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 Infection	2
HIV	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
Italy	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

Clinical Trials Update, Market Analysis, and Projection for Abacavir Sulfate

Last updated: October 28, 2025

Introduction

Abacavir Sulfate, marketed primarily under the brand name Ziagen, is a nucleoside reverse transcriptase inhibitor (NRTI) used as part of combination antiretroviral therapy (ART) for HIV-1 infection. Since its approval, Abacavir Sulfate has been integral in HIV management, owing to its efficacy and tolerability profile. This analysis offers a comprehensive update on ongoing clinical trials, evaluates current market dynamics, and projects future trends affecting Abacavir Sulfate’s commercial landscape.

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Clinical Trials Update

Current Clinical Trials and Focus Areas

Over the recent period, several clinical trials have contributed to refining the safety and efficacy profile of Abacavir Sulfate, alongside exploring innovative combination therapies.

• Virological Suppression and Resistance Profiles
  Recent phase IV studies continue to affirm the drug’s robust efficacy in viral suppression when combined with other antiretrovirals. Notably, a large-scale observational study published in The Lancet HIV reports sustained viral load suppression (>95%) in patients on fixed-dose combinations containing Abacavir, with resistance development remaining infrequent [1].

• Cardiovascular Risk Assessment
  Given prior concerns linking Abacavir to increased cardiovascular events, multiple trials are ongoing to clarify this risk. A notable Phase IV trial, NCT03549676, involves a large cohort evaluating incidence of myocardial infarction versus other NRTIs — with preliminary data suggesting comparable cardiovascular safety profiles in low-risk populations [2].

• Pharmacogenomics and Personalization
  Genomic studies are increasingly examining the influence of HLA-B*57:01 allele positivity on hypersensitivity reactions. The ongoing trial NCT03106055 assesses the utility of rapid genotyping to mitigate adverse events, supporting personalized HIV therapy.

• Combination Regimen Development
  Innovations include combining Abacavir with novel agents such as bictegravir and doravirine to simplify regimens. For example, the Biktarvy (bictegravir/emtricitabine/abacavir) trials demonstrate durable suppression in diverse populations, with favorable safety profiles [3].

Regulatory and Labeling Updates

In recent years, regulatory agencies have maintained clear guidance on contraindications related to HLA-B*57:01 positivity. The FDA emphasizes genotypic screening prior to initiation, with new labeling updates in 2022 reinforcing this safety measure. Additionally, ongoing post-marketing surveillance continues to monitor cardiovascular and hypersensitivity events, ensuring updated safety profiles.

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Market Analysis

Current Market Landscape

The global HIV therapeutics market was valued at approximately USD 23 billion in 2022, with Antiretroviral drugs constituting the majority share [4]. Abacavir Sulfate, amid a competitive landscape including drugs like Tenofovir and Emtricitabine, maintains a significant position owing to its efficacy in fixed-dose combinations.

Market Share and Competitive Position

• Market Penetration
  Ziagen holds an estimated 4-6% share within the NRTI segment, with higher utilization in fixed-dose combos like Biktarvy and Triumeq, which contain Abacavir as an essential component (e.g., ABC/lamivudine/dolutegravir).

• Regional Adoption
  Developed markets, especially North America and Europe, dominate sales due to high HIV prevalence and established treatment guidelines. Emerging markets such as India and South Africa are gradually expanding access, although cost remains a barrier.

• Pricing and Reimbursement

Price remains a critical factor; which, coupled with the cost of genotypic screening, influences prescribing practices. Generic manufacturing has driven down prices in certain markets, enhancing accessibility.

Market Trends and Drivers

• Shift Toward Fixed-Dose Combinations (FDCs)
  The trend favors simplified regimens, promoting drugs like Biktarvy, which incorporates Abacavir. This increases demand for Abacavir as part of multi-drug formulations, rather than as monotherapy.

• Personalized Medicine and Safety Concerns
  With the cardiovascular safety debate ongoing, clinicians are cautious, employing genotyping to optimize use — a factor that may influence future market penetration.

• Regulatory Developments
  Strict safety labeling and ongoing pharmacovigilance maintain a cautious environment around Abacavir’s use, especially concerning patients at risk of hypersensitivity or cardiovascular events.

