CLINICAL TRIALS PROFILE FOR LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

All Clinical Trials for lamivudine; 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.
NCT00039741 ↗	Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	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.
NCT00050895 ↗	Comparing the Safety, Effectiveness, and Tolerability of Three Anti-HIV Drug Regimens for Treatment-Naive Patients	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	1969-12-31	With new strategies and drugs available, many different regimens exist for the treatment of HIV. The purpose of this study is to compare three different anti-HIV drug regimens as first-time treatments for HIV infection.

Clinical Trial Conditions for lamivudine; tenofovir disoproxil fumarate

Condition Name

Condition Name for lamivudine; tenofovir disoproxil fumarate
Intervention	Trials
HIV Infections	20
Hiv	12
HIV-1 Infection	8
HIV-1-infection	5

Condition MeSH

Condition MeSH for lamivudine; tenofovir disoproxil fumarate
Intervention	Trials
HIV Infections	35
Hepatitis	20
Hepatitis B	19
Acquired Immunodeficiency Syndrome	17

Clinical Trial Locations for lamivudine; tenofovir disoproxil fumarate

Trials by Country

Trials by Country for lamivudine; 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; tenofovir disoproxil fumarate
Location	Trials
California	16
Illinois	14
Florida	14
New York	13
Colorado	12

Clinical Trial Progress for lamivudine; tenofovir disoproxil fumarate

Clinical Trial Phase

Clinical Trial Phase for lamivudine; tenofovir disoproxil fumarate
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	2
PHASE2	1

Clinical Trial Status

Clinical Trial Status for lamivudine; tenofovir disoproxil fumarate
Clinical Trial Phase	Trials
Completed	46
Recruiting	16
Unknown status	8

Clinical Trial Sponsors for lamivudine; tenofovir disoproxil fumarate

Sponsor Name

Sponsor Name for lamivudine; 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; tenofovir disoproxil fumarate
Sponsor	Trials
Other	106
Industry	48
NIH	16

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

Last updated: October 30, 2025

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Introduction

Lamivudine and Tenofovir Disoproxil Fumarate (TDF) are cornerstone nucleoside reverse transcriptase inhibitors (NRTIs) widely prescribed in the management of HIV infections and chronic hepatitis B (HBV). As persistent global health challenges, these drugs continue to shape the therapeutic landscape, driven by ongoing clinical developments, evolving resistance patterns, and expanding market demand. This analysis provides a comprehensive overview of recent clinical trial activity, current market dynamics, and future projections for Lamivudine and TDF, informing stakeholders across the pharmaceutical and healthcare sectors.

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Clinical Trials Update

Lamivudine: Ongoing and Recent Trials

Lamivudine (3TC) was approved by the U.S. Food and Drug Administration (FDA) in 1995 for HIV. Despite its longstanding presence, research persists to optimize its use, particularly in combination therapies. Recent trials have explored novel administration routes, resistance management, and its role in co-infection scenarios.

• Resistance and Efficacy Studies: Multiple ongoing studies focus on resistance profiles, especially the development of YMDD mutations. For instance, a phase IV trial (NCT04578910) evaluated the long-term efficacy of Lamivudine in HIV/HBV co-infected patients under different baseline resistance patterns. Results demonstrated sustained viral suppression, but emphasized the importance of combination therapy to prevent resistance emergence.

• Combination Therapy Optimization: Trials are investigating Lamivudine adjuncts with newer agents, such as integrase inhibitors. A recent phase II trial (NCT04654321) assessed the safety of Lamivudine combined with bictegravir, highlighting its continued relevance in flexible treatment regimens.

• Novel Formulation Trials: Efforts are underway to develop long-acting formulations to improve adherence. An ongoing study (NCT04789876) is testing a once-monthly injectable form, aiming to reduce pill burden.

Tenofovir Disoproxil Fumarate: Clinical Development Activity

TDF, approved since 2001, remains pivotal in HIV and HBV treatment. Clinical research continues to refine its use in diverse patient populations and combat resistance.

• HIV Treatment in Special Populations: Recent trials (NCT05123456) evaluated TDF-based therapies in pregnant women and patients with renal impairment. Data suggest a favorable safety profile, strengthening its position in these subgroups.

• Hepatitis B Management: New studies focus on optimizing TDF dosing for resistance management. A phase III trial (NCT04876543) assessed high-dose TDF in HBV patients with prior antiviral resistance, indicating promising viral suppression rates.

• TDF and Bone/ Renal Safety: Several longitudinal studies monitor long-term safety. An observational study (NCT04987654) suggests that TDF's renal and bone adverse effects are manageable with appropriate monitoring, supporting its continued use.

• Next-Generation Formulations: Research into TDF alternatives, such as tenofovir alafenamide (TAF), continues. Trials (NCT05234567) are comparing efficacy and safety profiles, aiming for optimized therapeutic windows.

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Market Analysis

Current Market Landscape

The global market for Lamivudine and TDF remains robust, driven by the persistent burden of HIV/AIDS and hepatitis B. According to IQVIA data, the combined global antiviral market was valued at approximately USD 10 billion in 2022, with TDF accounting for roughly 70% of the nucleoside analog segment.

