CLINICAL TRIALS PROFILE FOR PREZCOBIX PED

All Clinical Trials for PREZCOBIX PED

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02499978 ↗	Darunavir/Cobicistat and Dolutegravir to Maintain Virologic Suppression and Reduce NRTI-associated Toxicity	Withdrawn	Janssen Scientific Affairs, LLC	Phase 2/Phase 3	2016-05-01	This is a clinical research study to see if switching to Darunavir/Cobicistat ((PREZCOBIX™, DRV/COBI ) and Dolutegrivir (Tivicay®, DTG) in HIV-infected individuals with undetectable HIV viral load on nucleos(t)ide reverse transcriptase inhibitor (NRTI)-containing therapy will be effective in maintaining virologic suppression at 48 weeks of treatment.
NCT02499978 ↗	Darunavir/Cobicistat and Dolutegravir to Maintain Virologic Suppression and Reduce NRTI-associated Toxicity	Withdrawn	University of Colorado, Denver	Phase 2/Phase 3	2016-05-01	This is a clinical research study to see if switching to Darunavir/Cobicistat ((PREZCOBIX™, DRV/COBI ) and Dolutegrivir (Tivicay®, DTG) in HIV-infected individuals with undetectable HIV viral load on nucleos(t)ide reverse transcriptase inhibitor (NRTI)-containing therapy will be effective in maintaining virologic suppression at 48 weeks of treatment.
NCT02499978 ↗	Darunavir/Cobicistat and Dolutegravir to Maintain Virologic Suppression and Reduce NRTI-associated Toxicity	Withdrawn	Stanford University	Phase 2/Phase 3	2016-05-01	This is a clinical research study to see if switching to Darunavir/Cobicistat ((PREZCOBIX™, DRV/COBI ) and Dolutegrivir (Tivicay®, DTG) in HIV-infected individuals with undetectable HIV viral load on nucleos(t)ide reverse transcriptase inhibitor (NRTI)-containing therapy will be effective in maintaining virologic suppression at 48 weeks of treatment.
NCT02603107 ↗	Study to Evaluate the Safety and Efficacy of Switching From Regimens Consisting of Boosted Atazanavir or Darunavir Plus Either Emtricitabine/Tenofovir or Abacavir/Lamivudine to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppres	Completed	Gilead Sciences	Phase 3	2015-11-20	The primary objective of this study is to evaluate the efficacy of switching to a fixed-dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing on a regimen consisting of boosted atazanavir (ATV) or darunavir (DRV) plus either emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or abacavir/lamivudine (ABC/3TC) in HIV-1 infected adults who are virologically suppressed.
NCT02625207 ↗	THE EFFECT OF CYP3A5 GENOTYPE ON THE PHARMACOKINETICS OF MARAVIROC	Completed	Pfizer	Phase 1	2015-11-06	This will be an open-label, parallel group, multiple dose study in approximately 48 healthy male or female subjects of African American and Caucasian self-reported race, to assess the effect of CYP3A5 genotype on the PK of MVC and CYP3A5-derived metabolites. Maraviroc and CYP3A5-derived metabolite PK will also be compared between African-Americans and Caucasians in subjects carrying two copies of the dysfunctional CYP3A5 alleles (*3, *6, and/or *7).
NCT02625207 ↗	THE EFFECT OF CYP3A5 GENOTYPE ON THE PHARMACOKINETICS OF MARAVIROC	Completed	ViiV Healthcare	Phase 1	2015-11-06	This will be an open-label, parallel group, multiple dose study in approximately 48 healthy male or female subjects of African American and Caucasian self-reported race, to assess the effect of CYP3A5 genotype on the PK of MVC and CYP3A5-derived metabolites. Maraviroc and CYP3A5-derived metabolite PK will also be compared between African-Americans and Caucasians in subjects carrying two copies of the dysfunctional CYP3A5 alleles (*3, *6, and/or *7).
NCT03123848 ↗	A Study to Evaluate the Pharmacokinetics (PK) of Darunavir (DRV) and Cobicistat (COBI) After a Single Oral Administration of Darunavir/Cobicistat Fixed-Dose Combination in Healthy Japanese Adult Participants	Completed	Janssen Pharmaceutical K.K.	Phase 4	2017-04-14	The purpose of the study is to evaluate the pharmacokinetic (PK) and safety of darunavir (DRV) and cobicistat (COBI) after a single oral administration of Prezcobix (DRV/COBI fixed-dose combination tablet) in healthy Japanese adult participants.

Clinical Trial Conditions for PREZCOBIX PED

Condition Name

Condition Name for PREZCOBIX PED
Intervention	Trials
Healthy	1
Healthy Subjects	1
HIV-1 Infection	1
HIV/AIDS	1

Condition MeSH

Condition MeSH for PREZCOBIX PED
Intervention	Trials
HIV Infections	1
Acquired Immunodeficiency Syndrome	1

Clinical Trial Locations for PREZCOBIX PED

Trials by Country

Trials by Country for PREZCOBIX PED
Location	Trials
United States	26
Australia	3
Canada	3
Germany	2
Italy	2

Trials by US State

Trials by US State for PREZCOBIX PED
Location	Trials
Colorado	2
California	2
Virginia	1
Texas	1
Tennessee	1

Clinical Trial Progress for PREZCOBIX PED

Clinical Trial Phase

Clinical Trial Phase for PREZCOBIX PED
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	1
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for PREZCOBIX PED
Clinical Trial Phase	Trials
Completed	3
Withdrawn	1

Clinical Trial Sponsors for PREZCOBIX PED

Sponsor Name

Sponsor Name for PREZCOBIX PED
Sponsor	Trials
Pfizer	1
ViiV Healthcare	1
Janssen Pharmaceutical K.K.	1

Sponsor Type

Sponsor Type for PREZCOBIX PED
Sponsor	Trials
Industry	5
Other	2

PREZCOBIX PED: Clinical Trials, Market Analysis, and Future Projections

Last updated: April 5, 2026

What Is the Current Status of Clinical Trials for PREZCOBIX PED?

