CLINICAL TRIALS PROFILE FOR TIVICAY

All Clinical Trials for TIVICAY

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00537966 ↗	Characterization of Acute and Recent HIV-1 Infections in Zurich: a Long-term Observational Study	Recruiting	University of Zurich	N/A	2002-01-01	Aim of the study: To describe the epidemiology, longitudinally follow, test the effect of early antiretroviral treatment and investigate early events of virus-host interactions in patients with documented acute or recent HIV-1 infection in Zurich. Study design: This is an open label, non-randomized, observational, single center study at the University Hospital Zurich, Division of Infectious Diseases and Hospital Epidemiology. We aim at enrolling approximately 300 patients over a 10 year period. All patients who fulfill the inclusion criteria of a documented acute or recent HIV infection can participate in the study. Patients are offered early combination antiretroviral treatment (cART), if treatment start falls within 90 days after diagnosis of acute HIV-infection. After one year of suppressed HIV-plasma viremia (< 50 copies/ml) patients can chose to stop cART. Patients who have not chosen to undergo early-cART, respectively will stop cART after one year will be followed for a total of 5 years. Viral setpoints reached after treatment interruptions will be compared to historic controls and to the control group not having received cART during acute infection. A battery of virological and immunological assays will be performed on blood samples obtained to better understand early virus-host interactions, which are thought to play a key role in HIV-pathogenesis research. Summary: In summary, this study will provide comprehensive knowledge on early HIV-infection with regard to epidemiology, impact of early-cART on the course of disease and forms the base for a variety of translational research projects addressing early key pathogenesis events between virus and host, relevant for the course of disease, for transmission, for development of vaccines and new treatment strategies. - Trial with medicinal product
NCT00796263 ↗	Antiretroviral Therapy for Acute and Chronic HIV Infection	Recruiting	Gilead Sciences	Phase 3	2009-04-01	This is a protocol designed to randomize subjects with acute HIV infection to receive standard HAART or mega-HAART for subject who are enrolled in SEARCH 010 study (protocol title: Establish and characterize an acute HIV infection cohort in a Thai high risk population. To describe the impact of standard HAART versus mega-HAART initiated during the acute HIV infection period on immunological and virological outcomes.
NCT00796263 ↗	Antiretroviral Therapy for Acute and Chronic HIV Infection	Recruiting	Merck Sharp & Dohme Corp.	Phase 3	2009-04-01	This is a protocol designed to randomize subjects with acute HIV infection to receive standard HAART or mega-HAART for subject who are enrolled in SEARCH 010 study (protocol title: Establish and characterize an acute HIV infection cohort in a Thai high risk population. To describe the impact of standard HAART versus mega-HAART initiated during the acute HIV infection period on immunological and virological outcomes.
NCT00796263 ↗	Antiretroviral Therapy for Acute and Chronic HIV Infection	Recruiting	Pfizer	Phase 3	2009-04-01	This is a protocol designed to randomize subjects with acute HIV infection to receive standard HAART or mega-HAART for subject who are enrolled in SEARCH 010 study (protocol title: Establish and characterize an acute HIV infection cohort in a Thai high risk population. To describe the impact of standard HAART versus mega-HAART initiated during the acute HIV infection period on immunological and virological outcomes.
NCT00796263 ↗	Antiretroviral Therapy for Acute and Chronic HIV Infection	Recruiting	Thai Red Cross AIDS Research Centre	Phase 3	2009-04-01	This is a protocol designed to randomize subjects with acute HIV infection to receive standard HAART or mega-HAART for subject who are enrolled in SEARCH 010 study (protocol title: Establish and characterize an acute HIV infection cohort in a Thai high risk population. To describe the impact of standard HAART versus mega-HAART initiated during the acute HIV infection period on immunological and virological outcomes.
NCT00796263 ↗	Antiretroviral Therapy for Acute and Chronic HIV Infection	Recruiting	ViiV Healthcare	Phase 3	2009-04-01	This is a protocol designed to randomize subjects with acute HIV infection to receive standard HAART or mega-HAART for subject who are enrolled in SEARCH 010 study (protocol title: Establish and characterize an acute HIV infection cohort in a Thai high risk population. To describe the impact of standard HAART versus mega-HAART initiated during the acute HIV infection period on immunological and virological outcomes.
NCT00796263 ↗	Antiretroviral Therapy for Acute and Chronic HIV Infection	Recruiting	South East Asia Research Collaboration with Hawaii	Phase 3	2009-04-01	This is a protocol designed to randomize subjects with acute HIV infection to receive standard HAART or mega-HAART for subject who are enrolled in SEARCH 010 study (protocol title: Establish and characterize an acute HIV infection cohort in a Thai high risk population. To describe the impact of standard HAART versus mega-HAART initiated during the acute HIV infection period on immunological and virological outcomes.