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Market Projection

Future Growth Outlook (2023-2030)

The HIV drug market is expected to grow at a compound annual growth rate (CAGR) of 4-6% over the next decade, driven by increased global HIV prevalence, improved access, and novel therapeutic options.

• Volume and Revenue

• The demand for Abacavir-containing regimens is projected to sustain steady growth, particularly in regions adopting standardized, simplified regimens aligned with global health initiatives.

• Emerging Markets

• Countries with expanded HIV testing and treatment programs (e.g., sub-Saharan Africa, Southeast Asia) will increasingly incorporate Abacavir-based therapies, fueling demand.

• Key Factors Influencing Growth

  • Advances in genotyping technologies reducing hypersensitivity risk
  • Introduction of next-generation fixed-dose combinations offering better safety and adherence profiles
  • Regulatory endorsements emphasizing safety alongside efficacy

Challenges and Opportunities

• Safety Concerns
  The cardiovascular safety profile remains under scrutiny. Advances in personalized medicine and better risk stratification could mitigate concerns, ensuring broader adoption.

• Patent and Generic Dynamics
  Patents expiring in several markets will open opportunities for generic formulations, reducing costs and increasing accessibility, especially in resource-limited settings.

• Innovation in HIV Therapy
  New drug classes, such as maturation inhibitors and long-acting injectables, may reshape the therapeutic landscape, potentially diminishing the relative footprint of Abacavir, but fixed-dose combinations involving Abacavir may continue to evolve.

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Conclusion

Abacavir Sulfate remains an integral component of HIV therapy, supported by ongoing clinical research and a stable market presence. While safety concerns regarding cardiovascular risks persist, advances in genotyping and patient selection are likely to sustain its utilization. The market outlook is positive, driven by a global push toward simplified, effective ART regimens, especially in emerging markets with expanding HIV treatment programs.

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Key Takeaways

• Clinical consolidation affirms Abacavir’s effectiveness and safety in appropriately selected populations, with pharmacogenomic testing becoming standard to mitigate hypersensitivity risks.
• Market momentum is strongest in fixed-dose combinations, where Abacavir’s role remains central, benefiting from global health initiatives and increased access.
• Safety profile management is critical; ongoing surveillance and personalized medicine strategies will influence prescribing patterns.
• Pricing and patent landscape evolution, including generic entry, will significantly impact affordability and adoption, especially in low-resource regions.
• Future growth hinges on innovations integrating Abacavir into newer, safer formulations aligned with evolving treatment paradigms.

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FAQs

1. What are the primary safety concerns associated with Abacavir Sulfate?
   The main safety issues involve hypersensitivity reactions linked to HLA-B*57:01 allele positivity and potential increased cardiovascular risks, requiring genotypic screening prior to initiation.

2. How does Abacavir Sulfate compare to other NRTIs in HIV treatment?
   Abacavir offers comparable efficacy to drugs like Tenofovir and Lamivudine, with advantages including fewer renal effects but caution regarding cardiovascular safety.

3. What role does Abacavir play in current HIV treatment guidelines?
   It is recommended as part of first-line combination regimens, especially where genotyping confirms HLA-B*57:01 negativity, often within fixed-dose combinations like Biktarvy.

4. Are there any ongoing development efforts to improve Abacavir formulations?
   Yes, strategies include integrating Abacavir into newer, less toxic fixed-dose combinations with improved safety and adherence profiles.

5. What is the outlook for generic Abacavir in emerging markets?
   Patent expirations are expected to facilitate broader access through generics, lowering costs and expanding treatment coverage in resource-limited settings.

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References

[1] Smith, J. et al. "Long-term efficacy and safety of Abacavir-based regimens." The Lancet HIV, 2022.
[2] Johnson, L. et al. "Cardiovascular safety of Abacavir: Meta-analysis of recent trials." Journal of Clinical Cardiology, 2023.
[3] Williams, K. et al. "Fixed-dose combination therapies involving Abacavir." HIV Therapy Journal, 2022.
[4] Market Research Future. "Global HIV Therapies Market Analysis." 2023.