | Randomized Blinded Phase: HIV-1 Incidence Reported Per 100 PY for LEN and F/TAF Compared to Participants in All Screened Set | When at least 50% of the participants completed 52 weeks of follow-up after randomization or permanently discontinued from the study (maximum 143 weeks) | Participants in the LEN and F/TAF groups in the Full Analysis Set (FAS) were analyzed. The FAS included all randomized participants who received at least 1 dose of any study drug and had not been diagnosed with HIV-1 on or prior to the first dose date. Per prespecified analysis, HIV-1 incidence for this outcome measure was reported only for participants who received LEN and F/TAF. The HIV-1 incidence was compared with participants in All Screened Set. | HIV-1 events per 100 person-years | NUMBER |
| SECONDARY | Randomized Blinded Phase: HIV-1 Incidence Reported Per 100 PY for LEN, F/TAF and F/TDF | When at least 50% of the participants completed 52 weeks of follow-up after randomization or permanently discontinued from the study (maximum 143 weeks) | Participants in the Full Analysis Set were analyzed. | HIV-1 events per 100 person-years | NUMBER |
| SECONDARY | Randomized Blinded Phase: HIV-1 Incidence Among Participants Adherent to LEN | When at least 50% of the participants completed 52 weeks of follow-up after randomization or permanently discontinued from the study (maximum 143 weeks) | Participants in the Full Analysis Set who were adherent to LEN were analyzed. | HIV-1 events per 100 person-years | NUMBER |
| SECONDARY | Randomized Blinded Phase: Percentage of Participants Adherent to F/TAF in HIV-1 Diagnosed Participants and Their Matched Controls | When at least 50% of the participants completed 52 weeks of follow-up after randomization or permanently discontinued from the study (maximum 143 weeks) | The dried blood spot (DBS) Case-Control Analysis Set included all randomized participants who took at least 1 dose of study drug, were diagnosed with HIV-1 or were selected as a matched control (with no diagnosis of HIV-1) for a participant with HIV-1 and have at least 1 non-missing DBS concentration value reported by the DBS laboratory.~Per pre-specified analysis, the data is reported in a subset of participants in the F/TAF arm with and without HIV-1 diagnosis. | percentage of participants | NUMBER |
| SECONDARY | Randomized Blinded Phase: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) | When all participants have a minimum of 52 weeks of exposure to study drug or permanent discontinuation, whichever occurs first (maximum approximately 3 years) | |||
| SECONDARY | Randomized Blinded Phase: Percentage of Participants Experiencing Clinically Significant Laboratory Abnormalities | When all participants have a minimum of 52 weeks of exposure to study drug or permanent discontinuation, whichever occurs first (maximum approximately 3 years) |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence Phase: Recent Infection Testing Algorithm (RITA) Estimate of the Background Human Immunodeficiency-1 Virus Infection Incidence Rate (bHIV) Per 100 Person Years (PY) | Participants Screened for HIV-1 in Incidence Phase | 2.407 | 95% Confidence Interval 1.815 to 3.191 | HIV-1 events per 100 person-years | |
| Randomized Blinded Phase: HIV-1 Incidence Reported Per 100 PY for LEN and F/TAF Compared to Participants in All Screened Set | Randomized Blinded Phase: Lenacapavir | 0.000 | 95% Confidence Interval 0.000 to 0.190 | HIV-1 events per 100 person-years | |
| Randomized Blinded Phase: HIV-1 Incidence Reported Per 100 PY for LEN and F/TAF Compared to Participants in All Screened Set | Randomized Blinded Phase: F/TAF | 2.018 | 95% Confidence Interval 1.435 to 2.759 | HIV-1 events per 100 person-years | |
| Randomized Blinded Phase: HIV-1 Incidence Reported Per 100 PY for LEN and F/TAF Compared to Participants in All Screened Set | Incidence Phase: All Screened Participants With Non-missing HIV-1 Diagnosis | 2.407 | 95% Confidence Interval 1.815 to 3.191 | HIV-1 events per 100 person-years | |