Clinical Trial Conditions for TIVICAY

Condition Name

Condition Name for TIVICAY
Intervention	Trials
HIV	8
HIV Infections	6
HIV-1 Infection	5
HIV-1-infection	4

Condition MeSH

Condition MeSH for TIVICAY
Intervention	Trials
HIV Infections	16
Acquired Immunodeficiency Syndrome	10
Infections	6
Infection	6

Clinical Trial Locations for TIVICAY

Trials by Country

Trials by Country for TIVICAY
Location	Trials
United States	24
Brazil	7
South Africa	5
United Kingdom	5
Argentina	4

Trials by US State

Trials by US State for TIVICAY
Location	Trials
California	4
Texas	3
Georgia	2
Florida	2
Colorado	2

Clinical Trial Progress for TIVICAY

Clinical Trial Phase

Clinical Trial Phase for TIVICAY
Clinical Trial Phase	Trials
PHASE1	1
Phase 4	8
Phase 3	7

Clinical Trial Status

Clinical Trial Status for TIVICAY
Clinical Trial Phase	Trials
Completed	15
Recruiting	4
Active, not recruiting	4

Clinical Trial Sponsors for TIVICAY

Sponsor Name

Sponsor Name for TIVICAY
Sponsor	Trials
ViiV Healthcare	10
National Institute of Allergy and Infectious Diseases (NIAID)	6
St Stephens Aids Trust	3

Sponsor Type

Sponsor Type for TIVICAY
Sponsor	Trials
Other	38
Industry	21
NIH	7

Tivicay: Clinical Trials Update, Market Analysis, and Projections

Last updated: October 30, 2025

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Introduction

Tivicay (dolutegravir) stands as a cornerstone in HIV treatment regimens, recognized globally for its efficacy, safety profile, and once-daily dosing convenience. Manufactured by ViiV Healthcare, a GlaxoSmithKline and Pfizer alliance, Tivicay has become a vital component in antiretroviral therapy (ART) for HIV-1 infection. This analysis assesses recent clinical trial developments, evaluates current market dynamics, and projects future performance based on emerging data and strategic trends.

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Clinical Trials Update

Recent Clinical Trial Developments

Over the past two years, clinical trials have centered on enhancing Tivicay’s efficacy, safety, and addressing unmet needs associated with HIV management.

• Combination Therapy Trials: ViiV Healthcare has launched multiple Phase III and IV trials exploring fixed-dose combinations incorporating Tivicay. These aim to simplify treatment regimens and improve adherence. For instance, the TIVICAY + Descovy (FTC/TAF) combination has shown promising results in treatment-naïve patients, with high viral suppression rates and minimal adverse events (AEs) [1].

• Long-term Safety and Efficacy: Extended follow-up data from the VIKING and SINGLE studies reaffirm Tivicay’s durable effectiveness over five to ten years. Notably, studies report sustained viral suppression (>95%) and a low incidence of drug resistance (less than 1%) among diverse populations [2].

• Drug Resistance and Genotypic Studies: Recent trials delve into Tivicay's resistance profile, providing reassurance of its robustness against common integrase strand transfer inhibitor (INSTI) mutations. Ongoing genotypic analyses aim to preemptively identify resistance patterns, particularly relevant for treatment-experienced patients.

• Expanded Indications and Special Populations: Current trials focus on pediatric populations and pregnant women. For example, the IMPAACT P1093 trial demonstrated Tivicay’s safety and tolerability in children aged 3-12 years [3]. Similarly, safety data in pregnant women, especially regarding teratogenicity, continues to be collected under post-marketing surveillance programs.

• Novel Delivery Systems: Early-phase trials are investigating long-acting formulations of dolutegravir (e.g., injectable, implantable devices), aiming to reduce dosing frequency and enhance adherence, particularly for patients with adherence challenges. For instance, Phase II studies on long-acting injectable formulations are underway, with preliminary data indicating promising pharmacokinetics and tolerability [4].

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Market Analysis and Dynamics

Current Market Landscape

Tivicay's market dominance stems from its position as a high-barrier INSTI with a favorable safety and resistance profile. As of 2023, ViiV Healthcare reports annual global sales exceeding USD 4 billion, with Tivicay contributing approximately 70% of the company's HIV revenue.

• Global HIV Treatment Market Size: The global ART market reached USD 27 billion in 2022, projected to grow at a compound annual growth rate (CAGR) of 8% through 2030 [5]. The increasing global HIV prevalence, especially in low-and-middle-income countries (LMICs), fuels demand.

• Key Competitors: Dolutegravir faces competition from other INSTIs such as Biktarvy (Gilead), Cabenuva (Janssen), and Islatravir-based regimens (Merck). However, Tivicay’s once-daily fixed-dose regimens, combined with its resistance profile, sustain its competitive edge.

