Trial · NCT07908446
Study of BIC/LEN FDC Versus Stable Baseline Regimens in Virologically Suppressed People With HIV
NCT07908446, Phase 4, Not yet recruiting, Gilead Sciences
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of BIC/LEN FDC Versus Stable Baseline Regimens in Virologically Suppressed People With HIV. Trials, record NCT07908446. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07908446
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of BIC/LEN FDC Versus Stable Baseline Regimens in Virologically Suppressed People With HIV
- NCT number
- NCT07908446
- Status
- Not yet recruiting
- Phases
- Phase 4
- Enrollment
- 400 participants, estimated
- Lead sponsor
- Gilead Sciences
- Conditions
- HIV-1 Infection
- Interventions
- BIC/LEN FDC, Lenacapavir, SBR
- First posted
- 2026-11-02
- Last updated
- 2026-11-02
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Participants With HIV-1 Ribonucleic Acid (RNA) ≥ 50 Copies/mL at Week 24, as Determined by the United States (US) Food and Drug Administration (FDA) Snapshot Algorithm | Week 24 | |
| Secondary | Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 using the US FDA-defined snapshot algorithm | Week 48 | |
| Secondary | Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 Using the US FDA-Defined Snapshot Algorithm | Week 24 | |
| Secondary | Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Using the US FDA-Defined Snapshot Algorithm | Week 48 | |
| Secondary | Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 24 | Baseline, Week 24 | |
| Secondary | Change From Baseline in CD4 Cell Count at Week 48 | Baseline, Week 48 | |
| Secondary | Percentage of Participants Experiencing Treatment-Emergent Grade 3 or 4 Adverse Events (AEs) | First dose date up to Week 48 plus 60 days | |
| Secondary | Percentage of Participants Experiencing Treatment-Emergent Serious Adverse events (SAEs) | First dose date up to Week 48 plus 60 days | |
| Secondary | Percentage of Participants Experiencing Treatment-Emergent AEs Leading to Discontinuation of Study Drug Through Week 48 | Up to week 48 | |
| Secondary | Change From Baseline in Patient-Reported Experience and Satisfaction Score, as Assessed by the Questionnaire to Understand the Experience and Satisfaction in a Study in HIV-Treatment (QUEST-HIV-T) at Week 24 | Baseline, Week 24 | The QUEST-HIV-T is a patient-reported outcome (PRO) measure that evaluates experience and satisfaction in a clinical study for HIV. The measure consists of 16-item that is intended to be completed by PWH during an active treatment period using a recall period of "the past 7 days." The QUEST-HIV-T utilizes 5-point verbal descriptor scales (Not at all-Extremely, Very satisfied-Very dissatisfied). |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT07908446
GET https://conductscience.org/api/trials/v1/NCT07908446/registered