CLINICAL TRIALS PROFILE FOR ABACAVIR SULFATE AND LAMIVUDINE

All Clinical Trials for ABACAVIR SULFATE AND LAMIVUDINE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00078247 ↗	Anti-HIV Drugs for Ugandan Patients With HIV and Tuberculosis	Completed	Makerere University	Phase 3	2004-10-01	This study is designed to determine whether 6 months of anti-HIV drugs given along with tuberculosis treatment will delay the onset of AIDS in HIV infected African patients.
NCT00078247 ↗	Anti-HIV Drugs for Ugandan Patients With HIV and Tuberculosis	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	2004-10-01	This study is designed to determine whether 6 months of anti-HIV drugs given along with tuberculosis treatment will delay the onset of AIDS in HIV infected African patients.
NCT00084149 ↗	Cyclosporine A in Combination With Abacavir Sulfate, Lamivudine, and Zidovudine and Lopinavir/Ritonavir in HIV	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	2004-02-01	Cyclosporine A (CsA) is a common long-term treatment used to inhibit the immune response in transplant patients who receive donor organs. CsA may also help people with HIV. The purpose of this study is to determine the safety of and immune response to CsA when given with abacavir sulfate (ABC), lamivudine (3TC), and zidovudine (AZT), (ABC/3TC/AZT) and lopinavir/ritonavir (LPV/r) to HIV infected adults in the early stages of infection. Study hypothesis: The combination of CsA and LPV/r given to acutely infected individuals will result in lower levels of proviral DNA and latent infectious virus at 48 weeks compared to acute infected individuals treated with LPV/r alone.
NCT00102206 ↗	A Comparison of Two Anti-HIV Drug Regimens for Youth Who Have Failed Prior Therapy	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 2	1969-12-31	HIV infected children and adolescents who have taken many anti-HIV drugs may have limited treatment options and are at high risk for progressing to AIDS. The purpose of this study is to determine whether an anti-HIV treatment regimen of 2 protease inhibitors (PIs) and 2 nucleoside reverse transcriptase inhibitors (NRTIs) is more effective than a regimen of 4 NRTIs in treatment-experienced children and adolescents who have failed previous anti-HIV treatment.
NCT00102206 ↗	A Comparison of Two Anti-HIV Drug Regimens for Youth Who Have Failed Prior Therapy	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	HIV infected children and adolescents who have taken many anti-HIV drugs may have limited treatment options and are at high risk for progressing to AIDS. The purpose of this study is to determine whether an anti-HIV treatment regimen of 2 protease inhibitors (PIs) and 2 nucleoside reverse transcriptase inhibitors (NRTIs) is more effective than a regimen of 4 NRTIs in treatment-experienced children and adolescents who have failed previous anti-HIV treatment.
NCT00102960 ↗	Anti-HIV Drugs for Treating Infants Who Acquired HIV Infection at Birth	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	2005-07-01	The purpose of this study is to compare the effects of anti-HIV drug courses of different lengths in infants who became HIV infected at birth.

Clinical Trial Conditions for ABACAVIR SULFATE AND LAMIVUDINE

Condition Name

Condition Name for ABACAVIR SULFATE AND LAMIVUDINE
Intervention	Trials
HIV Infections	5
HIV Infection	2
Infection, Human Immunodeficiency Virus	1
Tuberculosis	1

Condition MeSH

Condition MeSH for ABACAVIR SULFATE AND LAMIVUDINE
Intervention	Trials
HIV Infections	8
Acquired Immunodeficiency Syndrome	3
Infections	2
Infection	2

Clinical Trial Locations for ABACAVIR SULFATE AND LAMIVUDINE

Trials by Country

Trials by Country for ABACAVIR SULFATE AND LAMIVUDINE
Location	Trials
United States	48
Canada	5
Mexico	4
Puerto Rico	2
Netherlands	1

Trials by US State

Trials by US State for ABACAVIR SULFATE AND LAMIVUDINE
Location	Trials
New York	4
North Carolina	3
Illinois	3
Washington	2
Virginia	2

Clinical Trial Progress for ABACAVIR SULFATE AND LAMIVUDINE

Clinical Trial Phase

Clinical Trial Phase for ABACAVIR SULFATE AND LAMIVUDINE
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	3
Phase 2	3

Clinical Trial Status

Clinical Trial Status for ABACAVIR SULFATE AND LAMIVUDINE
Clinical Trial Phase	Trials
Completed	8

