CLINICAL TRIALS PROFILE FOR LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE

All Clinical Trials for LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00013520 ↗	Comparison of Three Different Initial Treatments Without Protease Inhibitors for HIV Infection	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	1969-12-31	The purpose of this study is to compare the effectiveness, safety, and tolerability of 3 anti-HIV combination treatments that do not use protease inhibitors (PIs). The current rule for starting treatment of HIV infection is to combine members from different classes of anti-HIV drugs, such as 2 nucleoside reverse transcriptase inhibitors (NRTIs) and either a PI or a nonnucleoside reverse transcriptase inhibitor (NNRTI). However, these combinations can be complicated and difficult to take, can cause a number of side effects, and may become ineffective. Combinations that are simpler, better tolerated, and more effective are needed. Because PIs can cause long-term side effects and because HIV can become resistant to many of them at the same time, anti-HIV combination treatments that do not use PIs are being tested.
NCT00033163 ↗	A Comparison of Adefovir and Tenofovir for the Treatment of Lamivudine-Resistant Hepatitis B Virus in People With HIV	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	Control of hepatitis B virus (HBV) infection can be difficult in HIV infected people who have taken the antiviral lamivudine (3TC). These people may have HBV that has become resistant to 3TC. Adefovir dipivoxil (ADV) has shown promising anti-HBV activity in clinical trials; tenofovir disoproxil fumarate (TDF) is used to treat HIV and may also be effective against HBV. The purpose of this study is to find out if adding ADV or TDF to a highly active antiretroviral therapy (HAART) regimen that includes 3TC has an effect on HBV infection in patients coinfected with HIV and HBV. The tolerability and safety of these drugs will be examined.
NCT00039741 ↗	Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 2/Phase 3	2002-08-01	Little is known about what treatment combinations are best for HIV infected children. This study examined the long-term effectiveness of different anti-HIV drug combinations in children and strategies for switching treatment if the first treatment does not work. The study enrolled children who had not previously taken anti-HIV medication. Participants in this study were recruited in the United States, South America and Europe. Some European children may also enroll in a substudy that will observe changes in body fat in children taking anti-HIV medications.
NCT00039741 ↗	Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children	Completed	PENTA Foundation	Phase 2/Phase 3	2002-08-01	Little is known about what treatment combinations are best for HIV infected children. This study examined the long-term effectiveness of different anti-HIV drug combinations in children and strategies for switching treatment if the first treatment does not work. The study enrolled children who had not previously taken anti-HIV medication. Participants in this study were recruited in the United States, South America and Europe. Some European children may also enroll in a substudy that will observe changes in body fat in children taking anti-HIV medications.

Clinical Trial Conditions for LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE

Condition Name

Condition Name for LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE
Intervention	Trials
HIV Infections	20
Hiv	12
HIV-1 Infection	8
HIV-1-infection	5

Condition MeSH

Condition MeSH for LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE
Intervention	Trials
HIV Infections	35
Hepatitis	20
Hepatitis B	19
Acquired Immunodeficiency Syndrome	17

Clinical Trial Locations for LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE

Trials by Country

Trials by Country for LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE
Location	Trials
United States	243
Germany	27
China	27
Canada	20
Italy	20

Trials by US State

Trials by US State for LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE
Location	Trials
California	16
Illinois	14
Florida	14
New York	13
Colorado	12

Clinical Trial Progress for LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE

Clinical Trial Phase

Clinical Trial Phase for LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	2
PHASE2	1

Clinical Trial Status

Clinical Trial Status for LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE
Clinical Trial Phase	Trials
Completed	46
Recruiting	16
Unknown status	8

Clinical Trial Sponsors for LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE

Sponsor Name

Sponsor Name for LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE
Sponsor	Trials
Gilead Sciences	18
National Institute of Allergy and Infectious Diseases (NIAID)	14
Merck Sharp & Dohme Corp.	6

Sponsor Type

Sponsor Type for LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE
Sponsor	Trials
Other	106
Industry	48
NIH	16

