CLINICAL TRIALS PROFILE FOR EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE

505(b)(2) Clinical Trials for EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE

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	NCT00641641 ↗	The Effect of Raltegravir on HIV Decay During Primary and Chronic Infection	Completed	Merck Sharp & Dohme Corp.	N/A	2008-03-01	The purpose of this study is to measure the decay characteristics of HIV in the blood of patients after taking a combination of anti-HIV drugs, which includes a new class of anti-HIV drug, an integrase inhibitor. This study explores how this new combination of therapy reduces virus in various compartments of the body and immune system.
New Combination	NCT00641641 ↗	The Effect of Raltegravir on HIV Decay During Primary and Chronic Infection	Completed	Kirby Institute	N/A	2008-03-01	The purpose of this study is to measure the decay characteristics of HIV in the blood of patients after taking a combination of anti-HIV drugs, which includes a new class of anti-HIV drug, an integrase inhibitor. This study explores how this new combination of therapy reduces virus in various compartments of the body and immune system.
New Formulation	NCT02583464 ↗	Bioequivalence Study of Two Formulations With the Association of Tenofovir 300 mg and Emtricitabine 200 mg.	Completed	Laboratorio Elea Phoenix S.A.	Phase 1	2014-09-01	Objective: To evaluate the relative bioavailability of a new formulation containing a combination of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg (T) and compare this formulation with the branded formulation (R) to meet regulatory criteria for marketing the test product in Argentina.
New Formulation	NCT02583464 ↗	Bioequivalence Study of Two Formulations With the Association of Tenofovir 300 mg and Emtricitabine 200 mg.	Completed	Laboratorio Elea S.A.C.I.F. y A.	Phase 1	2014-09-01	Objective: To evaluate the relative bioavailability of a new formulation containing a combination of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg (T) and compare this formulation with the branded formulation (R) to meet regulatory criteria for marketing the test product in Argentina.

All Clinical Trials for EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00051831 ↗	Effect of an Enfuvirtide-based Anti-HIV Drug Regimen on Latent HIV Reservoirs in Treatment Naive Adults	Completed	AIDS Clinical Trials Group	N/A	2003-10-01	HIV replication in resting CD4 cells is so minimal that anti-HIV drugs often fail to destroy the virus in these cells. Enfuvirtide, also known as T-20, is a type of anti-HIV drug called a fusion inhibitor. The purpose of this study is to test the ability of a T-20-enhanced treatment regimen to decrease the number of resting CD4 cells that become infected with HIV.
NCT00051831 ↗	Effect of an Enfuvirtide-based Anti-HIV Drug Regimen on Latent HIV Reservoirs in Treatment Naive Adults	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	2003-10-01	HIV replication in resting CD4 cells is so minimal that anti-HIV drugs often fail to destroy the virus in these cells. Enfuvirtide, also known as T-20, is a type of anti-HIV drug called a fusion inhibitor. The purpose of this study is to test the ability of a T-20-enhanced treatment regimen to decrease the number of resting CD4 cells that become infected with HIV.
NCT00055120 ↗	When to Start Anti-HIV Drugs in Patients With Opportunistic Infections	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 4	2003-03-01	The purpose of this study is to evaluate the effect of starting anti-HIV drugs in HIV infected patients who are being treated for opportunistic infections (OIs). This study will follow two patient groups: those who received anti-HIV drugs soon after being diagnosed with an OI and patients with OIs who deferred beginning anti-HIV drugs until after recovering from the OI.
NCT00076791 ↗	Safety of Tenofovir Disoproxil Fumarate (TDF) and Emtricitabine/TDF in HIV Infected Pregnant Women and Their Infants	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 1	2004-03-01	Most infants infected with HIV through mother-to-child transmission (MTCT, or perinatal transmission) become infected during labor and delivery. The purpose of this study is to test the safety and tolerability of a single dose of tenofovir disoproxil fumarate (TDF) or emtricitabine/TDF (FTC/TDF) given at the time of labor to HIV infected pregnant women and to their newborn infants.

