CLINICAL TRIALS PROFILE FOR ABACAVIR SULFATE AND LAMIVUDINE

All Clinical Trials for Abacavir Sulfate And 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 And Lamivudine

Condition Name

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

Condition MeSH

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

Clinical Trial Locations for Abacavir Sulfate And Lamivudine

Trials by Country

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

Trials by US State

Trials by US State for Abacavir Sulfate And Lamivudine
Location	Trials
New York	4
North Carolina	3
Illinois	3
Georgia	2
Florida	2

Clinical Trial Progress for Abacavir Sulfate And Lamivudine

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for Abacavir Sulfate And Lamivudine

Sponsor Name

Sponsor Name for Abacavir Sulfate And Lamivudine
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	5
GlaxoSmithKline	2
ViiV Healthcare	1

Sponsor Type

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

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

Introduction

Abacavir sulfate and lamivudine, a combination of two nucleoside analogue HIV-1 reverse transcriptase inhibitors, is a crucial component 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 Indications and Usage

Abacavir sulfate and lamivudine tablets are indicated for the treatment of HIV-1 infection in combination with other antiretroviral agents. This combination is effective in suppressing the HIV-1 virus and is used in both adult and pediatric patients[1][2].

Dosage and Administration

The dosage of abacavir sulfate and lamivudine is typically one tablet daily for adults and pediatric patients weighing at least 25 kg. For pediatric patients weighing less than 25 kg, the dosage is adjusted based on body weight. It is crucial to screen for the HLA-B*5701 allele before initiating therapy to avoid hypersensitivity reactions[1][2].

Clinical Trials Update

ARROW Trial

The ARROW trial assessed the safety and efficacy of once-daily versus twice-daily dosing of abacavir and lamivudine in pediatric patients. The trial found that once-daily dosing was as effective and safe as twice-daily dosing, with no additional safety issues identified in the once-daily cohort[1][5].

REPRIEVE Trial

A significant recent update comes from the REPRIEVE trial, which investigated the cardiovascular risk associated with various antiretroviral drugs, including abacavir. The trial found that current or previous use of abacavir was associated with a 42% to 50% elevated risk of major adverse cardiovascular events (MACE) compared to those with no abacavir exposure. This finding aligns with previous studies indicating an increased cardiovascular disease risk associated with abacavir[3].

Adverse Reactions and Safety Concerns

Hypersensitivity Reactions

Abacavir is known to cause severe hypersensitivity reactions, which can be fatal. These reactions are characterized by symptoms such as fever, rash, gastrointestinal issues, constitutional symptoms, and respiratory problems. Discontinuation of the drug is necessary upon the first appearance of these symptoms, and reintroduction of abacavir or any abacavir-containing product should be avoided[1][2].

Lactic Acidosis and Hepatomegaly

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues, including abacavir and lamivudine. Close monitoring of hepatic function is essential, especially in patients co-infected with hepatitis B virus (HBV)[1][2].

Exacerbations of Hepatitis B

Severe acute exacerbations of hepatitis B can occur in patients co-infected with HBV and HIV-1 who discontinue lamivudine. Hepatic function should be closely monitored, and anti-hepatitis B therapy may be warranted if necessary[1][2].

Market Analysis

Market Demand

The demand for antiretroviral therapies, including abacavir sulfate and lamivudine, remains high due to the ongoing need for effective HIV-1 treatment. The global HIV/AIDS market is driven by the increasing prevalence of HIV, advancements in antiretroviral therapies, and government initiatives to improve access to treatment.

Competitive Landscape

The market for HIV-1 treatments is highly competitive, with several antiretroviral drugs available. However, the combination of abacavir sulfate and lamivudine remains a significant player due to its efficacy and convenience as a once-daily regimen. Other combinations, such as those including dolutegravir, also compete in this space[4].

Projections

Future Trends

Given the findings from the REPRIEVE trial, there may be a shift towards alternative antiretroviral regimens that do not include abacavir, especially for patients at higher risk of cardiovascular events. However, the convenience and established efficacy of abacavir sulfate and lamivudine will likely maintain its place in the treatment arsenal.

Regulatory Considerations

Regulatory bodies may revisit the safety profile of abacavir sulfate and lamivudine in light of the new cardiovascular risk data. This could lead to updated labeling or additional monitoring requirements for patients on this regimen.

Key Takeaways

• Clinical Indications: Abacavir sulfate and lamivudine are indicated for HIV-1 infection treatment in combination with other antiretrovirals.
• Dosage: Once-daily dosing for adults and pediatric patients weighing at least 25 kg, with adjustments for younger patients.
• Clinical Trials: The ARROW trial supported once-daily dosing, while the REPRIEVE trial highlighted an increased cardiovascular risk associated with abacavir.
• Safety Concerns: Hypersensitivity reactions, lactic acidosis, hepatomegaly, and exacerbations of hepatitis B are significant safety issues.
• Market Analysis: High demand driven by HIV prevalence and government initiatives, with a competitive market landscape.
• Projections: Potential shift towards alternative regimens due to cardiovascular risks, but the drug combination is likely to remain relevant.

FAQs

What is the recommended dosage for abacavir sulfate and lamivudine?

The recommended dosage is one tablet daily for adults and pediatric patients weighing at least 25 kg. For younger pediatric patients, the dosage is adjusted based on body weight[1][2].

What are the significant safety concerns associated with abacavir sulfate and lamivudine?

Hypersensitivity reactions, lactic acidosis, severe hepatomegaly, and exacerbations of hepatitis B are the major safety concerns[1][2].

How does the REPRIEVE trial impact the use of abacavir sulfate and lamivudine?

The REPRIEVE trial found an elevated risk of major adverse cardiovascular events associated with abacavir, which may lead to a reevaluation of its use, especially in patients at higher cardiovascular risk[3].

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

No, abacavir sulfate and lamivudine are not recommended for patients requiring dosage adjustment or those with hepatic impairment[1][2].

What is the impact of the ARROW trial on the dosing regimen of abacavir sulfate and lamivudine in pediatric patients?

The ARROW trial supported the safety and efficacy of once-daily dosing of abacavir sulfate and lamivudine in pediatric patients, which simplifies the treatment regimen[1][5].

Sources

1. FDA: ABACAVIR AND LAMIVUDINE - accessdata.fda.gov
2. FDA: Abacavir sulfate and Lamivudine tablets 60/30 mg - accessdata.fda.gov
3. NIH: Exploratory analysis associates HIV drug abacavir with elevated risk for cardiovascular events in the REPRIEVE trial - nih.gov
4. Patsnap Synapse: Abacavir sulfate/Dolutegravir sodium/Lamivudine - synapse.patsnap.com
5. FDA: 21652 Abacavir & Lamivudine Clinical Statistical PREA - fda.gov