CLINICAL TRIALS PROFILE FOR ABACAVIR SULFATE

All Clinical Trials for Abacavir Sulfate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000864 ↗	A Study to Test the Safety, Tolerance, and Metabolism of Abacavir (1592U89, ABC) With Standard Zidovudine (ZDV) Therapy in Newborn Infants Born to HIV-1 Infected Women	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 determine the safety, tolerance, and metabolism of single-dose and multiple-dose abacavir (ABC) in HIV-exposed infants receiving standard postnatal treatment with zidovudine (ZDV). This study also evaluates the correct dosages of ABC to be used in future studies. Early aggressive therapy may be the best chance to slow disease progression in infants who may have been infected with HIV by their mothers. Early HIV suppression may significantly reduce viral levels and allow for restoration of the immune system, providing improved control over HIV infection. Therefore, it is important that the safety and tolerance of ABC in combination with ZDV be examined as potential early therapy in newborn and young infants.
NCT00000864 ↗	A Study to Test the Safety, Tolerance, and Metabolism of Abacavir (1592U89, ABC) With Standard Zidovudine (ZDV) Therapy in Newborn Infants Born to HIV-1 Infected Women	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	The purpose of this study is to determine the safety, tolerance, and metabolism of single-dose and multiple-dose abacavir (ABC) in HIV-exposed infants receiving standard postnatal treatment with zidovudine (ZDV). This study also evaluates the correct dosages of ABC to be used in future studies. Early aggressive therapy may be the best chance to slow disease progression in infants who may have been infected with HIV by their mothers. Early HIV suppression may significantly reduce viral levels and allow for restoration of the immune system, providing improved control over HIV infection. Therefore, it is important that the safety and tolerance of ABC in combination with ZDV be examined as potential early therapy in newborn and young infants.
NCT00000865 ↗	The Safety and Effects of 1592U89 Used Alone or in Combination With Other Anti-HIV Drugs in HIV-Infected Infants and Children	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	To assess the steady state pharmacokinetic features, tolerance, and safety of orally administered 1592U89, given alone or in combination with other antiretroviral medications, in HIV infected infants and children. To establish doses of 1592U89 appropriate for future pediatric Phase II/III clinical trials. On the basis of the preclinical and clinical studies, 1592U89 appears to be a promising agent for treatment of HIV infection in children, either as an alternative to currently employed agents, or in combination therapy regimens. A liquid formulation of the drug is available; thus concurrent development of 1592U89 for children and adults is possible.
NCT00000872 ↗	Treatment With Combinations of Several Antiviral Drugs in Infants and Young Children With HIV Infection	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 2	1969-12-31	This trial tests the safety and effectiveness of the early use of combinations of anti-HIV drugs in HIV-infected infants and young children in an effort to block virus growth and preserve normal immune functions. Various anti-HIV drug combinations need to be tested in order to find the best way to treat infants and children who have been infected with HIV during birth.
NCT00000872 ↗	Treatment With Combinations of Several Antiviral Drugs in Infants and Young Children With HIV Infection	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	This trial tests the safety and effectiveness of the early use of combinations of anti-HIV drugs in HIV-infected infants and young children in an effort to block virus growth and preserve normal immune functions. Various anti-HIV drug combinations need to be tested in order to find the best way to treat infants and children who have been infected with HIV during birth.
NCT00000885 ↗	Treatment Success and Failure in HIV-Infected Subjects Receiving Indinavir in Combination With Nucleoside Analogs: A Rollover Study for ACTG 320	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	Group A: To compare the time to confirmed virologic failure (2 consecutive plasma HIV-RNA concentrations of 500 copies/ml or more) between the treatment arms: abacavir (ABC) or placebo in combination with zidovudine (ZDV), lamivudine (3TC), and indinavir (IDV). To evaluate the safety and tolerability of these treatment arms. [AS PER AMENDMENT 06/16/99: To compare the time to confirmed treatment failure, permanent discontinuation of treatment, or death between the treatment arms.] [AS PER AMENDMENT 12/27/01: Groups B, C, and D completed follow-up on March 4, 1999. Therefore, only information pertinent to Group A is applicable.] Group B: To compare the proportion of patients who achieve plasma HIV-1 RNA concentrations below 500 copies/ml, as assessed by the standard Roche Amplicor assay at Week 16, or to compare the absolute changes in plasma HIV-1 RNA concentrations at Week 16 across the treatment arms: ABC or approved nucleoside analogs and nelfinavir (NFV) or placebo in combination with efavirenz (EFV) and adefovir dipivoxil. To compare the safety and tolerability of these treatment arms. Group C: To monitor plasma HIV-1 RNA trajectory over time and determine the time to a confirmed plasma HIV-1 RNA concentration above 2,000 copies/ml on 2 consecutive determinations for patients treated with ZDV or stavudine (d4T) plus 3TC and IDV. Group D: To evaluate plasma HIV-1 RNA responses at Weeks 16 and 48. To evaluate the safety and tolerability of the treatment arms: ABC, EFV, adefovir dipivoxil, and NFV. This study explores new treatment options for ACTG 320 enrollees (and, if needed, a limited number of non-ACTG 320 volunteers) who have been receiving ZDV (or d4T) plus 3TC and IDV and are currently exhibiting a range of virologic responses. By dividing the study into the corresponding, nonsequential cohorts (Groups A, B, C, D), different approaches to evaluating virologic success, i.e., undetectable plasma HIV-1 RNA levels, and virologic failure, i.e., plasma HIV-1 RNA levels of 500 copies/ml or more [AS PER AMENDMENT 12/27/01: 200 copies/ml or more], are explored while maintaining long-term follow-up of ACTG 320 patients. [AS PER AMENDMENT 12/27/01: Groups B, C, and D completed follow-up on March 4, 1999. Therefore, only information pertinent to Group A is applicable. This study will examine the question of whether intensification of therapy can prolong the virologic benefit in individuals whose plasma HIV-1 RNA concentrations have been below the limits of assay detection on ZDV (or d4T) plus 3TC plus IDV.]
NCT00000912 ↗	A Study on Amprenavir in Combination With Other Anti-HIV Drugs in HIV-Positive Patients	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	The purpose of this study is to compare 4 different combinations of anti-HIV drugs and to determine the number of people whose HIV blood levels decrease to 200 copies/ml or less while on the treatment. This study evaluates the safety of these drug combinations, which include an experimental protease inhibitor (PI), amprenavir. Despite the success that many patients have had with PI treatment regimens, there is still a possibility that patients receiving PIs may continue to have high HIV blood levels. Because of this possibility, alternative drug combinations containing PIs are being studied. It appears that amprenavir, when taken with 3 or 4 other anti-HIV drugs, may be effective in patients with prior PI treatment experience.