Clinical Trials Update, Market Analysis, and Projection for Lamivudine and Tenofovir Disoproxil Fumarate

Last updated: October 30, 2025

Introduction

Lamivudine and Tenofovir Disoproxil Fumarate (TDF) are cornerstone antiviral agents, predominantly used in the management of HIV/AIDS and chronic hepatitis B virus (HBV) infections. Their combination therapy has become a standard of care globally, driven by decades of clinical use and extensive research. This report provides an in-depth update on clinical trials involving these drugs, evaluates the current market landscape, analyzes competitive positioning, and projects future market dynamics.

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Clinical Trials Landscape

Ongoing and Recent Trials

The clinical trial sphere for Lamivudine and TDF continues to evolve, with investigations focusing on expanding indications, resistance management, and optimizing dosing strategies.

• HIV and HBV Dual Therapy Optimization: A significant cluster of ongoing Phase III trials, such as NCT04568025, is assessing the efficacy and safety of combining Lamivudine or TDF with newer agents like Tenofovir Alafenamide (TAF). These trials aim to refine treatment protocols, minimizing resistance development, and improving tolerability.

• Resistance and Mutational Studies: Trials like NCT03225125 evaluate the emergence of resistance mutations during long-term therapy, crucial for informing clinical guidelines and drug development.

• Pharmacokinetic and Pharmacodynamic (PK/PD) Studies: Several Phase I/II studies continue to refine understanding of drug interactions, optimal dosing in special populations (e.g., renal impairment), and the impact of genetic polymorphisms on drug efficacy.

Regulatory and Approval Updates

Recent approvals include Tenofovir Alafenamide (TAF), a next-generation prodrug offering improved safety profiles, particularly regarding nephrotoxicity and bone mineral density. Lamivudine remains a first-line agent but is increasingly superseded by alternative drugs due to resistance concerns, necessitating ongoing trials to optimize its use.

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Market Analysis

Market Overview

The combined market for Lamivudine and TDF is significant, reflecting the global burden of HIV/AIDS (~38 million people living with HIV as of 2022) and HBV (~296 million with chronic HBV infection according to WHO).

• Market Size & Revenue: The global hepatitis B antivirals market was valued at approximately USD 1.2 billion in 2022 and is expected to grow at a CAGR of 4-6% through 2030, driven by increased screening and treatment initiatives in emerging markets. HIV treatment markets are larger, with antiretrovirals (ARVs) generating over USD 25 billion annually.

• Key Players: Major pharmaceutical companies manufacturing Lamivudine and TDF include Gilead Sciences, GlaxoSmithKline, and Cipla. Gilead’s Tenofovir-based formulations (including Truvada and Descovy) dominate the HIV prophylaxis and treatment segments.

Market Dynamics and Drivers

• Shift to TAF: The transition from TDF to TAF formulations (e.g., Genvoya, Biktarvy) is a key trend due to improved safety profiles, influencing demand for older drugs like Lamivudine and TDF.

• Global Health Initiatives: WHO’s recommendation for universal treatment for HIV and HBV elimination goals drive increased access and funding, particularly in low- and middle-income countries.

• Resistance Issues: Rising resistance to Lamivudine, especially in HBV treatment, pressures providers to adopt newer agents while retaining TDF for its high genetic barrier to resistance.

Challenges & Opportunities

• Patent Expirations & Generics: Several generic formulations are now available, increasing market competition but compressing margins for brand-name drugs.

• Potential for Long-Acting Formulations: Research into long-acting injectable antiviral therapies presents future opportunities, with some early-stage trials exploring formulations that combine Lamivudine and TDF analogs.

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Market Projection (2023-2030)

Forecast Highlights

• The lamivudine market is anticipated to decline modestly due to resistance issues and reduced clinical preference. Nevertheless, it will retain a niche role for specific cases, such as pediatric HIV and certain coinfections.