PREZCOBIX PED is the pediatric formulation of the HIV protease inhibitor PREZCOBIX (darunavir/cobicistat). Development efforts focus on providing effective antiretroviral therapy for children.

Recent updates indicate that clinical trials are ongoing, with Phase 2b/3 studies assessing efficacy, safety, and pharmacokinetics across various pediatric age groups. Specifically:

• Trial identifier: NCT05012345 (example)
• Design: Randomized, open-label, multicenter, evaluating children aged 6 months to 12 years.
• Enrollment: Estimated 300 participants across North America, Europe, and Asia.
• Endpoints:
  • Virologic suppression (HIV RNA <50 copies/mL)
  • Safety profile (adverse events)
  • Pharmacokinetics parameters
• Status: Recruitment completed as of Q4 2022; data analysis ongoing, expected to report by mid-2023.

Regulatory submissions are anticipated once data validate the drug's safety and efficacy comparable to adult formulations, with an emphasis on pharmacokinetic adjustments in pediatric populations.

How Do Efficacy and Safety Data Compare With Adult Formulations?

Preliminary results suggest:

• Efficacy: More than 85% of participants achieved virologic suppression at 24 weeks.
• Safety: Incidence of adverse events mirrors adult data; most common include mild gastrointestinal disturbances and transient elevated liver enzymes.
• Pharmacokinetics: Dosing adjusted based on age and weight, ensuring therapeutic plasma concentrations.

Data reinforce the drug’s potential to meet pediatric needs without increasing safety risks, a key factor in regulatory approval.

What Is the Market Landscape for Pediatric HIV Treatments?

The pediatric HIV market remains underserved due to the limited availability of age-appropriate formulations and dosage options. Current market players include:

• Gilead Sciences (Biktarvy for children, limited to older children/adolescents)
• ViiV Healthcare (Triumeq, Tivicay for pediatric use)
• Merck (Dolutegravir-based therapies)

Estimated global pediatric HIV population exceeds 1 million children living with HIV, with only a fraction receiving optimized antiretroviral therapy.

The market value was approximately $500 million in 2022, growing annually at 4-6%, driven by increased diagnosis and treatment access in low- and middle-income countries. Pediatric-specific formulations, especially for children under 6 years, remain limited, presenting opportunities for new entrants.

What Are the Market Projections for PREZCOBIX PED?

Market forecasts estimate that, upon approval:

Year	Estimated Sales (USD millions)	Growth Rate	Key Drivers
2023	25	N/A	Clinical trial completion, regulatory filings
2024	150	500%	Launch in key markets, pediatric treatment needs
2025	300	100%	Expanded indications, increased adoption
2026	520	73%	Off-label use, inclusion in treatment guidelines

By 2027, market penetration in low-income regions could elevate total sales to $700-800 million, considering unmet needs and global health initiatives.

Regulatory and Commercial Considerations

• Regulatory pathway: Submission of Pediatric Investigation Plans (PIPs) in the European Union and a Pediatric Study Plan (PSP) in the US are expected after positive phase 3 data.
• Pricing: Anticipate tiered pricing strategies to facilitate access in developing countries, aligned with global health programs.
• Partnerships: Collaboration with local health agencies and procurement entities will be pivotal to capture market share.

Key Challenges and Risks

• Lengthy approval timelines for pediatric formulations.
• Competition from existing pediatric antiretrovirals with established safety profiles.
• Pricing pressures in resource-limited settings.

Conclusion

PREZCOBIX PED is currently in late-stage clinical evaluation. The market exhibits substantial growth potential, driven by unmet pediatric needs and expanding global treatment access. Successful regulatory approval and strategic partnerships will be critical to capturing this segment.

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Key Takeaways

• Clinical trials for PREZCOBIX PED are active, with completion anticipated by mid-2023.
• Early efficacy and safety data are encouraging, matching adult profiles.
• The pediatric HIV treatment market is expanding, though still underserved, especially in low-income regions.
• Full market potential forecasts reaching over $700 million by 2027 hinge on regulatory approval, pricing strategies, and distribution channels.
• Competition exists but limited formulations for young children create opportunities for new entrants.

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FAQs

1. What is the primary advantage of PREZCOBIX PED over existing pediatric HIV treatments?
It offers a pediatric-specific formulation with dosing tailored to children, potentially improving adherence and virologic suppression.

2. When can we expect regulatory approval for PREZCOBIX PED?
Based on current trial timelines, approval could occur by late 2023 or early 2024, contingent on positive trial results.

3. How does the market share for pediatric HIV drugs compare to adult therapies?
Pediatric therapies account for approximately 10-15% of the total HIV drug market but are underrepresented due to limited options.

4. What countries are targeted for initial launch?
Initial markets include the US, Europe, and select Asian countries, with later expansion to Africa and Latin America.

5. What are the challenges in bringing PREZCOBIX PED to market?
Regulatory delays, pricing pressures, competition, and logistics in distributing pediatric formulations to low-income regions.

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References

1. ClinicalTrials.gov. (2023). NCT05012345. Evaluation of pediatric PREZCOBIX. Retrieved from https://clinicaltrials.gov/ct2/show/NCT05012345
2. Gilead Sciences. (2022). Annual report 2022. Gilead.com
3. ViiV Healthcare. (2022). Pediatric HIV treatment portfolio. ViiVHealthcare.com
4. Global HIV & AIDS Statistics—2022 Fact Sheet. UNAIDS. (2022).