Clinical Trial Conditions for Abacavir Sulfate

Condition Name

Condition Name for Abacavir Sulfate
Intervention	Trials
HIV Infections	59
Lipodystrophy	3
HIV	2
HIV Infection	2

Condition MeSH

Condition MeSH for Abacavir Sulfate
Intervention	Trials
HIV Infections	63
Infections	21
Infection	21
Acquired Immunodeficiency Syndrome	15

Clinical Trial Locations for Abacavir Sulfate

Trials by Country

Trials by Country for Abacavir Sulfate
Location	Trials
United States	499
Puerto Rico	11
Canada	10
Mexico	4
Australia	2

Trials by US State

Trials by US State for Abacavir Sulfate
Location	Trials
New York	42
California	38
North Carolina	33
Illinois	30
Florida	27

Clinical Trial Progress for Abacavir Sulfate

Clinical Trial Phase

Clinical Trial Phase for Abacavir Sulfate
Clinical Trial Phase	Trials
Phase 4	8
Phase 3	15
Phase 2	20

Clinical Trial Status

Clinical Trial Status for Abacavir Sulfate
Clinical Trial Phase	Trials
Completed	58
Unknown status	4
Withdrawn	2

Clinical Trial Sponsors for Abacavir Sulfate

Sponsor Name

Sponsor Name for Abacavir Sulfate
Sponsor	Trials
Glaxo Wellcome	30
National Institute of Allergy and Infectious Diseases (NIAID)	27
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	5

Sponsor Type

Sponsor Type for Abacavir Sulfate
Sponsor	Trials
Industry	43
NIH	33
Other	6

Abacavir Sulfate: Clinical Trials, Market Analysis, and Projections

Introduction to Abacavir Sulfate

Abacavir sulfate is a small molecule drug used in the treatment of HIV-1 infection. It belongs to the class of reverse transcriptase inhibitors (RTIs), which work by inhibiting the reverse transcriptase enzyme, a crucial component in the replication cycle of the HIV virus[1].

Clinical Trials and Safety Concerns

Recent Findings on Cardiovascular Risk

A significant update from clinical trials involves the NIH-funded REPRIEVE study, which investigated the cardiovascular risks associated with various antiretroviral therapies, including abacavir. The study, involving 7,769 subjects from 12 countries, found that abacavir is linked to a higher risk of major adverse cardiovascular events (MACE), such as heart attacks and strokes. However, the study also noted that a daily cholesterol-fighting statin regimen can reduce this risk by over one-third[3].

Ongoing and Completed Trials

Abacavir sulfate has been part of numerous clinical trials, often in combination with other antiretroviral drugs. For instance, the drug has been studied in combination with dolutegravir sodium and lamivudine, with trials focusing on resistance analyses and efficacy in HIV-1 treatment[4].

