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Last Updated: March 20, 2025

CLINICAL TRIALS PROFILE FOR TRIZIVIR


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All Clinical Trials for Trizivir

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00004981 ↗ Safety and Effectiveness of Three Anti-HIV Drugs Combined in One Pill (Trizivir) Unknown status Glaxo Wellcome Phase 3 1969-12-31 The purpose of this study is to look at the safety and effectiveness of a pill called Trizivir that is a combination of three anti-HIV drugs (zidovudine, lamivudine, and abacavir). Zidovudine and lamivudine are often given combined in one pill (Combivir). In this study, Trizivir will be compared to Combivir plus abacavir.
NCT00011895 ↗ Safety and Effectiveness of TRIZIVIR (Abacavir/Lamivudine/Zidovudine) With Efavirenz in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs Unknown status GlaxoSmithKline Phase 4 2001-02-01 The purpose of this study is to determine the effect of treatment with Trizivir (TZV) plus efavirenz (EFV) or TZV alone on viral load (level of HIV in the blood).
NCT00038506 ↗ Study Of Investigational Regimen Combining FDA Approved HIV Drugs In HIV Subjects Experiencing Early Virologic Failure Completed ViiV Healthcare Phase 4 2002-03-01 This study is a 48-week study to evaluate the efficacy and safety of an investigational regimen combining FDA approved HIV drugs in antiretroviral-experienced subjects failing on their first highly active antiretroviral therapy regimen.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Trizivir

Condition Name

Condition Name for Trizivir
Intervention Trials
HIV Infections 12
HIV Infection 4
HIV 3
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Condition MeSH

Condition MeSH for Trizivir
Intervention Trials
HIV Infections 16
Acquired Immunodeficiency Syndrome 5
Infections 5
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Clinical Trial Locations for Trizivir

Trials by Country

Trials by Country for Trizivir
Location Trials
United States 105
Spain 8
Mexico 6
Canada 5
France 3
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Trials by US State

Trials by US State for Trizivir
Location Trials
New York 8
California 7
Georgia 6
Florida 6
Texas 5
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Clinical Trial Progress for Trizivir

Clinical Trial Phase

Clinical Trial Phase for Trizivir
Clinical Trial Phase Trials
Phase 4 11
Phase 3 5
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Trizivir
Clinical Trial Phase Trials
Completed 16
Unknown status 2
Terminated 2
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Clinical Trial Sponsors for Trizivir

Sponsor Name

Sponsor Name for Trizivir
Sponsor Trials
GlaxoSmithKline 7
National Institute of Allergy and Infectious Diseases (NIAID) 3
Gilead Sciences 2
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Sponsor Type

Sponsor Type for Trizivir
Sponsor Trials
Other 22
Industry 14
NIH 5
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TRIZIVIR: Clinical Trials, Market Analysis, and Projections

Introduction

TRIZIVIR is a fixed-dose combination antiretroviral medication containing abacavir, lamivudine, and zidovudine, all of which are nucleoside reverse transcriptase inhibitors (NRTIs). This article provides an update on the clinical trials, market analysis, and projections for TRIZIVIR.

Clinical Trials and Efficacy

TRIZIVIR's efficacy is primarily based on studies conducted during the development of its individual components. No specific clinical studies were carried out to assess the safety and effectiveness of the combined tablet. However, the combination of abacavir, lamivudine, and zidovudine was shown to be at least as effective as comparator combinations in keeping viral loads low in treatment-naive and moderately antiretroviral-experienced patients[1][4].

Safety and Side Effects

Clinical trials have highlighted several side effects associated with TRIZIVIR, including headache and nausea, which may affect more than 1 in 10 people. Serious and sometimes fatal hypersensitivity reactions have also been reported with abacavir, a component of TRIZIVIR. Additionally, severe acute exacerbations of hepatitis B have been reported in patients co-infected with hepatitis B virus (HBV) and HIV-1 who discontinued lamivudine[1][4].

Market Analysis

Current Market Dynamics

The HIV-1 treatment market is dominated by combination therapies, with Gilead Sciences holding a significant market share. However, TRIZIVIR, which combines three NRTIs, has seen its market position challenged by newer, more effective therapies.

