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Last Updated: February 14, 2025

CLINICAL TRIALS PROFILE FOR COMBIVIR


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All Clinical Trials for Combivir

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000887 ↗ A Study to Evaluate the Safety and Tolerance of Nelfinavir (NFV) Given With Zidovudine (ZDV) and Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 1 1969-12-31 The purpose of this study is to see if giving nelfinavir (NFV) plus zidovudine (ZDV) plus lamivudine (3TC) to HIV-positive pregnant women and their babies is safe. This study will also look at how long these drugs stay in the blood. ZDV has been given to mothers in the past to reduce the chances of passing HIV on to their babies. However, better treatments are needed to further reduce these chances and to better suit the treatment needs of mothers and their children. Taking a combination of anti-HIV drugs during pregnancy may be an answer.
NCT00000887 ↗ A Study to Evaluate the Safety and Tolerance of Nelfinavir (NFV) Given With Zidovudine (ZDV) and Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 1969-12-31 The purpose of this study is to see if giving nelfinavir (NFV) plus zidovudine (ZDV) plus lamivudine (3TC) to HIV-positive pregnant women and their babies is safe. This study will also look at how long these drugs stay in the blood. ZDV has been given to mothers in the past to reduce the chances of passing HIV on to their babies. However, better treatments are needed to further reduce these chances and to better suit the treatment needs of mothers and their children. Taking a combination of anti-HIV drugs during pregnancy may be an answer.
NCT00000888 ↗ Safety and Effectiveness of Ritonavir Plus Lamivudine Plus Zidovudine in HIV-Infected Pregnant Women and Their Babies Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 1 1969-12-31 The purpose of this study is to see if it is safe and effective to give ritonavir (RTV) plus lamivudine (3TC) plus zidovudine (ZDV) to HIV-infected pregnant women during pregnancy and to their babies after birth. Pregnant women who are HIV-positive are at risk of giving HIV to their babies during pregnancy or delivery. It is important to learn how to prevent HIV-positive pregnant women from giving HIV to their babies. RTV and ZDV have been shown to be safe and effective against HIV in adults. The combination of 3 anti-HIV drugs (RTV, 3TC, and ZDV) may help prevent HIV infection from mother to infant but studies are needed to determine whether they are safe and effective during pregnancy.
NCT00000888 ↗ Safety and Effectiveness of Ritonavir Plus Lamivudine Plus Zidovudine in HIV-Infected Pregnant Women and Their Babies Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 1969-12-31 The purpose of this study is to see if it is safe and effective to give ritonavir (RTV) plus lamivudine (3TC) plus zidovudine (ZDV) to HIV-infected pregnant women during pregnancy and to their babies after birth. Pregnant women who are HIV-positive are at risk of giving HIV to their babies during pregnancy or delivery. It is important to learn how to prevent HIV-positive pregnant women from giving HIV to their babies. RTV and ZDV have been shown to be safe and effective against HIV in adults. The combination of 3 anti-HIV drugs (RTV, 3TC, and ZDV) may help prevent HIV infection from mother to infant but studies are needed to determine whether they are safe and effective during pregnancy.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Combivir

Condition Name

Condition Name for Combivir
Intervention Trials
HIV Infections 42
HIV Infection 8
Pregnancy 5
HIV 5
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Condition MeSH

Condition MeSH for Combivir
Intervention Trials
HIV Infections 53
Acquired Immunodeficiency Syndrome 12
Infections 10
Infection 7
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Clinical Trial Locations for Combivir

Trials by Country

Trials by Country for Combivir
Location Trials
United States 277
Spain 23
Canada 18
United Kingdom 11
South Africa 10
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Trials by US State

Trials by US State for Combivir
Location Trials
California 29
Florida 20
New York 17
Pennsylvania 16
Texas 14
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Clinical Trial Progress for Combivir

Clinical Trial Phase

Clinical Trial Phase for Combivir
Clinical Trial Phase Trials
Phase 4 21
Phase 3 16
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Combivir
Clinical Trial Phase Trials
Completed 52
Unknown status 4
Withdrawn 2
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Clinical Trial Sponsors for Combivir

Sponsor Name

Sponsor Name for Combivir
Sponsor Trials
National Institute of Allergy and Infectious Diseases (NIAID) 12
Glaxo Wellcome 10
GlaxoSmithKline 8
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Sponsor Type

Sponsor Type for Combivir
Sponsor Trials
Industry 50
Other 36
NIH 22
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Combivir: Clinical Trials, Market Analysis, and Projections

Introduction to Combivir

Combivir is an antiretroviral medication that combines two active ingredients: lamivudine and zidovudine. It is used in the treatment of HIV-1 infection, often in combination with other antiretroviral agents. Here, we will delve into the current clinical trials, market analysis, and future projections for Combivir.

Clinical Trials and Development

While Combivir itself is an established drug, the landscape of HIV treatment is continuously evolving with new clinical trials and developments.