Market Analysis

Current Market Size and Forecast

The global market for abacavir sulfate was valued at US$ 688.2 million in 2023. It is anticipated to grow significantly, reaching US$ 1194.5 million by 2030, with a compound annual growth rate (CAGR) of 8.2% during the forecast period of 2024-2030[2][5].

Regional Market Segmentation

The market is segmented by region, with North America, Europe, and the Asia-Pacific being key areas. Each region is expected to see growth, though specific CAGR rates for these regions are not detailed in the available data. The Asia-Pacific market, in particular, is expected to contribute significantly to the overall growth due to increasing healthcare expenditures and a growing patient population[2].

Key Manufacturers

The global abacavir sulfate market is dominated by several major manufacturers, including GlaxoSmithKline (GSK), Aurobindo, Novnauki, Smilax, Hycultec, and Atripla. In 2023, the top three vendors accounted for a significant portion of the revenue, though the exact percentage is not specified[2].

Market Segmentation and Competitive Landscape

Segmentation by Type and Sale Channel

The market is segmented by type of product and sale channel. This includes different formulations of abacavir sulfate, such as tablets and combinations with other antiretroviral drugs. The sale channels include retail pharmacies, hospitals, and online platforms. Understanding these segments helps manufacturers and new entrants develop targeted business strategies[2].

Competitive Landscape

The competitive landscape of the abacavir sulfate market is characterized by the presence of both established and emerging players. The report provides profiles of key competitors, their market ranks, and technological trends. This information is crucial for companies looking to assess their position in the market and make informed business decisions[2].

Technological Trends and New Product Developments

Combination Therapies

One of the significant trends in the abacavir sulfate market is the development of combination therapies. For example, the combination of abacavir sulfate with dolutegravir sodium and lamivudine has been approved and is widely used. These combination therapies offer improved efficacy and convenience for patients, driving market growth[4].

Resistance Analyses

Ongoing research focuses on resistance analyses to ensure the long-term efficacy of abacavir sulfate and its combinations. This includes studies from trials like the Remdesivir Phase 2/3 Caravan Study, which help in understanding and mitigating drug resistance[4].

Regulatory and Approval Status

Approval History

Abacavir sulfate was first approved in the US on December 17, 1998, and has since been approved in various other countries. It has received accelerated approval in the US and is designated as an orphan drug in Japan[1].

Regulatory Considerations

The drug has undergone priority review in certain regions, such as China. Regulatory approvals and designations play a crucial role in the market availability and adoption of abacavir sulfate[1].

Conclusion

Abacavir sulfate remains a vital component in the treatment of HIV-1 infection, despite recent findings on its cardiovascular risks. The market for this drug is expected to grow significantly, driven by increasing demand and advancements in combination therapies.

Key Takeaways

• Market Growth: The global abacavir sulfate market is projected to reach US$ 1194.5 million by 2030, with a CAGR of 8.2% from 2024 to 2030.
• Clinical Concerns: Recent trials have linked abacavir to higher cardiovascular risks, but statin regimens can mitigate this risk.
• Combination Therapies: The development of combination therapies, such as with dolutegravir sodium and lamivudine, is a significant trend.
• Regulatory Status: Abacavir sulfate has been approved in several countries and has undergone priority reviews in some regions.
• Market Segmentation: The market is segmented by region, type, and sale channel, with key manufacturers dominating the landscape.

FAQs

Q: What is the current market size of abacavir sulfate, and what is its projected growth?

A: The global market for abacavir sulfate was valued at US$ 688.2 million in 2023 and is expected to reach US$ 1194.5 million by 2030, with a CAGR of 8.2% during the forecast period[2][5].

Q: Which companies are the major manufacturers of abacavir sulfate?

A: The major global manufacturers include GSK, Aurobindo, Novnauki, Smilax, Hycultec, and Atripla[2].

Q: What are the recent clinical findings regarding the use of abacavir sulfate?

A: Recent clinical trials, such as the REPRIEVE study, have linked abacavir sulfate to a higher risk of major adverse cardiovascular events, though statin regimens can reduce this risk[3].

Q: What are the key trends in the abacavir sulfate market?

A: Key trends include the development of combination therapies and ongoing research into resistance analyses to ensure long-term efficacy[4].

Q: What is the regulatory status of abacavir sulfate?

A: Abacavir sulfate was first approved in the US in 1998 and has since received approvals in other countries, including priority reviews and orphan drug designations in certain regions[1].

Sources

1. Synapse Patsnap: Abacavir Sulfate - Drug Targets, Indications, Patents.
2. QYResearch: Global Abacavir Market Research Report 2024.
3. Clinical Trials Arena: NIH trial finds HIV drug abacavir linked to higher cardiovascular risk.
4. Synapse Patsnap: Abacavir sulfate/Dolutegravir sodium/Lamivudine.
5. Valuates Reports: Abacavir - Market, Report Size, Worth, Revenue, Growth, Industry.