Advancing the Treatment of HIV-1-Infection: Gilead Sciences Phase 2 Clinical Trials and What They Mean

Trends in Gilead's HIV-1 Phase 2 Trials Over Two Decades

Explore the evolution of Phase 2 clinical trials for HIV-1 infection sponsored by Gilead Sciences over the past two decades. This analysis provides insights into the frequency and distribution of trials, highlighting key trends and potential implications for future research.

Key Insights:

  1. Steady Growth Over Time: From 2005 to 2025, there is a noticeable increase in the number of trials, with a peak in 2024 where 3 trials were initiated. This suggests a growing commitment to advancing HIV-1 treatment options.

  2. Recent Surge in Trials: The years 2019 and 2022 both saw a doubling in the number of trials compared to previous years, indicating a renewed focus and possibly the introduction of new therapeutic strategies or compounds.

  3. Consistent Efforts in the 2010s: Between 2011 and 2018, Gilead maintained a consistent pace with 1 trial almost every other year, reflecting a stable research pipeline during this period.

  4. Significant Increase in 2024: The year 2024 stands out with the highest number of trials (3), which is a 50% increase compared to the previous peak years. This could be indicative of breakthroughs in research or the introduction of multiple new study arms.

  5. Future Prospects: With 1 trial already planned for 2025, Gilead continues to demonstrate its commitment to HIV-1 research, potentially paving the way for innovative treatments and improved patient outcomes.

These trends underscore Gilead Sciences' ongoing dedication to combating HIV-1 infection through robust clinical research, with an emphasis on increasing trial frequency and exploring diverse therapeutic avenues.

Top Interventions in Gilead's Phase 2 HIV-1 Clinical Trials

Gilead Sciences is at the forefront of HIV-1 infection treatment research, with a diverse range of interventions in Phase 2 clinical trials. Here are some key insights from the data:

  • Top Interventions: The most frequently tested interventions, each appearing in 3 trials, are B/F/TAF, BIC, Oral Lenacapavir, RTV, and Subcutaneous Lenacapavir. This indicates a strong focus on these drugs in Gilead's research pipeline.

  • Diverse Drug Portfolio: Gilead's trials feature a wide array of drugs, with 20 different interventions being tested. This diversity highlights Gilead's commitment to exploring multiple therapeutic avenues for HIV-1 infection.

  • Focus on Lenacapavir: Both Oral and Subcutaneous Lenacapavir are prominently featured, each in 3 trials. This suggests a significant interest in the potential of Lenacapavir as a versatile treatment option.

  • Combination Therapies: Several trials involve combination therapies, such as BIC/LEN FDC and Bictegravir/emtricitabine/tenofovir alafenamide, each appearing in 2 trials. This reflects a strategic approach to enhance treatment efficacy through drug combinations.

  • Placebo-Controlled Studies: The presence of placebos, such as Placebo to Match BVY and Placebo to Match GS1720/GS-4182 FDC, each in 2 trials, underscores the rigorous scientific methodology employed in these trials to ensure reliable results.

Gilead Sciences' robust Phase 2 clinical trial program demonstrates their dedication to advancing HIV-1 treatment through innovative and diverse therapeutic strategies.

Gilead Sciences' Phase 2 HIV-1 Trials: Recruitment Status Overview

Key Insights into Gilead Sciences' Phase 2 HIV-1 Clinical Trials:

  • Completed Trials Lead the Pack: With 7 trials completed, this category represents the largest portion of the trials, accounting for approximately 37% of the total. This indicates a strong progression towards potential treatments.

  • Active but Not Recruiting: There are 6 trials that are active but not recruiting, making up about 32% of the trials. This suggests that these trials are in the later stages of data collection or analysis.

  • Recruitment Challenges: Only 2 trials are currently recruiting, which is about 11% of the total. This could imply challenges in finding suitable participants or a strategic focus on completing existing trials.

  • Early Stage Trials: A single trial is in the 'Not Yet Recruiting' phase, representing 5% of the total. This indicates a potential new avenue for research that is still in the preparatory stages.

  • Terminated Trials: With 1 trial terminated, this accounts for 5% of the trials. While terminations can occur for various reasons, it highlights the challenges and complexities involved in clinical research.

