CLINICAL TRIALS PROFILE FOR ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE

All Clinical Trials for abacavir sulfate; lamivudine; zidovudine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00270296 ↗	Trizivir Vs. Kaletra and Combivir for the Prevention of Mother-to-Child Transmission of HIV	Completed	Harvard School of Public Health	Phase 2	2006-06-01	Anti-HIV drug regimens have dramatically improved the rates of prevention of mother-to-child transmission (MTCT) of HIV in developed countries. However, little is known of the effectiveness of such regimens in developing countries, such as Botswana. This study will determine whether Trizivir (TZV), a single pill containing abacavir sulfate, lamivudine, and zidovudine (ABC/3TC/ZDV), or lopinavir/ritonavir (LPV/r) and lamivudine/zidovudine (3TC/ZDV) is more effective in reducing HIV-1 viral load and preventing MTCT among HIV infected pregnant women in Botswana.
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.
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.

Clinical Trial Conditions for abacavir sulfate; lamivudine; zidovudine

Condition Name

Condition Name for abacavir sulfate; lamivudine; zidovudine
Intervention	Trials
HIV Infections	5
HIV Infection	1
Tuberculosis	1

Condition MeSH

Condition MeSH for abacavir sulfate; lamivudine; zidovudine
Intervention	Trials
HIV Infections	6
Acquired Immunodeficiency Syndrome	2
Infections	2
Infection	2

Clinical Trial Locations for abacavir sulfate; lamivudine; zidovudine

Trials by Country

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Trials by Country for abacavir sulfate; lamivudine; zidovudine
Location	Trials
United States	29
Canada	5
Mexico	4
Italy	1
Puerto Rico	1

Trials by US State

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−

Trials by US State for abacavir sulfate; lamivudine; zidovudine
Location	Trials
New York	3
North Carolina	2
Illinois	2
Ohio	2
Georgia	1

Clinical Trial Progress for abacavir sulfate; lamivudine; zidovudine

Clinical Trial Phase

Clinical Trial Phase for abacavir sulfate; lamivudine; zidovudine
Clinical Trial Phase	Trials
Phase 3	3
Phase 2	3

Clinical Trial Status

Clinical Trial Status for abacavir sulfate; lamivudine; zidovudine
Clinical Trial Phase	Trials
Completed	6

Clinical Trial Sponsors for abacavir sulfate; lamivudine; zidovudine

Sponsor Name

Sponsor Name for abacavir sulfate; lamivudine; zidovudine
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	5
Makerere University	1
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	1

Sponsor Type

Sponsor Type for abacavir sulfate; lamivudine; zidovudine
Sponsor	Trials
NIH	6
Other	3
Industry	1

Clinical Trials, Market Analysis, and Projections for Abacavir Sulfate, Lamivudine, and Zidovudine

Introduction

Abacavir sulfate, lamivudine, and zidovudine are antiretroviral medications commonly used in combination for the treatment of HIV-1 infection. This article provides an update on clinical trials, market analysis, and projections for these drugs.

Clinical Trials Update

Ongoing and Completed Trials

Clinical trials involving abacavir sulfate, lamivudine, and zidovudine have been extensive and ongoing. These trials often combine these drugs with other antiretrovirals to assess efficacy and safety.

• Combination Therapies: Studies have shown that abacavir, when combined with lamivudine and zidovudine, exhibits synergistic or additive activity with other antiretroviral agents such as zidovudine, nevirapine, and amprenavir[1].
• Phase 3 Trials: Several Phase 3 trials have been conducted, comparing different combinations of antiretroviral drugs. For example, trials have evaluated the efficacy of regimens including abacavir sulfate, lamivudine, zidovudine, and other drugs like lopinavir/ritonavir and efavirenz[4].

Safety and Efficacy

Clinical trials have highlighted the safety and efficacy profile of these drugs. However, they also note potential adverse reactions and precautions.

• Hypersensitivity Reactions: Abacavir is associated with potentially life-threatening hypersensitivity reactions, which must be closely monitored and managed[5].
• Adverse Reactions: Common adverse reactions include drug hypersensitivity, insomnia, depression, headache, fatigue, dizziness, nausea, and diarrhea[3].

Market Analysis

Global Sales and Price Analysis

The market for abacavir, lamivudine, and zidovudine is significant, with sales data available for various regions.

• Sales by Region: Sales data for these drugs are tracked globally, including in North America, Europe, Japan, BRIC countries, and Australia. Reports provide detailed sales figures and trends by country[2].
• Price Analysis: The unit price of these drugs varies by country, and market research provides benchmarks and trends in pricing, which are crucial for brand planning and competitive intelligence[2].