Current HIV Treatment Landscape

Recent clinical trials have focused on newer, more convenient treatment regimens. For example, Merck and Gilead are advancing a once-weekly oral combination regimen of islatravir and lenacapavir, which has shown promising results in maintaining viral suppression in adults with HIV-1[4].

However, Combivir, as a combination of lamivudine and zidovudine, has been a staple in HIV treatment for many years. Its efficacy and safety profile have been well-established through numerous clinical trials.

Generic and Branded Versions

The introduction of generic versions of Combivir has significantly impacted the market. In 2011, Teva launched a generic version of Combivir in the US market, which has contributed to the growth of the generic antiviral market[2].

Market Analysis

Current Market Size and Growth

The global Combivir market is expected to grow at a moderate rate. As of 2022, the market was valued at a significant amount and is projected to grow at a CAGR of around 3% during the forecast period of 2023-2030[3].

Driving Factors

Several factors are driving the growth of the Combivir market:

  • Increased Awareness and Investments: Government awareness programs and increased investments in healthcare departments have boosted the demand for HIV treatments[3].
  • Drug Addiction and HIV Prevalence: A surge in drug addiction among adults and adolescents, particularly in regions like Asia-Pacific, has increased the incidence of HIV, thereby driving the demand for antiretroviral drugs like Combivir[3].
  • Generic Market Expansion: The generic market, which includes products like Combivir, is expected to grow significantly due to patent expiries of branded antiviral drugs[2].

Regional Market

The Combivir market is analyzed based on its presence in various regions:

  • North America: This region is expected to dominate the market during the forecast period due to high awareness and advanced healthcare infrastructure[3].
  • Asia-Pacific: This region is expected to grow with a high CAGR due to increasing drug addiction and government initiatives to combat HIV/AIDS[3].

Market Projections

Generic vs. Branded Market

The generic segment of the Combivir market is expected to continue growing, driven by the expiration of patents for key antiviral drugs. By 2018, generics were forecast to account for 29.2% of the global antivirals market, up from 18.9% in 2010[2].

Emerging Trends

  • Cost-Effective Generics: The production of cost-effective generics with high efficacy is an emerging trend in the Combivir market. This trend is expected to continue as more patents expire and generic manufacturers seize the opportunity to produce affordable alternatives[3].
  • Government Policies: Regulatory changes and financial incentives from Pharmacy Benefit Managers (PBMs) for dispensing generic drugs are also driving the growth of the generic market[2].

Competitive Landscape

The HIV therapeutics market is highly competitive, with several major players:

  • Gilead Sciences: Known for its innovative antiretroviral therapies, including single-tablet regimens like Genvoya and Descovy[5].
  • ViiV Healthcare: Offers a range of antiretroviral therapies, including integrase inhibitors and long-acting injectable formulations[5].
  • Merck & Co.: Continues to develop new antiretroviral agents, such as islatravir, which is being evaluated in various clinical trials[1][4].

Key Takeaways

  • Moderate Growth: The Combivir market is expected to grow at a moderate rate of around 3% during the forecast period.
  • Generic Expansion: The generic segment is driving market growth due to patent expiries and increased demand for affordable antiretroviral drugs.
  • Regional Dominance: North America is expected to dominate the market, while Asia-Pacific is expected to grow rapidly.
  • Emerging Trends: Cost-effective generics and favorable government policies are key trends shaping the market.

FAQs

Q1: What is the current market size and growth potential of the Combivir market?

The Combivir market was valued at USD XX million in 2022 and is expected to grow at a CAGR of around 3% during the forecast period (2023-2030)[3].

Q2: What are the driving factors for the growth of the Combivir market?

Increased drug addiction, surge in awareness programs regarding HIV/AIDS, and rising investments in healthcare departments are the driving factors for the growth of the Combivir market[3].

Q3: Which segment has the largest share of the Combivir market by type?

The branded segment currently has the largest share, but the generic segment is growing rapidly due to patent expiries and cost-effectiveness[3].

Q4: What are the emerging technologies and trends in the Combivir market?

Production of cost-effective generics with high efficacy and favorable government policies are emerging trends in the Combivir market[3].

Q5: Which region will dominate the Combivir market?

North America is expected to dominate the market during the forecast period, while Asia-Pacific is expected to grow with a high CAGR[3].

Sources

  1. Merck Provides Update on Phase 2 Clinical Trial of Once-Weekly Investigational Combination of MK-8507 and Islatravir for the Treatment of People Living with HIV-1 - Merck News.
  2. HIV Generics Take Over the Antivirals Market - Fierce Pharma.
  3. Combivir Market: Current Analysis and Forecast (2023-2030) - UnivDatos.
  4. Gilead and Merck Announce Phase 2 Data Showing a Treatment Switch to an Investigational Oral Once-Weekly Combination Regimen of Islatravir and Lenacapavir Maintained Viral Suppression in Adults at Week 48 - Merck News.
  5. Global Drug Forecast and Market Analysis to 2025 - GlobalData.

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