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Last Updated: January 3, 2025

CLINICAL TRIALS PROFILE FOR EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE


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

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial TypeTrial IDTitleStatusSponsorPhaseStart DateSummary
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.
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.
>Trial Type>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 4 of 4 entries

All Clinical Trials for EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Trial IDTitleStatusSponsorPhaseStart DateSummary
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.
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.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 4 of 4 entries

Clinical Trial Conditions for EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Condition Name

662518130010203040506070HIV InfectionsHIVHIV-1 InfectionHIV Infection[disabled in preview]
Condition Name for EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Intervention Trials
HIV Infections 66
HIV 25
HIV-1 Infection 18
HIV Infection 13
[disabled in preview] 0
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Condition MeSH

1034125240-100102030405060708090100110HIV InfectionsAcquired Immunodeficiency SyndromeInfectionsImmunologic Deficiency Syndromes[disabled in preview]
Condition MeSH for EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Intervention Trials
HIV Infections 103
Acquired Immunodeficiency Syndrome 41
Infections 25
Immunologic Deficiency Syndromes 24
[disabled in preview] 0
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Clinical Trial Locations for EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Trials by Country

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Trials by Country for EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Location Trials
United States 907
Canada 86
Spain 52
United Kingdom 47
South Africa 45
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Trials by US State

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

Clinical Trial Phase

28.5%42.3%5.1%24.1%051015202530354045505560Phase 4Phase 3Phase 2/Phase 3[disabled in preview]
Clinical Trial Phase for EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Clinical Trial Phase Trials
Phase 4 39
Phase 3 58
Phase 2/Phase 3 7
[disabled in preview] 33
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Clinical Trial Status

79.1%7.4%7.4%6.1%0020406080100120140CompletedActive, not recruitingRecruiting[disabled in preview]
Clinical Trial Status for EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Clinical Trial Phase Trials
Completed 129
Active, not recruiting 12
Recruiting 12
[disabled in preview] 10
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Clinical Trial Sponsors for EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Sponsor Name

trials010203040506070Gilead SciencesNational Institute of Allergy and Infectious Diseases (NIAID)AIDS Clinical Trials Group[disabled in preview]
Sponsor Name for EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Sponsor Trials
Gilead Sciences 70
National Institute of Allergy and Infectious Diseases (NIAID) 44
AIDS Clinical Trials Group 12
[disabled in preview] 9
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Sponsor Type

50.0%33.6%16.1%0020406080100120140160180OtherIndustryNIH[disabled in preview]
Sponsor Type for EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Sponsor Trials
Other 177
Industry 119
NIH 57
[disabled in preview] 1
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EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE Market Analysis and Financial Projection

Emtricitabine and Tenofovir Disoproxil Fumarate: Clinical Trials, Market Analysis, and Projections

Clinical Trials Overview

Efficacy and Safety of Emtricitabine and Tenofovir Alafenamide vs. Emtricitabine and Tenofovir Disoproxil Fumarate

Recent clinical trials have compared the efficacy and safety of two antiretroviral regimens: emtricitabine and tenofovir alafenamide (TAF) versus emtricitabine and tenofovir disoproxil fumarate (TDF). The DISCOVER trial, a multinational, randomized controlled trial, enrolled 5387 participants who were randomly assigned to receive either emtricitabine and TAF or emtricitabine and TDF[1][4].

Key Findings

  • At 96 weeks of follow-up, emtricitabine and TAF demonstrated non-inferior efficacy to emtricitabine and TDF for HIV prevention, with incidence rates of 0.16 infections per 100 person-years for TAF and 0.30 infections per 100 person-years for TDF[1][4].
  • TAF showed improved bone mineral density and renal safety biomarkers compared to TDF, highlighting its safety profile for long-term use[1][4].

Long-Term Follow-Up

The extended follow-up period of 96 weeks in the DISCOVER trial provided valuable insights into the long-term efficacy and safety of these regimens. The results indicated that emtricitabine and TAF maintained its non-inferiority to emtricitabine and TDF, with a significant majority of participants (78-82%) reporting high adherence to the study medication[1].

ADVANCE Trial

Another significant trial, the ADVANCE trial, compared different antiretroviral regimens including those with tenofovir prodrugs. This trial evaluated the efficacy and safety of regimens combining tenofovir alafenamide (TAF) or tenofovir disoproxil fumarate (TDF) with emtricitabine and dolutegravir (DTG). The final 192-week results confirmed the high efficacy and safety of DTG-based regimens, although they noted substantial weight gain in participants[3].