Market Share and Competition

Gilead Sciences, with its blockbuster drugs like Biktarvy, Genvoya, and Odefsey, dominates the HIV-1 market. ViiV Healthcare is the second major player, but the market is shifting towards single-tablet regimens (STRs) and away from multiple-tablet regimens (MTRs) like TRIZIVIR. The US market for MTRs has declined significantly, from USD 5,918 million in 2018 to USD 3,867 million in 2020, while the market for STRs has increased from USD 10,305 million in 2018 to USD 13,620 million in 2020[2].

Shift to Newer Therapies

The market is increasingly favoring newer therapies such as Biktarvy, which has shown excellent safety and efficacy and does not require pharmacokinetic boosting. Biktarvy's market size has grown significantly since its launch in 2018, from USD 1,144 million to USD 6,095 million in 2020, and is expected to reach USD 10,673 million by 2024[2].

Projections and Future Outlook

Declining Market Share

Given the trend towards newer and more effective therapies, TRIZIVIR's market share is expected to decline further. The preference for STRs over MTRs, combined with the launch of new therapies like Lenacapavir and Islatravir, will likely reduce the demand for TRIZIVIR[2][5].

Patent Expiry and Market Impact

Several key HIV-1 therapies, including some from Gilead Sciences and ViiV Healthcare, are facing patent expiry in the coming years. This could lead to increased competition from generic versions, further impacting TRIZIVIR's market position. For example, patents for Truvada, Atripla, and Descovy are set to expire in the US between 2021 and 2025[2].

Clinical Trials Landscape

Global HIV Clinical Trials Market

The global HIV clinical trials market is expected to grow at a CAGR of 5.8% from 2025 to 2030, driven by increasing drug approvals, rising R&D investment, and growing incidence of HIV. North America, particularly the US, dominates this market due to the high number of clinical trials and government support[3].

Emerging Therapies

Clinical trials are ongoing for new and innovative therapies, such as Lenacapavir and Islatravir, which are expected to dominate the market for HIV prophylaxis and treatment. These therapies offer improved safety, efficacy, and patient compliance, which will further marginalize older regimens like TRIZIVIR[3][5].

Key Takeaways

  • Efficacy and Safety: TRIZIVIR is effective in reducing viral loads but has significant side effects and is less favored compared to newer therapies.
  • Market Dynamics: The HIV-1 treatment market is shifting towards single-tablet regimens and newer therapies, reducing the demand for TRIZIVIR.
  • Projections: TRIZIVIR's market share is expected to decline due to patent expiries and the launch of more effective therapies.
  • Clinical Trials: The global HIV clinical trials market is growing, with a focus on innovative and long-acting therapies.

FAQs

What are the active ingredients in TRIZIVIR?

TRIZIVIR contains abacavir, lamivudine, and zidovudine, all of which are nucleoside reverse transcriptase inhibitors (NRTIs)[1].

What are the common side effects of TRIZIVIR?

Common side effects include headache and nausea, affecting more than 1 in 10 people. Serious hypersensitivity reactions and severe acute exacerbations of hepatitis B can also occur[1][4].

Why is TRIZIVIR less preferred in the current market?

TRIZIVIR is less preferred due to the shift towards single-tablet regimens (STRs) and newer therapies that offer better safety, efficacy, and patient compliance[2].

What are the emerging therapies in the HIV-1 treatment market?

Emerging therapies include Lenacapavir, Islatravir, and Vocabria (Cabotegravir LA), which are expected to dominate the market for HIV prophylaxis and treatment[5].

How is the global HIV clinical trials market expected to grow?

The global HIV clinical trials market is projected to grow at a CAGR of 5.8% from 2025 to 2030, driven by increasing drug approvals and R&D investment[3].

Sources

  1. European Medicines Agency (EMA). Trizivir | European Medicines Agency (EMA).
  2. DelveInsight. Changing Dynamics of HIV-1 Treatment Market - DelveInsight.
  3. Grand View Research. HIV Clinical Trials Market Size, Share | Industry Report, 2030.
  4. FDA. TRIZIVIR (abacavir, lamivudine, and zidovudine tablets), for oral use.
  5. DelveInsight. Top Drugs To Watch in HIV (2025) - DelveInsight.

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