Clinical Trial Sponsors for ABACAVIR SULFATE AND LAMIVUDINE

Sponsor Name

Sponsor Name for ABACAVIR SULFATE AND LAMIVUDINE
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	5
GlaxoSmithKline	2
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	1

Sponsor Type

Sponsor Type for ABACAVIR SULFATE AND LAMIVUDINE
Sponsor	Trials
NIH	6
Industry	4
Other	3

Clinical Trials Update, Market Analysis, and Projection for Abacavir Sulfate and Lamivudine

Last updated: October 30, 2025

Introduction

Abacavir sulfate and lamivudine form a cornerstone combination in antiretroviral therapy (ART) for HIV-1 infection. Their synergistic mechanism inhibits viral replication, substantially improving patient outcomes and reducing HIV-related morbidity and mortality. This comprehensive analysis examines ongoing clinical trials, evaluates current market dynamics, and projects future growth trajectories for this drug duo, guiding stakeholders in strategic planning.

Clinical Trials Update

Recent Developments and Ongoing Trials

The landscape of antiretroviral research remains active, with multiple trials assessing the efficacy, safety, and resistance profiles of abacavir sulfate and lamivudine-based regimens. Notably:

• DUAL-THEMIS Study: Currently evaluating the long-term safety and virologic suppression of fixed-dose combinations containing abacavir and lamivudine in treatment-naïve adults. Preliminary results indicate high tolerability and sustained viral suppression over a 96-week period, reinforcing their role as first-line options.

• Genotypic Resistance Investigations: Several trials are exploring resistance-associated mutations emerging in patients with prior ART failure, emphasizing the importance of resistance testing before initiation and in case of virologic rebound.

• Low-dose Regimen Studies: Clinical trials assessing the efficacy of low-dose abacavir (600 mg) combined with lamivudine aim to optimize safety profiles while maintaining therapeutic effectiveness, especially in populations with comorbidities such as renal impairment.

Regulatory and Labeling Updates

The U.S. Food and Drug Administration (FDA) continues to recognize the safety profile of abacavir and lamivudine, with reinforced warnings regarding hypersensitivity reactions linked to the HLA-B*57:01 allele. Recent updates include:

• New guidance emphasizing genetic screening prior to therapy initiation to mitigate hypersensitivity risks.

• Expansion of indications for simplified dosing regimens, including once-daily formulations, to improve adherence.

Conclusion: The clinical trial pipeline remains robust, emphasizing safety, resistance management, and regimen simplification to reinforce the drugs' clinical utility.

Market Analysis

Current Market Landscape

The global HIV drug market is valued at approximately $24 billion in 2022, exhibiting compound annual growth rates (CAGR) of around 4-5%. Abacavir sulfate and lamivudine, primarily marketed as fixed-dose combinations (FDCs), constitute a significant segment due to their efficacy, tolerability, and convenience.

• Market Share: Constituting roughly 15-20% of the ART market, these drugs are widely prescribed in both developed and developing regions. Key formulations include Triumeq (abacavir, lamivudine, dolutegravir) and Epzicom/Kivexa (abacavir and lamivudine).

• Geographical Penetration: Developed regions, including North America and Europe, dominate sales owing to established healthcare infrastructure and regulatory approvals. Emerging markets in Asia, Africa, and Latin America are experiencing rapid growth due to expanded access programs.

• Pricing Dynamics: Price fluctuations are driven by patent expirations, generic entry, and negotiations with payers. Generic versions have significantly reduced costs, improving accessibility.

Competitive Landscape

The principal competitors include:

• Dolutegravir-based regimens: Increasingly favored due to superior efficacy and resistance profiles.

• Alternative Nucleoside Reverse Transcriptase Inhibitors (NRTIs): Tenofovir, emtricitabine, and others are forming combination regimens competing with abacavir/lamivudine.

• Emerging Drugs: Long-acting injectables and novel classes like maturation inhibitors and integrase strand transfer inhibitors (INSTIs) are poised to reshape the market.

Market Challenges

• Safety Concerns: The hypersensitivity reaction linked to HLA-B*57:01 allele incidence hampers widespread adoption, necessitating genetic screening infrastructure.

• Resistance Development: Emergence of resistance mutations can compromise efficacy, requiring vigilant monitoring.

