Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04143594 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate the Safety and Efficacy of Lenacapavir (GS-6207) in Combination With Other Antiretroviral Agents in People Living With HIV
A Phase 2 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 183
- Enrollment target
NCT04143594: Completed Phase 2 study, sponsored by Gilead Sciences.
NCT04143594 is a Phase 2 study that has completed, run by Gilead Sciences. The registered enrollment target is 183 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04143594, a Phase 2 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 183 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the efficacy of lenacapavir (formerly GS-6207) containing regimens in people living with human immunodeficiency virus (HIV) (PLWH).
Primary Outcome
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 54 was analyzed using the 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. Week 54 window was between Day 323 and 413 (inclusive). Percentages were rounded off.
Interventions
- DRUG TAF
- DRUG Oral Lenacapavir
- DRUG Subcutaneous Lenacapavir
- DRUG F/TAF
- DRUG BIC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 183 participants |
| Start Date | 2019-11-22 |
| Est. Completion | 2023-09-19 |
| Phase | Phase 2 |
What the finished NCT04143594 record still lists
NCT04143594 is an interventional study that assigns participants to a tested intervention. The registered 183 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% higher).
The record links to 0 conditions, and to 5 interventions - of which TAF is the first listed.
NCT04143594 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04143594 about?
NCT04143594 is a clinical study titled "Study to Evaluate the Safety and Efficacy of Lenacapavir (GS-6207) in Combination With Other Antiretroviral Agents in People Living With HIV". The primary objective of this study is to evaluate the efficacy of lenacapavir (formerly GS-6207) containing regimens in people living with human immunodeficiency virus (HIV) (PLWH).
What is the current status of trial NCT04143594?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 183 participants. The study started on 2019-11-22. Estimated completion is 2023-09-19.
What interventions are being tested in trial NCT04143594?
The interventions under investigation include: TAF (DRUG), Oral Lenacapavir (DRUG), Subcutaneous Lenacapavir (DRUG), F/TAF (DRUG), BIC (DRUG).
Who is sponsoring clinical trial NCT04143594?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04143594's enrollment target sits among peer trials
183 363rd of 2000 higher than 1,638 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03859297 · 183 participants · NA
Mechanisms of Rumination Change in Adolescent Depression
- NCT04270591 · 183 participants · Phase 1
Assessment of Anti-tumor and Safety in Glumetinib in Patients With c-MET-positive Non-Small Cell Lung Cancer
- NCT06764615 · 183 participants · Phase 2
A Continuation Study of TAK-279 in Adults With Ulcerative Colitis (UC) and Crohn's Disease (CD)
- NCT06872684 · 183 participants · NA
Safety and Efficacy of Endovascular Treatment of Intracranial Aneurysms With Surpass Elite With GUARDian Flow Diverter (GUARD)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI