CLINICAL TRIALS PROFILE FOR ABACAVIR SULFATE; LAMIVUDINE

All Clinical Trials for Abacavir Sulfate; Lamivudine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.

Clinical Trial Conditions for Abacavir Sulfate; Lamivudine

Condition Name

Condition Name for Abacavir Sulfate; Lamivudine
Intervention	Trials
HIV Infections	5
HIV Infection	2
Infection, Human Immunodeficiency Virus	1
Tuberculosis	1

Condition MeSH

Condition MeSH for Abacavir Sulfate; Lamivudine
Intervention	Trials
HIV Infections	8
Acquired Immunodeficiency Syndrome	3
Infection	2
Communicable Diseases	2

Clinical Trial Locations for Abacavir Sulfate; Lamivudine

Trials by Country

Trials by Country for Abacavir Sulfate; Lamivudine
Location	Trials
United States	48
Canada	5
Mexico	4
Puerto Rico	2
Botswana	1

Trials by US State

Trials by US State for Abacavir Sulfate; Lamivudine
Location	Trials
New York	4
North Carolina	3
Illinois	3
Texas	2
New Jersey	2

Clinical Trial Progress for Abacavir Sulfate; Lamivudine

Clinical Trial Phase

Clinical Trial Phase for Abacavir Sulfate; Lamivudine
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	3
Phase 2	3

Clinical Trial Status

Clinical Trial Status for Abacavir Sulfate; Lamivudine
Clinical Trial Phase	Trials
Completed	8

Clinical Trial Sponsors for Abacavir Sulfate; Lamivudine

Sponsor Name

Sponsor Name for Abacavir Sulfate; Lamivudine
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	5
GlaxoSmithKline	2
Harvard School of Public Health (HSPH)	1

Sponsor Type

Sponsor Type for Abacavir Sulfate; Lamivudine
Sponsor	Trials
NIH	6
Industry	4
Other	3

Abacavir Sulfate and Lamivudine: Clinical Trials, Market Analysis, and Projections

Introduction

Abacavir sulfate and lamivudine, combined in a single tablet, are nucleoside analogue HIV-1 reverse transcriptase inhibitors used in the treatment of HIV-1 infection. This article provides an update on the clinical trials, market analysis, and projections for this drug combination.

Clinical Trials Overview

Adult Clinical Trials

Clinical trials involving abacavir sulfate and lamivudine have demonstrated their efficacy and safety in treating HIV-1 infection in adults. These trials often compare the combination therapy with other antiretroviral regimens. For instance, the SINGLE study (ING114467) compared the efficacy and safety of a fixed-dose combination of abacavir, lamivudine, and another antiretroviral agent (dolutegravir) with the combination of efavirenz, tenofovir, and emtricitabine over 48 and 96 weeks. The results showed comparable antiviral activity and tolerability between the two regimens[3].

Pediatric Clinical Trials

The ARROW trial assessed the safety and efficacy of once-daily versus twice-daily dosing of abacavir and lamivudine in pediatric patients. The study found that once-daily dosing was non-inferior to twice-daily dosing, with similar rates of adverse events and viral suppression[2].

Hypersensitivity Reactions

A significant aspect of clinical trials has been the monitoring of hypersensitivity reactions, which are a known risk associated with abacavir. Studies have emphasized the importance of screening for the HLA-B5701 allele before initiating therapy to reduce the risk of these reactions. For example, the CNA106030 (PREDICT-1) study evaluated the clinical utility of prospective HLA-B5701 screening and found it to be effective in reducing the incidence of abacavir hypersensitivity reactions[4].

Market Analysis

Market Indications

Abacavir sulfate and lamivudine are indicated for the treatment of HIV-1 infection in combination with other antiretroviral agents. This combination is marketed under various brand names, including Epzicom (Kivexa in some regions), and is available in a fixed-dose tablet formulation[1][3][4].

Market Competition

The HIV treatment market is highly competitive, with numerous antiretroviral therapies available. However, the combination of abacavir and lamivudine remains a significant player due to its efficacy, convenience of once-daily dosing, and the comprehensive data from clinical trials supporting its use.

Regulatory Approvals

The drug combination has received regulatory approvals in various regions, including the European Economic Area and the United States. For example, the European Medicines Agency approved Abacavir/Lamivudine Amarox, a generic version of Kivexa, based on bioequivalence studies[5].

Market Projections

Growing Demand for HIV Treatments

The global demand for HIV treatments is expected to grow due to the increasing prevalence of HIV and the need for effective antiretroviral therapies. According to market projections, the HIV treatment market is anticipated to expand significantly over the next decade, driven by advancements in treatment options and increased access to healthcare in developing regions.

Generic Competition

The entry of generic versions, such as Abacavir/Lamivudine Amarox, is expected to increase market competition and potentially reduce the market share of branded products. However, the established brand reputation and the comprehensive clinical data supporting the use of Epzicom/Kivexa are likely to maintain its market presence[5].

Emerging Markets

Emerging markets, particularly in Africa and Asia, are expected to play a crucial role in the future growth of the HIV treatment market. Initiatives to improve access to antiretroviral therapies in these regions will likely drive the demand for affordable and effective treatments like abacavir sulfate and lamivudine.

Safety and Efficacy Considerations

Hypersensitivity Reactions

The risk of hypersensitivity reactions remains a critical safety consideration. Screening for the HLA-B*5701 allele is mandatory before initiating therapy to mitigate this risk. Patients with a history of hypersensitivity to abacavir must not be re-exposed to the drug[1][3][4].

Hepatitis B Co-infection

Patients co-infected with hepatitis B require close monitoring of hepatic function, and initiation of anti-hepatitis B therapy may be necessary. This is due to the potential for exacerbations of hepatitis B upon discontinuation of the antiretroviral therapy[1][4].

Adverse Reactions

Common adverse reactions include drug hypersensitivity, insomnia, depression, headache, fatigue, dizziness, nausea, and diarrhea. Serious adverse reactions such as lactic acidosis and severe hepatomegaly have also been reported[1][4].

Key Takeaways

• Clinical Efficacy: Abacavir sulfate and lamivudine have demonstrated efficacy in treating HIV-1 infection in both adults and pediatric patients.
• Safety Considerations: Screening for HLA-B*5701 allele and monitoring for hypersensitivity reactions and hepatic function are crucial.
• Market Competition: The market is competitive, but the combination remains a significant player due to its once-daily dosing and comprehensive clinical data.
• Market Projections: Growing demand in emerging markets and the entry of generic versions will shape the future market landscape.

FAQs

Q: What is the primary indication for abacavir sulfate and lamivudine?

A: Abacavir sulfate and lamivudine are indicated for the treatment of HIV-1 infection in combination with other antiretroviral agents.

Q: Why is HLA-B*5701 allele screening important before starting abacavir sulfate and lamivudine?

A: Screening for the HLA-B*5701 allele is important to reduce the risk of hypersensitivity reactions associated with abacavir.

Q: What are the common adverse reactions associated with abacavir sulfate and lamivudine?

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

Q: Can abacavir sulfate and lamivudine be used in patients with hepatic impairment?

A: No, abacavir sulfate and lamivudine are not recommended for patients requiring dosage adjustment or those with hepatic impairment.

Q: Are there any specific precautions for patients co-infected with hepatitis B?

A: Yes, patients co-infected with hepatitis B require close monitoring of hepatic function, and initiation of anti-hepatitis B therapy may be necessary.

Sources

1. FDA: ABACAVIR AND LAMIVUDINE - accessdata.fda.gov
2. FDA: 21652 Abacavir & Lamivudine Clinical Statistical PREA - FDA
3. Shionogi: Shionogi-ViiV Healthcare Starts Phase III Trial for “572-Trii” Fixed ...
4. FDA: Abacavir sulfate and Lamivudine tablets 60/30 mg
5. Geneesmiddeleninformatiebank: Public Assessment Report Scientific discussion Abacavir ...