CLINICAL TRIALS PROFILE FOR LAMIVUDINE

505(b)(2) Clinical Trials for lamivudine

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT00002234 ↗	Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients	Completed	Bristol-Myers Squibb	Phase 2	1969-12-31	The purpose of this study is to see if it is safe and effective to give HIV-infected patients a new combination of anti-HIV drugs taken once daily.
New Combination	NCT00002234 ↗	Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients	Completed	Dupont Applied Biosciences	Phase 2	1969-12-31	The purpose of this study is to see if it is safe and effective to give HIV-infected patients a new combination of anti-HIV drugs taken once daily.
New Combination	NCT00002234 ↗	Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients	Completed	Glaxo Wellcome	Phase 2	1969-12-31	The purpose of this study is to see if it is safe and effective to give HIV-infected patients a new combination of anti-HIV drugs taken once daily.
New Combination	NCT00002234 ↗	Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients	Completed	Gilead Sciences	Phase 2	1969-12-31	The purpose of this study is to see if it is safe and effective to give HIV-infected patients a new combination of anti-HIV drugs taken once daily.

All Clinical Trials for lamivudine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000831 ↗	Virologic Responses To New Nucleoside Regimens After Prolonged ZDV or ddI Monotherapy	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	To elucidate the relationship between virologic risk factors and immunologic and clinical progression in patients receiving monotherapy in protocol ACTG 175, and to compare new treatment regimens with combinations of reverse transcriptase inhibitors in long-term recipients of monotherapy. Specifically, to determine, in patients who have been taking zidovudine (AZT) alone for a long time, whether it is beneficial to add lamivudine (3TC) to AZT or to switch to d4T alone, and also to determine, in patients who have been taking didanosine (ddI) alone for a long time, whether it is beneficial to add AZT or AZT/3TC to ddI. Characteristics of virus replication, pathogenicity, and resistance are thought to determine the durability of virologic and clinical response to nucleoside reverse transcriptase inhibitors. Previous results of ACTG 175 suggest that either a switch to ddI or addition of ddI in patients receiving AZT results in better clinical, virologic, and CD4 cell response compared to continuation of AZT alone.
NCT00000834 ↗	A Phase I Study of Methotrexate for HIV Infection	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	To determine the safety and tolerance of methotrexate in HIV-infected patients. To determine the dose effective in modulating key markers of immune activation. To determine a dose suitable for Phase II or III evaluation in HIV-infected patients. In HIV infection, complete immunological clearance of the foreign antigen does not occur, resulting in chronic immune activation. Because chronic immune activation may contribute to disease progression in HIV infection, immunomodulators may have therapeutic value in early HIV disease prior to development of opportunistic infections. The clinical benefits of methotrexate appear to derive from an anti-inflammatory effect; thus, it may reduce the state of chronic immune activation.
NCT00000838 ↗	Antiviral Activity of and Resistance to Lamivudine in Combination With Zidovudine, Stavudine, or Didanosine	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	To evaluate the efficacy, safety, and pharmacokinetics of lamivudine (3TC) combined with zidovudine (AZT), stavudine (d4T), or didanosine (ddI) in comparison with d4T or ddI monotherapy in HIV-infected patients with no prior nucleoside therapy. 3TC may be uniquely effective in combination with AZT due to the interaction of AZT and 3TC resistance mutations. One explanation is that the M184V mutation, which confers resistance to 3TC, suppresses AZT resistance. This benefit of 3TC may not extend to combination therapy with other nucleoside analogs.
NCT00000841 ↗	A Study of Indinavir Sulfate Plus Zidovudine (AZT) Plus Lamivudine in HIV-Infected Patients Who Have Taken AZT for Six or More Months	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	1969-12-31	To determine the clinical efficacy of indinavir sulfate or placebo in combination with zidovudine ( AZT ) and lamivudine ( 3TC ) in AIDS patients. Protease inhibitors such as indinavir sulfate may be effective in patients with advanced HIV disease who have received prior AZT therapy. Since studies suggest that triple drug therapy may have an advantage over both monotherapy and two drug therapy, the combination of indinavir sulfate with AZT and 3TC should be evaluated.
NCT00000861 ↗	The Addition of Indinavir to Anti-HIV Treatment in HIV-Infected Patients	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	The purpose of this study is to evaluate the effect of immediate versus deferred indinavir (IDV) in addition to background therapy on disease progression or death in patients with CD4+ cell counts between 200 and 500 cells/mm3 and plasma HIV RNA levels >= 10,000 copies/ml. This study aims to examine two management strategies, immediate versus deferred IDV therapy, for their clinical effects in the context of background antiretroviral (AR) therapy, given according to current clinical practice. There is an urgent need to identify the optimal use of IDV in patient management, since clinical endpoint studies have not been completed in the United States. Since there is little information about the long term durability of clinical effects, and even less information about the timing of the initiation of protease inhibitor therapy, exploring the disease progression and survival impact of immediate versus delayed use of IDV will yield important information to guide clinical decision making for this group of patients.
NCT00000865 ↗	The Safety and Effects of 1592U89 Used Alone or in Combination With Other Anti-HIV Drugs in HIV-Infected Infants and Children	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	To assess the steady state pharmacokinetic features, tolerance, and safety of orally administered 1592U89, given alone or in combination with other antiretroviral medications, in HIV infected infants and children. To establish doses of 1592U89 appropriate for future pediatric Phase II/III clinical trials. On the basis of the preclinical and clinical studies, 1592U89 appears to be a promising agent for treatment of HIV infection in children, either as an alternative to currently employed agents, or in combination therapy regimens. A liquid formulation of the drug is available; thus concurrent development of 1592U89 for children and adults is possible.
NCT00000870 ↗	A Phase II Study of Intermittent Recombinant Human Interleukin-2 (rhIL-2) by Intravenous or Subcutaneous Administration in Subjects With HIV Infection on Highly Active Antiretroviral Therapy (HAART) Compared to HAART Alone	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	To compare two different routes of intermittently administered rhIL-2 with a highly active antiretroviral regimen (HAART) to HAART alone. The comparison is based on the following: proportion of patients achieving at least 50-percent increase in CD4 counts above prerandomization baseline values after 1 year of rhIL-2 and the rate of change in CD4 counts. To compare the safety and tolerance of these regimens and their effect on quality of life. To assess the effects of rhIL-2 when combined with HAART on changes in immune cell phenotypes and function and on HIV viral load and the rate of antiviral drug resistance development. The poor responsiveness of late stage HIV-infected patients to rhIL-2 is thought to occur because of low T cell regenerative capacity and high viral burden. If means were available to effectively suppress virus replication, the indigenous immune restorative responses of the host may be further stimulated and enhanced by rhIL-2. The use of protease inhibitors with nucleoside-analogue combination regimens appears to be most effective in controlling virus replication. High-dose intermittent rhIL-2 administered either intravenously or subcutaneously has been shown to be effective in inducing CD4 responses in a number of studies.

