CLINICAL TRIALS PROFILE FOR COBICISTAT; DARUNAVIR

All Clinical Trials for COBICISTAT; DARUNAVIR

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00855335 ↗	A Single-arm, Open-label, Study to Assess the Pharmacokinetics of Darunavir and Ritonavir, Darunavir and Cobicistat, Etravirine, and Rilpivirine in HIV-1 Infected Pregnant Women	Completed	Janssen Scientific Affairs, LLC	Phase 3	2009-04-09	The purpose of this study is to study how changes in the body during pregnancy influence the blood levels of TMC114 (darunavir) and ritonavir taken together, darunavir and cobicistat taken as a fixed-dose combination, TMC125 (etravirine) taken alone or with darunavir and ritonavir or rilpivirine in patients with human immunodeficiency virus-1 (HIV-1). This study will examine how these drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time. Any pregnant woman who is currently receiving darunavir with ritonavir, darunavir with cobicistat, etravirine or rilpivirine for HIV-1, and who meets the eligibility criteria for the study, will be allowed to enroll. Patients must be willing to remain on study medication during the course of their pregnancy, and 12 weeks postpartum. The information collected may help answer questions about how to best prescribe these three drugs for pregnant women.
NCT01440569 ↗	Safety and Efficacy of Cobicistat-boosted Darunavir in HIV Infected Adults	Completed	Janssen Research & Development, LLC	Phase 3	2011-09-01	This study is to evaluate the safety and tolerability of cobicistat-boosted darunavir plus two fully active nucleoside analogue reverse transcriptase inhibitors in HIV 1 infected, antiretroviral treatment-naive and treatment-experienced adults with no darunavir (DRV) resistance-associated mutations. After the Week 48 Visit, participants will be given the option to participate in an open-label rollover phase to receive cobicistat and attend visits every 12 weeks until it becomes commercially available, or until Gilead Sciences elects to terminate development of cobicistat.
NCT01440569 ↗	Safety and Efficacy of Cobicistat-boosted Darunavir in HIV Infected Adults	Completed	Gilead Sciences	Phase 3	2011-09-01	This study is to evaluate the safety and tolerability of cobicistat-boosted darunavir plus two fully active nucleoside analogue reverse transcriptase inhibitors in HIV 1 infected, antiretroviral treatment-naive and treatment-experienced adults with no darunavir (DRV) resistance-associated mutations. After the Week 48 Visit, participants will be given the option to participate in an open-label rollover phase to receive cobicistat and attend visits every 12 weeks until it becomes commercially available, or until Gilead Sciences elects to terminate development of cobicistat.
NCT01565850 ↗	D/C/F/TAF Versus COBI-boosted DRV Plus FTC/TDF in HIV-1 Infected, Antiretroviral Treatment Naive Adults	Completed	Gilead Sciences	Phase 2	2012-04-01	This study is to evaluate the safety and efficacy darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed dose combination (FDC) tablet versus darunavir (DRV)+cobicistat (COBI)+emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) in HIV-1 infected, antiretroviral treatment-naive adults as determined by the achievement of HIV-1 RNA < 50 copies/mL at Week 24.

Clinical Trial Conditions for COBICISTAT; DARUNAVIR

Condition Name

Condition Name for COBICISTAT; DARUNAVIR
Intervention	Trials
HIV Infections	9
Healthy	9
HIV	6
HIV-1	5

Condition MeSH

Condition MeSH for COBICISTAT; DARUNAVIR
Intervention	Trials
HIV Infections	21
Acquired Immunodeficiency Syndrome	12
Immunologic Deficiency Syndromes	8
COVID-19	5

Clinical Trial Locations for COBICISTAT; DARUNAVIR

Trials by Country

Trials by Country for COBICISTAT; DARUNAVIR
Location	Trials
United States	169
Spain	17
Canada	12
Belgium	9
United Kingdom	6

Trials by US State

Trials by US State for COBICISTAT; DARUNAVIR
Location	Trials
Texas	14
Georgia	12
California	9
Florida	9
District of Columbia	8

Clinical Trial Progress for COBICISTAT; DARUNAVIR

Clinical Trial Phase

Clinical Trial Phase for COBICISTAT; DARUNAVIR
Clinical Trial Phase	Trials
PHASE4	2
Phase 4	16
Phase 3	11

Clinical Trial Status

Clinical Trial Status for COBICISTAT; DARUNAVIR
Clinical Trial Phase	Trials
Completed	33
Not yet recruiting	6
Recruiting	6

Clinical Trial Sponsors for COBICISTAT; DARUNAVIR

Sponsor Name

Sponsor Name for COBICISTAT; DARUNAVIR
Sponsor	Trials
Janssen Scientific Affairs, LLC	8
Janssen Research & Development, LLC	7
Gilead Sciences	7

Sponsor Type

Sponsor Type for COBICISTAT; DARUNAVIR
Sponsor	Trials
Industry	44
Other	44
NIH	2

Clinical Trials Update, Market Analysis, and Projection for Cobicistat and Darunavir

Last updated: October 30, 2025

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Introduction

Cobicistat and Darunavir are pivotal antiretroviral agents used in the treatment of HIV/AIDS. Their combination has been instrumental in enhancing therapeutic efficacy, especially in fixed-dose formulations. Recent developments in clinical trials, coupled with a shifting market landscape driven by innovative therapies and regulatory dynamics, necessitate a comprehensive analysis to inform stakeholders' strategic decisions.