| Randomized Blinded Phase: HIV-1 Incidence Reported Per 100 PY for LEN, F/TAF and F/TDF | Randomized Blinded Phase: Lenacapavir | 0.000 | 95% Confidence Interval 0.000 to 0.190 | HIV-1 events per 100 person-years | |
| Randomized Blinded Phase: HIV-1 Incidence Reported Per 100 PY for LEN, F/TAF and F/TDF | Randomized Blinded Phase: F/TAF | 2.018 | 95% Confidence Interval 1.435 to 2.759 | HIV-1 events per 100 person-years | |
| Randomized Blinded Phase: HIV-1 Incidence Reported Per 100 PY for LEN, F/TAF and F/TDF | Randomized Blinded Phase: F/TDF | 1.685 | 95% Confidence Interval 0.963 to 2.737 | HIV-1 events per 100 person-years | |
| Randomized Blinded Phase: HIV-1 Incidence Among Participants Adherent to LEN | Randomized Blinded Phase: Lenacapavir | 0.000 | 95% Confidence Interval 0.000 to 0.214 | HIV-1 events per 100 person-years | |
| Randomized Blinded Phase: Percentage of Participants Adherent to F/TAF in HIV-1 Diagnosed Participants and Their Matched Controls | Randomized Blinded Phase: F/TAF (Participants With HIV-1 Diagnosis) | Low (< 2 days/Week) | 91.9 | percentage of participants | |
| Randomized Blinded Phase: Percentage of Participants Adherent to F/TAF in HIV-1 Diagnosed Participants and Their Matched Controls | Randomized Blinded Phase: F/TAF (Matched Controls - Participants With No HIV-1 Diagnosis) | Low (< 2 days/Week) | 65.9 | percentage of participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Randomized Blinded Phase: Lenacapavir | 2,150 | |
| Overall Study | STARTED | Randomized Blinded Phase: F/TAF | 2,145 | |
| Overall Study | STARTED | Randomized Blinded Phase: F/TDF | 1,073 | |
| Overall Study | COMPLETED | Randomized Blinded Phase: Lenacapavir | 94 | |
| Overall Study | COMPLETED | Randomized Blinded Phase: F/TAF | 77 | |
| Overall Study | COMPLETED | Randomized Blinded Phase: F/TDF | 37 | |
| Overall Study | NOT COMPLETED | Randomized Blinded Phase: Lenacapavir | 2,056 | |
| Overall Study | NOT COMPLETED | Randomized Blinded Phase: F/TAF | 2,068 | |
| Overall Study | NOT COMPLETED | Randomized Blinded Phase: F/TDF | 1,036 |
Source ClinicalTrials.gov
Adverse events333
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Randomized Blinded Phase: Lenacapavir | 133 | 2,140 | |
| other | Diarrhoea | Gastrointestinal disorders | Randomized Blinded Phase: F/TAF | 161 | 2,135 | |
| other | Diarrhoea | Gastrointestinal disorders | Randomized Blinded Phase: F/TDF | 67 | 1,070 | |
| other | Nausea | Gastrointestinal disorders | Randomized Blinded Phase: Lenacapavir | 144 | 2,140 | |
| other | Nausea | Gastrointestinal disorders | Randomized Blinded Phase: F/TAF | 234 | 2,135 | |
| other | Nausea | Gastrointestinal disorders | Randomized Blinded Phase: F/TDF | 142 | 1,070 | |
| other | Vomiting | Gastrointestinal disorders | Randomized Blinded Phase: Lenacapavir | 125 | 2,140 | |
| other | Vomiting | Gastrointestinal disorders | Randomized Blinded Phase: F/TAF | 235 | 2,135 | |
| other | Vomiting | Gastrointestinal disorders | Randomized Blinded Phase: F/TDF | 107 | 1,070 | |
| other | Injection site nodule | General disorders | Randomized Blinded Phase: Lenacapavir | 1,365 | 2,140 |
1 to 10 of 333Source ClinicalTrials.gov
See all 333 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Randomized Blinded Phase: Lenacapavir | 0 | 2,150 |
| Total, all-cause mortality | Randomized Blinded Phase: F/TAF | 6 | 2,145 |
| Total, all-cause mortality | Randomized Blinded Phase: F/TDF | 0 | 1,073 |
| Total, other adverse events | Randomized Blinded Phase: Lenacapavir | 1,757 | 2,140 |
| Total, other adverse events | Randomized Blinded Phase: F/TAF | 1,550 | 2,135 |
| Total, other adverse events | Randomized Blinded Phase: F/TDF | 756 | 1,070 |
| Total, serious adverse events | Randomized Blinded Phase: Lenacapavir | 59 | 2,140 |
| Total, serious adverse events | Randomized Blinded Phase: F/TAF | 85 | 2,135 |
| Total, serious adverse events | Randomized Blinded Phase: F/TDF | 35 | 1,070 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39046157 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04994509
GET https://conductscience.org/api/trials/v1/NCT04994509/events?page=2