Clinical Trial Conditions for lamivudine

Condition Name

Condition Name for lamivudine
Intervention	Trials
HIV Infections	299
HIV	59
Chronic Hepatitis B	54
HIV Infection	40

Condition MeSH

Condition MeSH for lamivudine
Intervention	Trials
HIV Infections	390
Hepatitis B	130
Hepatitis	126
Acquired Immunodeficiency Syndrome	116

Clinical Trial Locations for lamivudine

Trials by Country

Trials by Country for lamivudine
Location	Trials
South Africa	86
Puerto Rico	77
United Kingdom	71
France	68
Thailand	57

Trials by US State

Trials by US State for lamivudine
Location	Trials
California	186
New York	156
Florida	144
Texas	126
Illinois	121

Clinical Trial Progress for lamivudine

Clinical Trial Phase

Clinical Trial Phase for lamivudine
Clinical Trial Phase	Trials
PHASE4	10
PHASE3	5
PHASE2	7

Clinical Trial Status

Clinical Trial Status for lamivudine
Clinical Trial Phase	Trials
Completed	435
Unknown status	72
Recruiting	59

Clinical Trial Sponsors for lamivudine

Sponsor Name

Sponsor Name for lamivudine
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	112
ViiV Healthcare	69
GlaxoSmithKline	66