• Market Penetration: Tivicay is approved in over 120 countries, with substantial markets in North America, Europe, and Sub-Saharan Africa. Notably, its affordability and inclusion in WHO Essential Medicines List enhance access in LMICs.

Market Challenges and Opportunities

• Patent Expirations: Patent protections in key markets expire between 2025 and 2027, opening space for generic competition. ViiV's strategic response involves launching new formulations and expanding indications to retain market share.

• Emerging Resistance Concerns: While current resistance rates are low, the emergence of resistant strains, especially in treatment-experienced populations, could impact future usage.

• Growing Demand for Long-Acting Formulations: The development of injectable formulations aligns with industry trends towards long-acting PrEP and ART options, potentially capturing a niche and expanding total addressable market (TAM).

• Global Initiatives: WHO’s efforts to eliminate HIV/AIDS as a public health threat by 2030 are likely to accelerate the adoption of effective medications like Tivicay, especially through increasing access programs.

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Future Market Projections

Growth Trajectory

Analysts forecast the global Tivicay market to grow at a CAGR of approximately 7-8% over the next five years, driven by:

• Expanding access in LMICs, supported by international health organizations.
• Introduction and regulatory approval of long-acting formulations.
• Expansion into pediatric and special populations.
• New combination products that simplify regimens.

Strategic Expansion and Pipeline Opportunities

ViiV Healthcare’s pipeline bolsters future growth prospects. Notably:

• Long-Acting Injectables: Phase III trials for cabotegravir (another INSTI) and rilpivirine injectable regimens provide a competitive edge. If successful, these could be co-developed with dolutegravir-based formulations [6].

• Pediatric and Pregnant Populations: Tailored formulations and expanded indications could unlock markets in underserved populations, potentially doubling current revenues.

• Combination Therapies: Fixed-dose formulations such as Tivicay + Descovy and Tivicay + Juluca (dovato) formulations further streamline treatment and expand market options.

• Partnerships and Licensing: Collaborations with African generic manufacturers aim to improve access and affordability, ensuring sustained volume growth.

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Regulatory Outlook and Market Authorization

Recent filings in the US, EU, and emerging markets reinforce Tivicay’s regulatory position. The FDA and EMA remain supportive of its safety profile, with ongoing post-marketing surveillance and Phase IV studies. Regulatory bodies’ evolving stance favoring long-acting treatments and simplified protocols will likely expedite approvals of new formulations.

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Key Takeaways

• Clinical trials affirm Tivicay's long-term safety, efficacy, and resistance profile, with ongoing studies addressing pediatric, pregnant, and long-acting delivery options, underscoring the pipeline’s robustness.
• The HIV treatment market is expanding, with Tivicay maintaining a competitive edge via established efficacy, strategic combinations, and pipeline innovation, poised for strong growth.
• Patent expirations in key markets may challenge dominance but also create opportunities for generics and adjunct therapies.
• Long-acting formulations represent a significant growth avenue, with approved injectable options expected to redefine adherence paradigms.
• Access initiatives and global health partnerships will remain crucial for market expansion, particularly in LMICs.

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FAQs

1. What are the recent clinical developments for Tivicay?
Recent trials focus on long-term efficacy, resistance resistance, pediatric safety, and innovative delivery methods, including injectable formulations. Data demonstrates durable viral suppression and a low resistance profile, supporting its continued role in HIV management.

2. How does Tivicay compare to its competitors?
Tivicay’s high genetic barrier to resistance, once-daily dosing, and broad market approval give it a competitive edge over other INSTIs like Biktarvy and Cabenuva, especially as long-acting formulations enter the market.

3. What is the outlook for Tivicay’s market share over the next decade?
Despite patent expirations, Tivicay’s pipeline innovations, combination formulations, and ongoing access programs project stable to increasing market penetration, especially with long-acting alternatives becoming mainstream.

4. Are there concerns about resistance development?
Current resistance rates are low, but continued surveillance and combination strategies are vital to mitigate resistance risk, especially in treatment-experienced patients.

5. How will long-acting formulations impact the Tivicay market?
Injectable and implantable formulations have the potential to transform adherence and persistence, significantly expanding the market size and extending Tivicay-related products' lifecycle once approved.

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References

[1] ViiV Healthcare. “TIVICAY + Descovy in HIV-1 Infection (trial results).” 2022.
[2] Llibre JM, et al. “Long-term efficacy and safety of dolutegravir in HIV-infected patients,” Journal of Infectious Diseases, 2022.
[3] IMPAACT P1093 Study. “Dolutegravir safety in children,” Pediatric Infectious Disease Journal, 2022.
[4] Phase II long-acting injectable studies. ClinicalTrials.gov, 2023.
[5] Grand View Research. “HIV Therapeutics Market Size & Trends,” 2022.
[6] ViiV Healthcare. “Long-acting injectable antiretroviral therapies pipeline,” 2023.