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Clinical Trials Landscape

Cobicistat

Cobicistat, marketed as a pharmacoenhancer due to its CYP3A enzyme inhibition, boosts the plasma concentrations of other antiretrovirals like Darunavir. Its clinical development primarily focuses on optimizing HIV treatment regimens and evaluating its safety and efficacy in diverse populations.

Recent Phase III trials, such as the GS-6207 study (ongoing), investigate cobicistat's utility in co-infection settings and its potential as a pharmacokinetic enhancer in novel regimens. Regulatory agencies have approved cobicistat for use in combination with Darunavir, as seen in Janssen’s Prezista (Darunavir) and Stribild formulations.

Darunavir

Darunavir, a protease inhibitor, continues to be a cornerstone of HIV therapy. Historically, numerous clinical trials have established its potency and resistance barrier.

Recent trials have focused on:

• Long-acting formulations: Phase II/III studies evaluating injectables like Janssen's Janssen’s Investigational Long-Acting Darunavir aim to improve adherence and reduce pill burden.

• Resistance profiles: Ongoing studies assess Darunavir's effectiveness against emerging resistant HIV strains in treatment-naïve and experienced patients.

• Pediatric evaluations: Trials expanding age indications, including pediatric formulations, are underway, aiming to broaden access.

Market Dynamics and Competitive Landscape

Market Size and Growth Trajectory

The global HIV therapeutics market was valued at approximately $28 billion in 2022 and is projected to grow at a CAGR of around 5% from 2023 to 2030 (source: MarketsandMarkets). Cobicistat and Darunavir occupy a significant share, driven by the persistent global HIV burden and the transition toward fixed-dose combinations (FDCs).

Key Market Players

• Janssen Pharmaceuticals: Holds flagship products like Prezista and Stribild, integrating cobicistat.
• Gilead Sciences: Offers alternative protease inhibitors and boosting agents.
• ViiV Healthcare: Focuses on innovative regimens incorporating integrase inhibitors.

Market Trends

• Shift to Long-acting Regimens: Injectable formulations of Darunavir and other agents aim to improve adherence, potentially disrupting oral therapy markets.
• Generic Penetration: Patent expirations in mature markets have increased generic competition, impacting revenue streams of branded drugs.
• Regulatory Approvals: Expanding FDA and EMA approvals for regimens incorporating cobicistat bolster market potential.

Market Projection and Future Outlook

Growth Drivers

• Increasing HIV prevalence: Approximately 38 million people globally were living with HIV in 2022, with higher prevalence in sub-Saharan Africa and emerging markets.
• Expanding indications: Pediatric use, pre-exposure prophylaxis (PrEP), and treatment-naïve populations expand potential markets.
• Pipeline innovations: Long-acting injectables and novel combinations promise to transform treatment paradigms.

Challenges

• Resistance and adverse effects: Concerns over drug resistance and side effects may influence prescribing patterns.
• Pricing and reimbursement policies: Cost constraints hinder access in low-income regions.
• Competition from new classes: Entry of drugs from other classes (e.g., integrase inhibitors) shifts market dynamics.

Forecast (2023-2030)

• The combined market for cobicistat and Darunavir is expected to reach $10 billion globally by 2030, growing at a CAGR of approximately 4-6%.

• The segment will likely see increased adoption of long-acting formulations, accounting for up to 30% of the antiretroviral market by 2030.

• The emergence of biosimilars and generics will exert downward pressure on prices, especially in emerging economies.

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Strategic Implications for Stakeholders

• Pharmaceutical companies should prioritize innovation in long-acting formulations and explore broader indications (e.g., PrEP, pediatric use).
• Investors must monitor regulatory approvals and pipeline developments for early signals of market shifts.
• Healthcare providers should stay current on emerging resistance data and updated treatment guidelines to optimize therapy.

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Key Takeaways

• Clinical trials primarily focus on expanding long-acting formulations and addressing resistance issues for both Cobicistat and Darunavir.
• The market remains substantial, powered by increasing global HIV prevalence, but faces headwinds from generics and evolving treatment standards.
• The long-term outlook favors innovations like injectable regimens, with significant growth expected in markets adopting these technology shifts.
• Stakeholders should align R&D and commercial strategies with emerging trends in therapy personalization and adherence improvement tools.

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FAQs

1. What is the role of Cobicistat in HIV therapy?
   Cobicistat functions as a pharmacokinetic booster by inhibiting CYP3A enzymes, increasing plasma levels of co-administered antiretroviral drugs like Darunavir, thus enhancing efficacy.

2. Are there any new clinical trials for Cobicistat?
   Yes, ongoing studies investigate cobicistat's utility in long-acting formulations and combination therapies, aiming to improve adherence and tolerability.

3. How does Darunavir compare to other protease inhibitors?
   Darunavir boasts a high resistance barrier, efficacy in resistant strains, and a favorable side-effect profile relative to older protease inhibitors.

4. What are the prospects for long-acting Darunavir formulations?
   Long-acting Darunavir injectables are in advanced clinical trials, with promising results indicating potential commercialization within the next few years.

5. How will market dynamics influence pricing strategies?
   Increased competition from generics and biosimilars, coupled with innovation-driven premium offerings, will necessitate adaptive pricing strategies to balance access and profitability.

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References

[1] MarketsandMarkets. "HIV Therapeutics Market by Drug Class, Region - Global Forecast to 2030." 2022.
[2] Janssen Pharmaceuticals. Product pipeline and clinical trial disclosures.
[3] U.S. Food and Drug Administration. Drug approval and safety updates (2022-2023).
[4] Gilead Sciences. Annual Report 2022.