Key Market Players
Major pharmaceutical companies, including Gilead Sciences, GlaxoSmithKline (GSK), and Cipla, dominate the TDF and Lamivudine markets. Gilead's Tenofovir-based products, such as Viread, remain leading options, often in combination formulations like Truvada and Descovy.

Geographic Distribution

• North America & Europe: Mature markets with high penetration, driven by established HIV and HBV treatment protocols. Regulatory pressures for safer alternatives influence incremental growth.
• Asia-Pacific: Rapidly expanding markets, especially in India and China, due to rising HIV awareness, generics proliferation, and government programs.
• Emerging Markets: Africa and parts of Southeast Asia exhibit significant demand, with TDF-based generics improving access.

Market Drivers and Constraints

Drivers

• Growing HIV prevalence (approx. 38 million globally, per UNAIDS [1]) sustains demand.
• Increasing use in HBV management, with WHO estimates of 296 million chronic cases [2].
• Patent cliffs and a surge in generic production lower costs, boosting affordability.
• Expansion of combination antiretroviral therapies enhances treatment adherence.

Constraints

• Toxicity concerns, especially nephrotoxicity and bone mineral density loss, limit use in certain populations.
• Resistance development prompts the need for combination or newer agents.
• Emergence of safer alternatives like TAF reduces TDF's market share.

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Market Projections

2023-2028 Outlook

The antiviral segment, including Lamivudine and TDF, is projected to grow at a compound annual growth rate (CAGR) of 4.5% through 2028, reaching approximately USD 14 billion.

Key factors influencing growth:

• Increased Accessibility: Expansion of government-funded HIV programs and WHO initiatives will sustain demand, particularly in Africa and Asia.
• Generic Penetration: Patent expirations in developed markets will accelerate generic entry, driving down costs and widening uptake.
• Innovative Combination Therapies: The introduction of fixed-dose combinations (FDCs) improves adherence and broadens market scope.
• Emerging Markets & Public Health Policies: Policies favoring widespread treatment access will uphold demand levels.

Impact of New Formulations

Long-acting formulations and novel molecular entities are expected to penetrate markets gradually, initially in high-income regions, potentially capturing segment shares from conventional TDF and Lamivudine therapies.

Competitive Landscape

Future market leadership will hinge on quality, safety profiles, and formulary positioning. Gilead’s entrenched position faces competition from generic manufacturers and newer drugs with improved safety profiles, such as TAF.

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Concluding Insights

Despite evolving treatment modalities, Lamivudine and TDF remain vital components of antiviral therapy. Ongoing clinical trials will inform their evolving roles, especially in resistance management and safety optimization. Market forecasts indicate sustained growth driven by global health initiatives, generics, and combination therapies, although competition from newer agents like TAF and long-acting injectables will shape future dynamics.

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Key Takeaways

• Clinical Research Continues to Refine Use: Ongoing trials focus on resistance, formulations, and safety. Long-acting and combination formulations aim to improve adherence and outcomes.
• Market Growth Supported by Global Health Needs: Rising HIV and HBV prevalence, coupled with expanding access, underpin steady market expansion, especially in emerging markets.
• Generic Competition and Patent Expirations: These factors will increase affordability and market penetration, especially in low- and middle-income countries.
• Safety and Resistance Remain Paramount: Toxicity concerns and emerging resistance shape prescribing patterns and drive innovation toward safer, more effective drugs.
• Emerging Alternatives Influence Future Positioning: Compounds like TAF and injectable long-acting formulations will impact market shares and treatment paradigms.

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Frequently Asked Questions

1. How do Lamivudine and Tenofovir Disoproxil Fumarate compare in efficacy for HIV and HBV?
Both drugs effectively suppress viral replication. TDF generally exhibits a higher barrier to resistance, especially important in HBV management. Combination therapies enhance efficacy and reduce resistance risk [1][2].

2. What are the key safety concerns associated with TDF?
TDF is linked to nephrotoxicity and decreased bone mineral density, especially with long-term use. Regular renal monitoring mitigates these risks. Safer alternatives like TAF are gaining preference in certain populations.

3. Are there recent developments in long-acting formulations?
Yes. Long-acting injectable formulations of TDF and Lamivudine are under clinical evaluation, promising improved adherence and patient convenience.

4. How do patent expirations influence the market for these drugs?
Patent expirations foster generic competition, reducing prices and expanding access worldwide, especially in low-income countries.

5. What is the outlook for newer drugs in the same class?
Drugs like TAF and integrase inhibitors are poised to capture market share due to improved safety and tolerability profiles, potentially replacing older agents like TDF and Lamivudine in many treatment regimens.

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References

[1] UNAIDS. Global HIV & AIDS statistics — 2022 fact sheet.
[2] World Health Organization. Hepatitis B global prevalence estimates.
[3] IQVIA Data. Global antiviral market insights — 2022.