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.

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.

Clinical Trial Conditions for LAMIVUDINE

Condition Name

Condition Name for LAMIVUDINE
Intervention	Trials
HIV Infections	296
HIV	55
Chronic Hepatitis B	53

Condition MeSH

Condition MeSH for LAMIVUDINE
Intervention	Trials
HIV Infections	384
Hepatitis B	130
Hepatitis	126

Clinical Trial Locations for LAMIVUDINE

Trials by Country

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−

Trials by Country for LAMIVUDINE
Location	Trials
South Africa	82
Puerto Rico	76
United Kingdom	71
France	63
Thailand	56

Trials by US State

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−

Trials by US State for LAMIVUDINE
Location	Trials
California	185
New York	154
Florida	142
Texas	125
Illinois	121

Clinical Trial Progress for LAMIVUDINE

Clinical Trial Phase

Clinical Trial Phase for LAMIVUDINE
Clinical Trial Phase	Trials
Phase 4	191
Phase 3	165
Phase 2/Phase 3	17

Clinical Trial Status

Clinical Trial Status for LAMIVUDINE
Clinical Trial Phase	Trials
Completed	433
Unknown status	72
Recruiting	43

Clinical Trial Sponsors for LAMIVUDINE

Sponsor Name

Sponsor Name for LAMIVUDINE
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	112
GlaxoSmithKline	65
ViiV Healthcare	63

Sponsor Type

Sponsor Type for LAMIVUDINE
Sponsor	Trials
Other	692
Industry	404
NIH	159

Lamivudine: Clinical Trials, Market Analysis, and Projections

Introduction to Lamivudine

Lamivudine, an antiretroviral medication, is widely used in the treatment of HIV/AIDS and chronic hepatitis B. Its efficacy and affordability have made it a cornerstone in the management of these infectious diseases globally.

Clinical Trials Update

Dosing Strategies for Preterm Infants

Recent clinical trials have focused on optimizing lamivudine dosing for preterm infants exposed to HIV. A study published in 2024 developed a population pharmacokinetic model to predict the optimal dosing strategy for preterm infants from 24 to 37 weeks of gestation. The model suggested a twice-daily dosing of 2 mg/kg for infants born between 24 and 30 weeks of gestation, and 2 mg/kg twice daily for the first 4 weeks followed by 4 mg/kg twice daily until they weigh 3 kg for those born between 30 and 37 weeks[1].

Efficacy in Diverse Patient Populations

ViiV Healthcare has presented real-world data supporting the use of lamivudine in diverse patient populations. The DOLCE study, for instance, showed that the two-drug regimen Dovato (dolutegravir/lamivudine) achieved similar viral suppression results compared to a three-drug regimen in adults with advanced HIV[5].

Additionally, real-world data from a London teaching hospital confirmed the efficacy of dolutegravir-based dual therapy, including combinations with lamivudine, in achieving high rates of viral suppression with minimal treatment failure[4].

Long-Acting Therapies

The use of long-acting therapies, such as cabotegravir + rilpivirine (CAB+RPV LA), has also been explored. These therapies have shown promising results in both clinical trials and real-world settings, offering an alternative to daily oral treatments and improving adherence and persistence among patients[3].

Market Analysis

Market Size and Growth

The lamivudine drugs market is expected to grow significantly due to the increasing prevalence of HIV/AIDS and hepatitis B globally. The market size is projected to be driven by the high demand for antiretroviral medications, particularly in developing countries where these diseases are more prevalent.

As of the forecast period from 2025 to 2030, the lamivudine drugs market is anticipated to experience substantial growth, with key drivers including the effectiveness and affordability of lamivudine, as well as its inclusion in first-line treatment regimens[2].

Market Segmentation

The lamivudine market can be segmented by therapeutic application, formulation type, dose type, end user, distribution channel, and patient demographics.

• Therapeutic Application: Lamivudine is primarily used for HIV treatment and chronic hepatitis B, with off-label uses also being explored.
• Formulation Type: Oral solutions and tablets are the most common formulations.
• End User: The drug is predominantly used in hospitals, clinics, and specialty care settings, with growing demand in home healthcare[2].

Competitive Landscape

The competitive landscape of the lamivudine market includes several key players such as AbbVie Inc., Aurobindo Pharma Limited, Boehringer Ingelheim Pharmaceuticals, Inc., Cipla Limited, and ViiV Healthcare. These companies are involved in continuous research and development to innovate and improve existing lamivudine formulations.

Porter’s Five Forces Analysis highlights the competitive position of businesses in the lamivudine market, emphasizing the need to understand market strengths, weaknesses, and potential threats to maintain a competitive edge[2].

Market Projections

Revenue Forecast

The global HIV clinical trials market, which includes lamivudine, is expected to grow significantly. By 2034, the market size is projected to reach USD 2.42 billion, up from USD 1.39 billion in 2025. This growth is driven by the increasing number of clinical trials and the expanding need for effective antiretroviral therapies[5].

Regional Analysis

The market growth is expected to be robust across various regions, including North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa. Emerging economies with rising healthcare infrastructures are particularly promising for market expansion[2].

Challenges and Opportunities

Despite the growth potential, the lamivudine market faces several challenges, including a stringent regulatory framework, adverse side effects, and increased generic competition. However, opportunities exist in tailoring drug formulations for specific population segments and exploring market entry strategies in emerging economies[2].

Key Takeaways

• Optimized Dosing: Clinical trials have established pragmatic dosing strategies for lamivudine in preterm infants, ensuring effective treatment.
• Efficacy in Diverse Populations: Real-world data supports the use of lamivudine in diverse patient populations, including those with advanced HIV.
• Market Growth: The lamivudine market is projected to grow significantly due to increasing demand and the effectiveness of the drug.
• Competitive Landscape: Key players are continuously innovating to maintain their competitive edge in the market.
• Regional Expansion: Emerging economies offer significant opportunities for market growth.

FAQs

What is the current dosing strategy for lamivudine in preterm infants?

The current dosing strategy for lamivudine in preterm infants involves a twice-daily dose of 2 mg/kg for those born between 24 and 30 weeks of gestation, and 2 mg/kg twice daily for the first 4 weeks followed by 4 mg/kg twice daily until they weigh 3 kg for those born between 30 and 37 weeks[1].

How effective is lamivudine in real-world settings?

Real-world data has shown that lamivudine, particularly in combination with dolutegravir, achieves high rates of viral suppression with minimal treatment failure in diverse patient populations[4].

What are the key drivers of the lamivudine market growth?

The key drivers include the effectiveness and affordability of lamivudine, its inclusion in first-line treatment regimens, and the growing prevalence of HIV/AIDS and hepatitis B globally[2].

Who are the major players in the lamivudine market?

Major players include AbbVie Inc., Aurobindo Pharma Limited, Boehringer Ingelheim Pharmaceuticals, Inc., Cipla Limited, and ViiV Healthcare[2].

What are the challenges faced by the lamivudine market?

Challenges include a stringent regulatory framework, adverse side effects, and increased generic competition[2].

Sources

1. Lamivudine dosing for preterm infants exposed to HIV - PubMed
2. Lamivudine Drugs Market Size & Share 2025-2030 - 360iResearch
3. ViiV Healthcare expands on real-world data supporting use of long-acting therapies - ViiV Healthcare
4. Real-world data confirm the efficacy of dolutegravir-based dual therapy - AIDSmap
5. HIV Clinical Trials Market Size Expected to Hit USD 2.42 Billion by 2034 - BioSpace