CLINICAL TRIALS PROFILE FOR ZIAGEN

All Clinical Trials for ZIAGEN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00085943 ↗	KALETRA Or LEXIVA With Ritonavir Combined With EPIVIR And Abacavir In Naive Subjects Over 48 Weeks	Completed	GlaxoSmithKline	Phase 3	2004-05-01	This study will compare the ability of fosamprenavir 700 mg with ritonavir 100 mg twice a day or lopinavir 400 mg with ritonavir 100 mg twice a day both combined with a fixed dose combination tablet of abacavir 600 mg and lamivudine 300 mg once a day to suppress virus levels of HIV to less than 400 copies/mL of blood. In addition we will study the safety and tolerability of these compounds over the 48 week study period in patients naive to anti-HIV therapy.
NCT00038506 ↗	Study Of Investigational Regimen Combining FDA Approved HIV Drugs In HIV Subjects Experiencing Early Virologic Failure	Completed	ViiV Healthcare	Phase 4	2002-03-01	This study is a 48-week study to evaluate the efficacy and safety of an investigational regimen combining FDA approved HIV drugs in antiretroviral-experienced subjects failing on their first highly active antiretroviral therapy regimen.
NCT00004585 ↗	A Study of the Safety and Effectiveness of Combination Anti-HIV Therapy in HIV-Infected Adults	Completed	Glaxo Wellcome	Phase 4	1999-10-01	The purpose of this study is to see if a certain combination of anti-HIV drugs is safe and effective in HIV-infected patients. The drug combination includes a tablet containing lamivudine and zidovudine (called Combivir) plus abacavir plus efavirenz.
NCT00004981 ↗	Safety and Effectiveness of Three Anti-HIV Drugs Combined in One Pill (Trizivir)	Unknown status	Glaxo Wellcome	Phase 3	1969-12-31	The purpose of this study is to look at the safety and effectiveness of a pill called Trizivir that is a combination of three anti-HIV drugs (zidovudine, lamivudine, and abacavir). Zidovudine and lamivudine are often given combined in one pill (Combivir). In this study, Trizivir will be compared to Combivir plus abacavir.
NCT00005017 ↗	Effectiveness and Safety of Epivir/Ziagen/Zerit (3TC/ABC/d4T) Versus Epivir/Ziagen/Sustiva (3TC/ABC/EFV) Versus Epivir/Ziagen/Agenerase/Norvir (3TC/ABC/APV/RTV) in HIV Patients Who Have Never Received Treatment	Unknown status	Glaxo Wellcome	Phase 4	1969-12-31	The purpose of this study is to see how effective and safe it is to give 1 of the 3 following treatments to patients who may not have received anti-HIV treatment: 1) lamivudine (3TC)/abacavir (ABC)/stavudine (d4T); 2) 3TC/ABC/efavirenz (EFV); or 3) 3TC/ABC/amprenavir (APV)/ritonavir (RTV).

Clinical Trial Conditions for ZIAGEN

Condition Name

Condition Name for ZIAGEN
Intervention	Trials
HIV Infections	7
HIV	3
HIV Infection	2
Infection, Human Immunodeficiency Virus	1

Condition MeSH

Condition MeSH for ZIAGEN
Intervention	Trials
HIV Infections	10
Infections	4
Infection	4
Acquired Immunodeficiency Syndrome	3

Clinical Trial Locations for ZIAGEN

Trials by Country

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Trials by Country for ZIAGEN
Location	Trials
United States	60
Germany	4
Canada	3
Italy	3
Switzerland	2

Trials by US State

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−

Trials by US State for ZIAGEN
Location	Trials
New York	5
California	5
Florida	4
Texas	4
Maryland	3

Clinical Trial Progress for ZIAGEN

Clinical Trial Phase

Clinical Trial Phase for ZIAGEN
Clinical Trial Phase	Trials
Phase 4	6
Phase 3	4
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for ZIAGEN
Clinical Trial Phase	Trials
Completed	11
Unknown status	2
Recruiting	1

Clinical Trial Sponsors for ZIAGEN

Sponsor Name

Sponsor Name for ZIAGEN
Sponsor	Trials
Glaxo Wellcome	3
GlaxoSmithKline	3
ViiV Healthcare	2

Sponsor Type

Sponsor Type for ZIAGEN
Sponsor	Trials
Other	12
Industry	9
NIH	4

ZIAGEN (Abacavir): Clinical Trials, Market Analysis, and Projections

Introduction

ZIAGEN, known generically as abacavir, is an antiretroviral medication used in the treatment of HIV-1 infection. Here, we will delve into the clinical trials, market analysis, and projections for this drug.

Clinical Trials and Efficacy

Key Studies

ZIAGEN has been extensively studied in various clinical trials to establish its efficacy and safety profile. One of the pivotal studies is the CNA30021 or Zodiac trial, which compared the once-daily dosing of abacavir (ABC) with the twice-daily dosing, both in combination with lamivudine (3TC) and efavirenz (EFV)[3].