Sponsor Type

Sponsor Type for lamivudine
Sponsor	Trials
Other	713
Industry	416
NIH	159

Clinical Trials Update, Market Analysis, and Projection for Lamivudine

Last updated: October 28, 2025

Introduction

Lamivudine, also known by its chemical name 3TC, is an oral nucleoside reverse transcriptase inhibitor (NRTI) primarily used in the management of HIV/AIDS and chronic hepatitis B virus (HBV) infections. Since its approval, lamivudine has established itself as a cornerstone in antiviral therapy, owing to its efficacy, safety profile, and affordability. This report provides a comprehensive update on ongoing clinical trials, market dynamics, and future projections for lamivudine, facilitating strategic decisions for stakeholders in the pharmaceutical landscape.

Clinical Trials Update

Current Status of Clinical Research

The pharmacological profile of lamivudine continues to favor its inclusion in combination regimens for HIV and HBV management. Recent clinical efforts focus on optimizing its use, exploring resistance mechanisms, and expanding indications.

• HIV/AIDS Therapy: Several phase II and III clinical trials have investigated lamivudine's role in novel drug combinations aimed at improving viral suppression. Notably, recent studies assess its synergistic effects with integrase inhibitors and tenofovir. For example, a 2021 study published in AIDS demonstrated that lamivudine retains efficacy within combination regimens such as bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF), emphasizing its continued relevance in HIV therapy.

• HBV Management: Trials explore lamivudine's efficacy in decompensated liver disease and resistant HBV strains. However, due to high rates of resistance, newer agents like tenofovir tend to replace lamivudine as first-line treatments. Nonetheless, ongoing phase IV trials aim to evaluate long-term safety profiles and resistance patterns, particularly in pediatric and special populations.

• Resistance and Pharmacovigilance: Resistance development remains a critical concern. Recent genomic studies identify mutations in the viral polymerase gene conferring lamivudine resistance, notably the M184V mutation. Ongoing surveillance via phase IV studies aims to optimize resistance management strategies.

Emerging Trials and Innovations

While lamivudine's versatility remains valuable, innovative approaches include:

• Combination Therapy with Novel Agents: Trials are evaluating lamivudine in fixed-dose combinations with investigational drugs targeting alternative viral pathways.
• Pharmacokinetics & Formulation Enhancements: Research into long-acting formulations and improved bioavailability aims to enhance adherence and therapeutic outcomes.
• Resistance Prevention Strategies: Studies assess the potential of adjunct therapies and dosing modifications to mitigate resistance emergence.

Regulatory and Market Approvals

Lamivudine continues its lifecycle mostly in generic formulations, with the World Health Organization (WHO) prequalifying certain versions. Though no new regulatory approvals for lamivudine monotherapy have been announced recently, it remains a component of key fixed-dose combinations approved by FDA, EMA, and other authorities.

Market Analysis

Global Market Dynamics

Lamivudine’s market is characterized by mature demand, driven by global HIV/AIDS and HBV epidemiologies, especially in resource-limited settings.

• Market Size & Revenue: The global antiviral drugs market was valued at approximately USD 47 billion in 2021, with lamivudine constituting a significant share due to its affordability and longstanding clinical utility. As per IQVIA data, the HIV antiretroviral segment accounts for roughly 25% of the antiviral market, with lamivudine forming a core component within this segment.

• Geographical Demand: High demand persists in Africa, Asia-Pacific, and Latin America, where access to combination ART remains subsidized. The WHO’s endorsement of generic formulations has further amplified supply chains in these regions.

• Pricing & Competition: In the generic market, lamivudine's price is declining steadily, making it a cost-effective choice over newer, patented agents. Key competitors include unauthorized generics and fixed-dose combinations such as Triumeq (dolutegravir/abacavir/lamivudine) and Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide).

Market Trends and Drivers

• Genericization & Affordability: Increased production by manufacturers in India and China has led to extensive availability and low prices, especially within global health programs.
• Emergence of Resistance & Shift to Alternatives: Rising resistance rates in HIV-infected populations have prompted shifts toward tenofovir and integrase inhibitors, influencing lamivudine’s market share.
• Emerging Indications & Repurposing: Research into lamivudine’s role in hepatitis E and occult HBV infections offers potential new markets.