These insights provide a snapshot of Gilead Sciences' commitment to advancing HIV-1 treatment through a robust pipeline of clinical trials, with a significant focus on completing and analyzing existing studies.

Trial IDBrief TitleTrial PhasesSponsorsInterventionsEnrollmentConditionsStart DateCompletion DateLast UpdateStatus
NCT06544733

Study of Oral Weekly GS-1720 and GS-4182 Versus Biktarvy in People With HIV-1 Who Are Virologically Suppressed

Phase 2, Phase 3
Gilead Sciences

GS-1720, GS-4182, Placebo to Match BVY, Bictegravir/emtricitabine/tenofovir alafenamide, GS-1720/GS-4182 FDC, Placebo to Match GS1720/GS-4182 FDC

675(Estimated)HIV-1-InfectionAug 20, 2024Jun 1, 2029Dec 30, 2024
Unknown status
NCT05729568

A Study of GS-5423 and GS-2872 in Combination With Capsid Inhibitor Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection

Phase 2
Gilead Sciences

Teropavimab, Zinlirvimab, Lenacapavir Tablet, Lenacapavir Injection, Antiretroviral Therapy

83(Actual)HIV InfectionsMay 15, 2023Dec 1, 2029Jan 13, 2025
Unknown status
NCT00445146

Safety of EVG+RTV Administered With Other Antiretroviral Agents for the Treatment of HIV-1 Infection

Phase 2
Gilead Sciences

EVG, RTV, ARV regimen

192(Actual)HIV InfectionsFeb 1, 2007Mar 1, 2015Apr 25, 2016
CompletedHas Results
NCT04143594

Study to Evaluate the Safety and Efficacy of Lenacapavir (GS-6207) in Combination With Other Antiretroviral Agents in People Living With HIV

Phase 2
Gilead Sciences

Oral Lenacapavir, F/TAF, Subcutaneous Lenacapavir, TAF, BIC, B/F/TAF

183(Actual)HIV-1-infectionNov 22, 2019Sep 19, 2023Oct 2, 2024
CompletedHas Results
NCT02397694

Safety and Efficacy of Bictegravir + Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

Phase 2
Gilead Sciences

BIC, F/TAF, DTG, BIC Placebo, DTG Placebo, B/F/TAF

98(Actual)HIV-1 InfectionMar 23, 2015Feb 27, 2019Apr 7, 2020
CompletedHas Results
NCT02881320

Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination in Adolescents and Children With Human Immunodeficiency Virus-1

Phase 2, Phase 3
Gilead Sciences

B/F/TAF (Adult Strength), B/F/TAF (Low Dose), B/F/TAF (TOS), B/F/TAF (TOS), B/F/TAF (TOS), B/F/TAF (TOS)

177(Actual)HIV-1 InfectionSep 21, 2016Sep 1, 2025Oct 30, 2024
Unknown status
NCT01286740

Study to Evaluate Switching From a Regimen Consisting of the Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (STR) to the Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate STR

Phase 2
Gilead Sciences

FTC/RPV/TDF

50(Actual)HIV-1 InfectionJan 1, 2011Mar 1, 2012Apr 26, 2013
CompletedHas Results
NCT00892437

Safety and Efficacy of Cobicistat-boosted Atazanavir Compared to Ritonavir-boosted Atazanavir in Combination With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

Phase 2
Gilead Sciences

COBI, RTV, ATV, FTC/TDF, COBI placebo, RTV placebo

85(Actual)HIV-1 InfectionMay 1, 2009Jan 1, 2015Feb 15, 2016
CompletedHas Results
NCT05281510

Study of VRC07-523LS, CAP256V2LS, and Vesatolimod, in Early Antiretroviral-treated HIV-1 Clade C-infected Women

Phase 2
Gilead Sciences

Vesatolimod, VRC07523LS, CAP256V2LS

20(Actual)HIV-1-infectionJun 9, 2022Jan 16, 2025Jan 30, 2025
Completed
NCT00743340

Rollover Study Protocol for Pediatric Patients in South Africa for Continued Access to Emtricitabine

Phase 2
Gilead Sciences

Emtricitabine

50(Actual)HIV-1 InfectionNov 22, 2005Feb 13, 2017Apr 26, 2018
CompletedHas Results
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