Market Trends and Forecasts

Market trends indicate a steady demand for these antiretroviral drugs due to the ongoing need for effective HIV treatment.

• Sales Forecast: Sales forecasts until 2021 and beyond have been provided in market research reports, indicating continued growth in the market for these combination therapies[2].
• Generic Trends: The market also sees the impact of generic versions of these drugs, which can affect pricing and market dynamics[2].

Market Projections

Growth Prospects

The market for abacavir, lamivudine, and zidovudine is expected to continue growing due to several factors.

• Increasing HIV Prevalence: The ongoing global HIV epidemic ensures a sustained demand for effective antiretroviral therapies.
• Advancements in Treatment: Continuous advancements in antiretroviral therapy, including combination products like TRIZIVIR (abacavir, lamivudine, and zidovudine), contribute to market growth[5].

Competitive Landscape

The competitive landscape for these drugs involves several key players and a mix of branded and generic products.

• Key Players: Companies such as ViiV Healthcare are major players in the market, offering branded and combination products[5].
• Generic Competition: Generic versions of these drugs are available, influencing market dynamics and pricing strategies[2].

Dosage and Administration

Understanding the dosage and administration of these drugs is crucial for their effective use.

• Combination Products: TRIZIVIR, for example, is a fixed-dose combination product containing 300 mg of abacavir, 150 mg of lamivudine, and 300 mg of zidovudine per tablet. This product is not suitable for children weighing less than 40 kg due to its fixed dose[5].
• Dosage Adjustments: Dosage adjustments are necessary for patients with renal impairment or other specific conditions. For instance, the dose frequency of lamivudine may need to be reduced in patients with moderate to severe renal impairment[5].

Special Considerations

Hepatic Function

Monitoring hepatic function is important, especially when initiating anti-hepatitis B treatment in patients receiving abacavir and lamivudine[3].

Pregnancy and Lactation

The use of abacavir, lamivudine, and zidovudine in pregnancy should be carefully considered, weighing the potential benefits against the risks. These drugs have been evaluated in the Antiretroviral Pregnancy Registry, but their safe use in human pregnancy has not been established in well-controlled trials[5].

Adverse Reactions and Precautions

Hypersensitivity Reactions

Abacavir is known for its association with severe hypersensitivity reactions, which can be life-threatening. These reactions must be recognized and managed promptly[5].

Other Adverse Reactions

Other common adverse reactions include insomnia, depression, headache, fatigue, dizziness, nausea, and diarrhea. Pancreatitis is a concern, especially in pediatric patients with a history of pancreatitis or significant risk factors[3].

Key Takeaways

• Clinical Trials: Ongoing and completed trials have established the efficacy and safety of abacavir, lamivudine, and zidovudine in combination therapies.
• Market Analysis: The global market for these drugs shows steady growth, with significant sales and pricing trends across various regions.
• Market Projections: The market is expected to continue growing due to the ongoing need for effective HIV treatments and advancements in antiretroviral therapy.
• Dosage and Administration: Careful consideration of dosage and administration is necessary, especially for patients with specific conditions like renal impairment.
• Special Considerations: Monitoring hepatic function and careful use in pregnancy are important considerations.

FAQs

Q: What is the primary use of abacavir sulfate, lamivudine, and zidovudine?

A: These drugs are used in combination with other antiretrovirals for the treatment of HIV-1 infection.

Q: What are the common adverse reactions associated with these drugs?

A: Common adverse reactions include drug hypersensitivity, insomnia, depression, headache, fatigue, dizziness, nausea, and diarrhea.

Q: Can TRIZIVIR be used in children?

A: TRIZIVIR should not be administered to children and adolescents who weigh less than 40 kg due to its fixed-dose combination.

Q: How do these drugs interact with other medications?

A: Clinical studies have shown no clinically significant interactions between abacavir, zidovudine, and lamivudine, but caution is advised with certain other medications like aciclovir[5].

Q: What are the precautions for using these drugs in pregnancy?

A: The use of abacavir, lamivudine, and zidovudine in pregnancy should be carefully considered, weighing the potential benefits against the risks, as their safe use in human pregnancy has not been established in well-controlled trials[5].

Sources

1. DrugBank Online: Abacavir: Uses, Interactions, Mechanism of Action.
2. Business Wire: Global Abacavir / Lamivudine / Zidovudine Sales, Price Analysis, & Sales Forecast - 2017.
3. FDA: Abacavir sulfate and Lamivudine tablets 60/30 mg.
4. Synapse: Abacavir Sulfate - Drug Targets, Indications, Patents.
5. ViiV Healthcare: TRIZIVIR (abacavir, lamivudine and zidovudine) film-coated tablets.