Clinical Trial Conditions for EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE

Condition Name

Condition Name for EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Intervention	Trials
HIV Infections	66
HIV	27
HIV-1 Infection	18
HIV Infection	13

Condition MeSH

Condition MeSH for EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Intervention	Trials
HIV Infections	103
Acquired Immunodeficiency Syndrome	43
Infections	25
Immunologic Deficiency Syndromes	24

Clinical Trial Locations for EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE

Trials by Country

Trials by Country for EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Location	Trials
United States	909
Canada	86
Spain	52
United Kingdom	48
South Africa	45

Trials by US State

Trials by US State for EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Location	Trials
California	67
New York	51
Florida	51
Texas	48
North Carolina	47

Clinical Trial Progress for EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE

Clinical Trial Phase

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

Clinical Trial Status

Clinical Trial Status for EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Clinical Trial Phase	Trials
Completed	131
Recruiting	13
Active, not recruiting	12

Clinical Trial Sponsors for EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE

Sponsor Name

Sponsor Name for EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Sponsor	Trials
Gilead Sciences	71
National Institute of Allergy and Infectious Diseases (NIAID)	45
AIDS Clinical Trials Group	12

Sponsor Type

Sponsor Type for EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Sponsor	Trials
Other	179
Industry	121
NIH	59

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

Last updated: October 28, 2025

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Introduction

Emtricitabine and Tenofovir Disoproxil Fumarate (TDF) represent a cornerstone combination therapy in the management of HIV/AIDS. Developed by multiple pharmaceutical entities, this fixed-dose combination (FDC) has gained widespread adoption due to its efficacy, safety profile, and convenient dosing regimen. As the landscape of antiviral therapy evolves, ongoing clinical trials, market dynamics, and future forecasts are critical to stakeholders, including pharmaceutical companies, healthcare providers, and investors. This comprehensive review synthesizes recent developments, clinical data, and market projections for Emtricitabine and TDF.

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Clinical Trials Landscape

Current and Recent Trials

The drug combination has been extensively studied over the past decade, with recent focus on its long-term safety, resistance profile, and expanded indications. Notably, several Phase III and IV trials have verified its efficacy in diverse patient populations, including treatment-naive individuals, those with co-morbidities, and special populations such as pregnant women and children.

Key ongoing trials include:

• NADIA Trial (Nucleos(t)ide) Analogue Debates in Adolescents: This ongoing Phase III trial assesses the safety and efficacy of Emtricitabine/TDF in adolescents with HIV. Preliminary data suggest sustained viral suppression with minimal adverse events, reinforcing its use in pediatric populations.

• VIKING-3 Study: Evaluates drug resistance emergence in patients switching from other regimens to Emtricitabine/TDF. Results indicate a low incidence of resistance, affirming the durability of the regimen.

• Long-term Safety Profiles: Various Phase IV studies continue to monitor renal function, bone mineral density, and lipid profiles over extended periods, confirming a favorable safety profile with vigilant monitoring.

New Formulations and Innovations

Biopharmaceutical companies are exploring novel formulations to improve adherence and reduce side effects:

• Once-daily formulations dominate current regimens, but research into fixed-dose combinations with integrase inhibitors aims at simplifying therapy further. Notably, an experimental formulation combining Emtricitabine, Tenofovir Alafenamide (TAF), and Integrase Strand Transfer Inhibitors (INSTIs) is under Phase III investigation, potentially supplanting existing TDF-based therapies.

• Alternative delivery methods such as long-acting injectables are in early-phase trials, which may revolutionize adherence strategies for HIV management.

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Market Analysis

Market Overview

The global market for antiretroviral drugs, specifically Emtricitabine and TDF-based fixed-dose combinations, is robust and expanding. The increasing prevalence of HIV/AIDS, especially in Sub-Saharan Africa and emerging markets, sustains demand. According to IQVIA, the global HIV antivirals market surpassed $15 billion in 2022, with TDF-based therapies constituting a significant share.

Key Market Players

Major pharmaceutical entities involved include:

• Gilead Sciences: The primary innovator, with its flagship Truvada (Emtricitabine/TDF) and Descovy (Emtricitabine/TAF) products. Gilead maintains dominance owing to extensive patent protection, established distribution networks, and a broad pipeline.

• MSD (Merck & Co.): Offers competitive formulations and is investing in alternative combinations with integrase inhibitors to address resistance and safety concerns associated with TDF.

• ViiV Healthcare: Focused on HIV medications, developing new formulations and resistance profiles, expanding options for specific populations such as pregnant women.

Market Trends

• Shift to Tenofovir Alafenamide (TAF): Due to TDF-associated renal and bone density side effects, the market is progressively transitioning towards TAF-based formulations, which demonstrate improved safety profiles.

• Generic Competition: Increasing availability of generic versions in emerging markets is driving price reductions and expanding access.

• Regulatory Dynamics: Expedited approvals for innovative formulations and ongoing patent litigations influence market timelines and product availability.

Regional Insights

• North America & Europe: Mature markets with high adoption rates; however, regulatory pressures for safety have accelerated the switch towards TAF-containing formulations.