Market Analysis

Market Size and Growth

The market for tenofovir disoproxil fumarate is projected to grow significantly over the coming years. According to market research, the global tenofovir disoproxil fumarate market is estimated to grow at a Compound Annual Growth Rate (CAGR) of around 4.5% from 2022 to 2027[2].

Market Drivers

Several factors are driving the growth of the tenofovir disoproxil fumarate market:

  • Growing Number of Hepatitis B Patients: The increasing prevalence of hepatitis B globally is a significant driver. According to the World Health Organization, 296 million people were living with chronic hepatitis B infection in 2019, leading to a higher demand for tenofovir disoproxil fumarate[2].
  • Increase in Female HIV Patients: Women are more vulnerable to HIV infection, and the growing awareness and efforts to prevent mother-to-child transmission of HIV have increased the use of tenofovir disoproxil fumarate among pregnant women[2].
  • Regional Growth: North America, particularly the United States, is a key region driving the market growth due to the presence of major pharmaceutical companies like Gilead Sciences Inc.[2].

Market Segmentation

The market is segmented based on various factors:

  • End User: The pregnant women segment holds a significant share and is expected to grow with a CAGR of 3.9% during the forecast period. Tenofovir disoproxil fumarate is recommended to prevent HIV transmission from mother to child during pregnancy and childbirth[2].
  • Route of Administration: The market includes oral and intravenous routes, with oral administration being the most common[5].
  • Indication: The drug is used for HIV pre-exposure prophylaxis (PrEP), HIV treatment, and hepatitis B virus infection[5].

Projections

Future Market Size

By 2032, the tenofovir disoproxil fumarate market is projected to reach USD 3.41 billion, growing at a CAGR of 6.41%[5].

Regional Projections

North America is expected to remain a leading region, driven by the high prevalence of HIV and hepatitis B, as well as the presence of major pharmaceutical companies. Other regions, including Europe, Asia Pacific, and South America, are also expected to contribute significantly to the market growth[5].

Generic Availability

The availability of tenofovir disoproxil fumarate as a generic medication is expected to increase its accessibility and affordability, further boosting market growth. Generic production, especially in regions with high disease prevalence, will play a crucial role in expanding the market[2].

Side Effects and Safety Considerations

While tenofovir disoproxil fumarate is effective, it is not without side effects. Common adverse effects include nausea, rash, diarrhea, headache, pain, and depression. These side effects can restrict its usage in some cases[2].

Key Takeaways

  • Clinical Efficacy: Emtricitabine and tenofovir alafenamide have been shown to be non-inferior to emtricitabine and tenofovir disoproxil fumarate for HIV prevention, with improved safety profiles.
  • Market Growth: The tenofovir disoproxil fumarate market is expected to grow significantly, driven by increasing cases of HIV and hepatitis B, and the growing need for antiretroviral therapy.
  • Regional Impact: North America, particularly the U.S., will continue to be a major driver of market growth due to the presence of key pharmaceutical companies.
  • Generic Availability: The availability of generic tenofovir disoproxil fumarate will increase accessibility and affordability, contributing to market expansion.

FAQs

Q: What are the primary uses of tenofovir disoproxil fumarate?

A: Tenofovir disoproxil fumarate is used for the treatment of chronic hepatitis B and for the prevention and treatment of HIV/AIDS[2].

Q: How does tenofovir disoproxil fumarate compare to tenofovir alafenamide in terms of safety and efficacy?

A: Tenofovir alafenamide has shown improved renal and bone safety compared to tenofovir disoproxil fumarate, while maintaining non-inferior efficacy for HIV prevention[1][4].

Q: What are the common side effects of tenofovir disoproxil fumarate?

A: Common side effects include nausea, rash, diarrhea, headache, pain, and depression[2].

Q: Which regions are expected to drive the growth of the tenofovir disoproxil fumarate market?

A: North America, particularly the U.S., and other regions such as Europe, Asia Pacific, and South America are expected to drive market growth[5].

Q: What is the projected market size of tenofovir disoproxil fumarate by 2032?

A: The market is projected to reach USD 3.41 billion by 2032, growing at a CAGR of 6.41%[5].

Sources

  1. Long-term safety and efficacy of emtricitabine and tenofovir alafenamide... - PubMed
  2. Tenofovir Disoproxil Fumarate Market Size Report, 2022-2027 - IndustryArc
  3. Final 192-Week Efficacy and Safety Results of the ADVANCE Trial... - Oxford Academic
  4. Primary results from a randomised, double-blind, multicentre, active... - PubMed
  5. Tenofovir Disoproxil Fumarate Market Growth Analysis 2032 | MRFR - Market Research Future

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