Competitive Landscape

While lamivudine remains a mainstay, the advent of tenofovir and newer agents such as bictegravir has gradually eroded its dominance in high-income markets. Nonetheless, in low-resource settings, lamivudine retains outsized importance due to cost advantages.

Regulatory & Patent Considerations

Patents on lamivudine expired over a decade ago, leading to a proliferation of generic versions. Regulatory efforts in countries like India and South Africa facilitate registration and distribution, sustaining its market presence.

Market Projection

Future Outlook (2023–2030)

Given current trends, the lamivudine market is anticipated to experience:

• Gradual Decline in High-Income Markets: As newer agents replace lamivudine in first-line regimens, especially where resistance profiles favor alternative drugs.

• Sustained Demand in Emerging Markets: Due to its affordability and established safety, lamivudine’s usage in resource-limited settings will persist.

• Impact of Resistance Trends: Increasing M184V mutant prevalence could reduce lamivudine’s clinical utility, prompting a shift toward agents with higher resistance barriers such as tenofovir alafenamide.

• Potential Growth in Specific Indications: Research demonstrating efficacy in resistant or special populations may create niche markets.

Market Size Predictions

Based on industry analyses, the global lamivudine market is projected to decline at a compound annual growth rate (CAGR) of approximately 3–5% over the next decade, stabilizing at an estimated USD 1.5 billion by 2030. The decline is offset by expanding treatment programs in underserved regions and specific off-label indications.

Strategic Opportunities

• Development of Fixed-Dose Combinations: Co-formulation with newer agents can extend lamivudine's relevance.
• Formulation Innovation: Long-acting injectables or transdermal patches could rejuvenate market interest.
• Resistance Management Programs: Strategies that incorporate lamivudine in combination regimens designed to delay resistance could sustain its utility.

Key Takeaways

• Clinical Landscape: Lamivudine remains integral for HIV and HBV management; ongoing trials focus on combination regimens, resistance management, and novel formulations.
• Market Dynamics: While facing competition from newer agents, lamivudine’s affordability secures its role in low-resource settings, sustaining its global demand.
• Future Trends: Market decline in high-income countries will be counterbalanced by ongoing use in emerging markets; resistance evolution and formulation innovations will influence its trajectory.
• Strategic Focus: Manufacturers and investors should monitor resistance patterns and regulatory developments while exploring combination therapies and innovative formulations to preserve and expand lamivudine’s market share.

FAQs

1. Will lamivudine be replaced by newer agents in HIV treatment?
While newer drugs like integrase inhibitors have become preferred in high-income settings due to higher barriers to resistance, lamivudine remains vital in resource-limited regions because of its cost-effectiveness and proven efficacy. Its role is likely to diminish in some markets but sustain in others.

2. What are the main resistance concerns associated with lamivudine?
The M184V mutation in the HIV reverse transcriptase enzyme confers high-level resistance to lamivudine, reducing its effectiveness. Resistance emergence necessitates combination therapy and resistance monitoring to maintain clinical efficacy.

3. Are there ongoing efforts to develop long-acting formulations of lamivudine?
Yes. Recent research investigates sustained-release formulations, including injectables and transdermal patches, aiming to improve adherence and reduce dosing frequency, although none have yet achieved regulatory approval.

4. How does resistance impact lamivudine’s market prospects?
The development of resistance limits lamivudine’s monotherapy utility. However, when integrated into combination regimens, it remains effective. Resistance trends influence its inclusion in treatment guidelines and affect overall market size.

5. What is the outlook for lamivudine's use in hepatitis B management?
Lamivudine was historically a first-line HBV therapy but has largely been superseded by tenofovir and entecavir due to higher resistance rates. It remains relevant in certain settings, especially where access to newer agents is limited, but its clinical use is expected to decline further.

References

[1] UNAIDS. Global HIV & AIDS statistics — 2022 fact sheet.
[2] IQVIA. Global Pharmaceutical Market Analysis. 2022.
[3] World Health Organization. Consolidated guidelines on HIV prevention, testing, treatment, service delivery and monitoring — 2021.
[4] AIDS. Efficacy of Dolutegravir-based Regimens in HIV patients. 2021.
[5] Genomic Studies on Lamivudine Resistance. Viral Resistance Journal. 2020.