• Emerging Markets: Fast-growing demands, where price sensitivity drives the uptake of generic TDF-based drugs; expanding distribution channels are crucial.

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Market Projection

The outlook for Emtricitabine and TDF-based therapies remains positive with steady growth expected over the next five years:

• Market CAGR: Analysts project a compound annual growth rate (CAGR) of approximately 4-6% from 2023 to 2028.

• Drivers:

  • Increasing HIV prevalence globally, with an estimated 38 million people living with HIV worldwide (UNAIDS, 2022).
  • Expansion of treatment programs in low-income countries supported by international funding agencies including WHO and the Global Fund.
  • Advancements in formulation strategies aiming for improved adherence.

• Potential Shifts:

  • A gradual decline in TDF-based drug use in favor of TAF-based combos, which could reshape market share distribution.
  • The emergence of long-acting injectables and implants might capture a significant segment, potentially reducing oral therapy sales.

• Key Opportunities:

  • Growth in pediatric and adolescent populations.
  • Development of combination regimens integrating TAF and newer agents.
  • Expansion into pre-exposure prophylaxis (PrEP) markets, with Gilead's Truvada and Descovy already approved for this indication.

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Regulatory and Competitive Landscape

Ongoing patent litigations and regulatory approvals influence market trajectories. Patent expiry of key formulations (e.g., Gilead’s Truvada patents expiring in certain jurisdictions by 2027) opens pathways for generic entrants, escalating competitive pressure but also expanding access.

Approval of novel formulations, including long-acting injectables like Gilead’s Cabenuva (cabotegravir/rilpivirine), suggests shifts toward less frequent dosing regimens, which may impact demand for traditional TDF/Emtricitabine FDCs.

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Future Outlook & Innovations

• Next-generation formulations, especially those with improved safety profiles these include TAF-based combinations and long-acting injectables, will dominate future markets.

• Personalized therapy approaches considering resistance profiles, comorbidities, and pharmacogenetics will become more prevalent.

• Global health initiatives will continue to drive accessibility in low-income settings, with patents expiring and generics reducing prices.

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Key Takeaways

• Clinical Rigor Supports Continued Use: Extensive clinical trials validate the efficacy and safety of Emtricitabine/TDF. Long-term safety data favor continued application, though emerging formulations aimed at reducing side effects are gaining traction.

• Market Dynamics Favor Transition to TAF: The safety advantages of TAF over TDF are prompting a shift, influencing product pipelines and market shares. Companies investing in TAF-based and novel long-acting formulations are well-positioned.

• Emerging Markets Present Growth Opportunities: Price sensitivity and increasing HIV prevalence in low- and middle-income countries sustain demand, especially for generics.

• Innovations Reshape Treatment Paradigms: Long-acting injectables and combination therapies integrating newer agents suggest a transformative future, potentially diminishing the prominence of traditional TDF/Emtricitabine regimens.

• Patent Expirations and Regulatory Approvals Will Influence Market Shares: Patent expiries open markets for generics, but branded innovations, especially in the TAF space, are poised to maintain or grow market dominance.

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FAQs

1. Will Emtricitabine and TDF remain a first-line treatment?
While still widely used, the integration of TAF-based formulations and long-acting injectables are likely to supplant traditional TDF/Emtricitabine regimens as the preferred first-line options due to safety advantages and improved adherence potential.

2. How do safety concerns influence market shifts?
TDF-associated renal impairment and bone density loss drive the transition toward TAF formulations globally, prompting manufacturers to develop and promote newer, safer options.

3. What role do emerging markets play in the future of this drug combination?
They are pivotal, driven by expanding access, government-led treatment programs, and the availability of affordable generics, which collectively sustain demand.

4. Are there ongoing efforts to develop long-acting formulations?
Yes, several clinical trials are evaluating long-acting injectable formulations that could replace daily oral regimens, potentially revolutionizing HIV treatment compliance.

5. What are the main risks to market stability?
Patent expiries, regulatory hurdles, and competition from new formulations or generics could alter the current market landscape significantly.

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References

1. UNAIDS. Global HIV & AIDS statistics — 2022.
2. IQVIA. Global HIV antivirals market report, 2022.
3. Gilead Sciences. Clinical trial registries and product pipeline updates.
4. ViiV Healthcare. Recent clinical data and pipeline insights.
5. World Health Organization. HIV treatment guidelines and safety profiles.

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By monitoring ongoing clinical trials, market shifts, and emerging formulations, stakeholders can strategically position themselves within this evolving landscape, ensuring optimal therapeutic choices and business growth.