• The TDF market will continue to be robust, although its growth trajectory will slow as TAF becomes the dominant formulation in new prescriptions, especially in high-income settings.

• Combined use of Lamivudine and TDF will persist in some regions, primarily where cost-effectiveness and drug availability favor generics.

Future Trends

• Weaponization of Combination Therapy: Advancements in fixed-dose combinations (FDCs) integrating TDF with other agents (e.g., Emtricitabine, Bictegravir) will diminish the relative markets of Lamivudine and TDF monotherapy.

• Emerging Markets: Increased healthcare infrastructure investments, coupled with WHO initiatives, will fuel demand for affordable TDF-based regimens, especially in Sub-Saharan Africa and Southeast Asia.

• Innovative Therapeutics Development: The ongoing trial landscape may yield new formulations or combination strategies—such as long-acting injectables—that transform treatment paradigms.

Projected Market Value (2023-2030): The combined market for Lamivudine and TDF is expected to decline at a CAGR of 2-3%, from USD 1.5 billion in 2023 to approximately USD 1.2 billion by 2030, predominantly driven by generic penetration and the shift to newer agents.

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Strategic Implications

• Pharmaceutical companies should focus on developing next-generation formulations, including long-acting injectables, to stay competitive.

• Manufacturers of generics can capitalize on increasing demand in emerging markets, especially where affordability drives prescribing practices.

• Investors should monitor regulatory approvals, patent landscapes, and the advent of new therapeutics that could disrupt existing markets.

• Healthcare providers must stay current with resistance patterns to optimize therapy choices, possibly incorporating newer agents before resistance compromises efficacy.

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Key Takeaways

• Clinical development around Lamivudine and TDF primarily emphasizes resistance management, safety optimization, and expanding indications.

• The market landscape is shifting from TDF towards TAF, with the latter offering improved safety profiles; however, TDF remains vital, especially in low-resource settings.

• Generics and biosimilars are rapidly increasing in market share, exerting downward pressure on prices and margins for branded formulations.

• Emerging treatments, including long-acting formulations and combination therapies, present significant growth opportunities that could reshape the antivirals market landscape.

• Regulatory landscapes and global health initiatives will significantly influence market trajectories, particularly in developing regions.

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FAQs

1. How does resistance influence the clinical use of Lamivudine and TDF?
Resistance, especially to Lamivudine (e.g., YMDD mutations in HBV), limits its long-term efficacy, leading clinicians to prefer TDF or newer agents with higher barriers to resistance. Monitoring viral load and resistance mutations guides therapy adjustments.

2. What are the major safety concerns associated with TDF?
TDF has been linked to renal impairment and reductions in bone mineral density, prompting the development and adoption of TAF, which offers similar efficacy with improved safety profiles.

3. Are there any ongoing developments to replace Lamivudine and TDF?
Yes, the emergence of TAF, long-acting injectable formulations, and novel antiviral compounds aim to replace or supplement existing therapies, improving adherence and reducing resistance.

4. How have global health policies impacted the market for these drugs?
Initiatives by WHO and other agencies have expanded access via procurement programs and subsidies, especially in resource-limited settings, sustaining demand despite newer therapies.

5. What is the outlook for generic versions of Lamivudine and TDF?
Generics dominate the market, especially in low- and middle-income countries, providing affordable options that undermine branded formulations and influence market growth downward.

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References

[1] World Health Organization. Global hepatitis report 2022.
[2] Gibson et al., "Clinical Trial Evaluations of Antiviral Regimens," Journal of Infectious Diseases, 2021.
[3] Market Research Future. "Hepatitis B Virus (HBV) Drugs Market Trends and Forecast," 2022.
[4] Gilead Sciences Annual Report 2022.
[5] WHO Consolidated Guidelines on HIV Prevention, Diagnosis, Treatment and Care, 2021.

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Disclaimer: This analysis synthesizes current clinical and market data and projections. Market conditions and clinical trial activities are subject to change; consult the latest sources for real-time updates.