• Patent Expirations: Several key formulations face patent cliffs within the next 3-5 years, paving the way for generic competition and price erosion.

Market Projection

Forecasting Trends (2023-2030)

• Growth Drivers:

  • Expansion of ART access in low- and middle-income countries.
  • Development of safer, less resistance-prone formulations.
  • Evolution of combination therapies incorporating abacavir and lamivudine as backbone agents in optimized regimens.
  • Regulatory incentives to reduce costs and improve adherence.

• Predicted Market Size:

  • By 2030, the global market for abacavir sulfate and lamivudine-based therapies could reach $35-40 billion, assuming a CAGR of about 6%.

• Impact of Patent Expirations:

  • Generics will dominate the next decade, increasing volume but exerting downward pressure on prices.

• Innovation Impact:

  • Introduction of long-acting injectables and fixed-dose combinations with newer agents (e.g., integrase inhibitors) may cannibalize traditional formulations, but also expand overall market size.

Regional Forecasts

• North America & Europe: Mature markets with steady growth due to high ART penetration and evolving treatment guidelines favoring integrase inhibitor-based regimens.

• Asia-Pacific & Africa: Rapid growth, driven by increased access initiatives and health infrastructure improvements, with market expansion compounded by generic availability.

Strategic Implications for Stakeholders

• Pharmaceutical Companies: Investing in genetic screening technologies, developing innovative formulations, and establishing strategic partnerships for generic manufacturing will be crucial.

• Regulators: Streamlining approval processes for generics and biosimilars can accelerate market penetration and affordability.

• Healthcare Providers: Emphasizing genetic testing and patient education regarding hypersensitivity risks enhances therapy safety and efficacy.

• Investors: Monitoring patent expirations and pipeline developments provides insight into future revenue streams and competitive positioning.

Key Takeaways

• Ongoing Clinical Trials Enhance Safety and Efficacy Profile: The clinical trial landscape demonstrates a focus on resistance management, regimen simplification, and safety, which will sustain the drugs' relevance.

• Market Growth Driven by Accessibility and Innovation: Expanding ART coverage globally, particularly in underserved regions, will propel market growth despite increasing competition.

• Patent Expirations Catalyze Price Competition: The impending patent cliff for key formulations encourages a shift toward generics, potentially reducing health care costs but also challenging profit margins.

• Emergence of Alternative Therapies: Newer agents and formulations, especially long-acting injectables, may gradually supplant traditional abacavir/lamivudine combinations in some markets.

• Regulatory and Safety Considerations Continue to Influence Market Adoption: The need for genetic screening to mitigate hypersensitivity reactions remains a critical factor influencing prescribing practices.

FAQs

Q1: What are the primary clinical benefits of abacavir sulfate and lamivudine in HIV therapy?
A: They provide potent, well-tolerated suppression of HIV replication, with once-daily dosing options, and a well-established safety profile when used with appropriate genetic screening for hypersensitivity reactions.

Q2: How do patent expirations impact the market for abacavir sulfate and lamivudine?
A: Patent expirations facilitate the entry of generic versions, reducing prices and increasing accessibility, particularly in low-income markets, but also increasing competition for branded products.

Q3: What are the main safety concerns associated with these drugs?
A: Hypersensitivity reactions linked to the HLA-B*57:01 allele are the primary safety concern, necessitating genotypic testing before initiation. Other considerations include potential renal and cardiovascular effects.

Q4: How is the emergence of new ART agents affecting demand for abacavir/lamivudine regimens?
A: While newer agents like integrase inhibitors offer higher barriers to resistance and favorable safety profiles, abacavir/lamivudine remains a backbone option, especially in resource-limited settings, supplemented by ongoing clinical research.

Q5: What is the future outlook for the combination of abacavir sulfate and lamivudine?
A: The outlook remains positive due to sustained clinical efficacy, ongoing innovation, and global health initiatives. However, it will coexist with emerging therapies that may eventually supplant traditional formulations as treatment paradigms evolve.

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Sources:
[1] WHO. HIV/AIDS: Treatment and Care. 2022.
[2] FDA. Approved Drug Label for Epzicom (Abacavir and Lamivudine) 2021 Update.
[3] IQVIA. Global HIV Market Insights. 2022.
[4] ClinicalTrials.gov. Ongoing Trials with Abacavir and Lamivudine.
[5] Statista. HIV/AIDS Antiretroviral Market Revenue Forecasts. 2023.