• Zodiac Trial: This randomized, double-blind trial involved 770 treatment-naive patients and demonstrated that once-daily abacavir had a similar antiviral effect to twice-daily dosing. The study showed that the once-daily regimen was non-inferior to the twice-daily regimen in achieving HIV-1 RNA levels below 50 copies/mL[3].

Safety Profile

While the efficacy of ZIAGEN is well-established, its safety profile includes several notable points:

• Hypersensitivity Reaction (HSR): One of the significant adverse effects associated with abacavir is the hypersensitivity reaction, which has been reported in approximately 9% of patients in the Zodiac trial. This reaction can be severe and requires careful monitoring and patient education[3].
• Other Adverse Effects: Common adverse effects include nausea, headache, malaise/fatigue, diarrhea, vomiting, rash, and fever. The incidence of these side effects is significant, with 62% to 65% of patients reporting grade 2 or greater adverse events[3].

Market Analysis

Market Size and Growth

The antiretroviral therapy market, which includes ZIAGEN, is projected to grow significantly. As of 2018, the global antiretroviral therapy market was valued at $24.48 billion and is expected to reach $33.83 billion by 2025, growing at a CAGR of 4.73%[2].

Regional Market

The market for antiretroviral therapies, including ZIAGEN, varies by region. In Africa, the consumption of antiretroviral drugs is increasing due to the growing number of HIV cases and initiatives by international bodies such as the WHO. Generic drugs, which include abacavir, account for a significant share of the market, especially in low-income countries[2].

Competitive Landscape

ZIAGEN operates in a competitive market with other antiretroviral drugs. The combination of abacavir with lamivudine, known as Epzicom, competes with other fixed-dose combinations (FDCs) and single-agent therapies. The market is driven by the need for effective and tolerable treatments, with factors such as efficacy, safety, and patient compliance playing crucial roles[3].

Market Projections

Generic Availability

The generic availability of abacavir is expected to impact the market significantly. Generic versions of ZIAGEN have been approved, which could lead to increased competition and potentially lower prices. This could expand access to the drug, especially in regions where affordability is a concern[5].

Pricing Dynamics

The pricing of antiretroviral drugs, including generic abacavir, varies widely across different regions. In sub-Saharan Africa, generic drugs are generally cheaper, while in lower-middle and upper-middle-income countries, prices are higher. This pricing dynamic affects the market growth and accessibility of the drug[2].

Regulatory Environment

FDA Approval and Monitoring

ZIAGEN was approved by the FDA in 1998, and since then, it has been subject to ongoing monitoring. The FDA requires careful education programs for both doctors and patients, particularly regarding the hypersensitivity reaction associated with abacavir. This regulatory oversight ensures that the drug is used safely and effectively[3][5].

Expert Recommendations and Guidelines

International Antiviral Society-USA Guidelines

The International Antiviral Society-USA provides updated recommendations for HIV treatment. While abacavir is not the first-line recommendation in all cases, it remains a viable option, especially in combination with other antiretroviral drugs. For example, the combination of abacavir with lamivudine and other agents is considered for certain patient populations[4].

Key Takeaways

• Clinical Efficacy: ZIAGEN has demonstrated efficacy in clinical trials, particularly in the Zodiac study.
• Safety Concerns: The drug is associated with a significant hypersensitivity reaction and other adverse effects.
• Market Growth: The antiretroviral therapy market is projected to grow, driven by increasing HIV cases and generic availability.
• Regulatory Environment: FDA approval and ongoing monitoring are crucial for the safe use of ZIAGEN.
• Expert Recommendations: ZIAGEN remains a part of HIV treatment guidelines, especially in combination therapies.

FAQs

What is ZIAGEN used for?

ZIAGEN (abacavir) is used in the treatment of HIV-1 infection, often in combination with other antiretroviral drugs.

What are the common side effects of ZIAGEN?

Common side effects include hypersensitivity reaction, nausea, headache, malaise/fatigue, diarrhea, vomiting, rash, and fever.

Is ZIAGEN available in generic form?

Yes, generic versions of abacavir have been approved and are available in the market.

How does the pricing of ZIAGEN vary globally?

Pricing varies significantly across regions, with generic versions generally being cheaper in low-income countries and more expensive in lower-middle and upper-middle-income countries.

What are the current market projections for antiretroviral therapies like ZIAGEN?

The global antiretroviral therapy market is expected to reach $33.83 billion by 2025, growing at a CAGR of 4.73%.

Sources

1. CITELINE.COM - Key Potential Drug Launches in 2025 (As of July 2024)
2. Brandessence Research - Antiretroviral Therapy Market Size, Scope, Trends and Forecast 2029
3. Treatment Action Group - Epzicom Brand Abacavir-Lamivudine QD
4. JAMA Network - Antiretroviral Drugs for Treatment and Prevention of HIV in Adults
5. Drugs.com - Generic Ziagen Availability