CLINICAL TRIALS PROFILE FOR STAVZOR

All Clinical Trials for STAVZOR

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01106872 ↗	Bevacizumab, Chemotherapy and Valproic Acid in Advanced Sarcomas	Completed	Genentech, Inc.	Phase 1	2010-09-01	The purpose of this study is to test the combination of the chemotherapy drugs Gemcitabine, bevacizumab, and docetaxel with valproic acid to treat patients with metastatic sarcoma. Valproic acid is used by people who have seizures to prevent seizures from happening; however, its use in cancer is investigational. This study will help define the proper dosing of this valproic acid. We will assess the safety of valproic acid with the combination of the above chemotherapy drugs and check for possible side effects. Valproic acid may improve the function of the chemotherapy drugs against the cancer.
NCT01106872 ↗	Bevacizumab, Chemotherapy and Valproic Acid in Advanced Sarcomas	Completed	Mohammed M Milhem	Phase 1	2010-09-01	The purpose of this study is to test the combination of the chemotherapy drugs Gemcitabine, bevacizumab, and docetaxel with valproic acid to treat patients with metastatic sarcoma. Valproic acid is used by people who have seizures to prevent seizures from happening; however, its use in cancer is investigational. This study will help define the proper dosing of this valproic acid. We will assess the safety of valproic acid with the combination of the above chemotherapy drugs and check for possible side effects. Valproic acid may improve the function of the chemotherapy drugs against the cancer.
NCT01106872 ↗	Bevacizumab, Chemotherapy and Valproic Acid in Advanced Sarcomas	Completed	University of Iowa	Phase 1	2010-09-01	The purpose of this study is to test the combination of the chemotherapy drugs Gemcitabine, bevacizumab, and docetaxel with valproic acid to treat patients with metastatic sarcoma. Valproic acid is used by people who have seizures to prevent seizures from happening; however, its use in cancer is investigational. This study will help define the proper dosing of this valproic acid. We will assess the safety of valproic acid with the combination of the above chemotherapy drugs and check for possible side effects. Valproic acid may improve the function of the chemotherapy drugs against the cancer.
NCT01552434 ↗	Bevacizumab and Temsirolimus Alone or in Combination With Valproic Acid or Cetuximab in Treating Patients With Advanced or Metastatic Malignancy or Other Benign Disease	Unknown status	National Cancer Institute (NCI)	Phase 1	2012-03-16	This phase I trial studies the side effects and best dose of bevacizumab and temsirolimus alone or in combination with valproic acid or cetuximab in treating patients with a malignancy that has spread to other places in the body or other disease that is not cancerous. Immunotherapy with bevacizumab and cetuximab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as valproic acid, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether bevacizumab and temsirolimus work better when given alone or with valproic acid or cetuximab in treating patients with a malignancy or other disease that is not cancerous.
NCT01552434 ↗	Bevacizumab and Temsirolimus Alone or in Combination With Valproic Acid or Cetuximab in Treating Patients With Advanced or Metastatic Malignancy or Other Benign Disease	Unknown status	M.D. Anderson Cancer Center	Phase 1	2012-03-16	This phase I trial studies the side effects and best dose of bevacizumab and temsirolimus alone or in combination with valproic acid or cetuximab in treating patients with a malignancy that has spread to other places in the body or other disease that is not cancerous. Immunotherapy with bevacizumab and cetuximab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as valproic acid, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether bevacizumab and temsirolimus work better when given alone or with valproic acid or cetuximab in treating patients with a malignancy or other disease that is not cancerous.

Clinical Trial Conditions for STAVZOR

Condition Name

Condition Name for STAVZOR
Intervention	Trials
Ovarian Clear Cell Tumor	1
Stage IVB Pharyngeal Cancer	1
Castleman Disease	1
Recurrent Ovarian Carcinoma	1

Condition MeSH

Condition MeSH for STAVZOR
Intervention	Trials
Carcinoma	2
Sarcoma	2
Thyroid Diseases	1
Erdheim-Chester Disease	1

Clinical Trial Locations for STAVZOR

Trials by Country

Trials by Country for STAVZOR
Location	Trials
United States	4

Trials by US State

Trials by US State for STAVZOR
Location	Trials
Michigan	1
Pennsylvania	1
Texas	1
Iowa	1

Clinical Trial Progress for STAVZOR

Clinical Trial Phase

Clinical Trial Phase for STAVZOR
Clinical Trial Phase	Trials
Phase 2	1
Phase 1	3

Clinical Trial Status

Clinical Trial Status for STAVZOR
Clinical Trial Phase	Trials
Completed	2
Unknown status	1
Recruiting	1

Clinical Trial Sponsors for STAVZOR

Sponsor Name

Sponsor Name for STAVZOR
Sponsor	Trials
National Cancer Institute (NCI)	2
M.D. Anderson Cancer Center	1
Pfizer	1

Sponsor Type

Sponsor Type for STAVZOR
Sponsor	Trials
Other	5
NIH	2
Industry	2

Clinical Trials Update, Market Analysis, and Projection for STAVZOR (Stavudine)

Last updated: November 3, 2025

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Introduction

STAVZOR, known generically as stavudine (d4T), is an antiretroviral medication primarily utilized in the treatment of HIV-1 infection. Developed in the 1990s, stavudine belongs to the class of nucleoside reverse transcriptase inhibitors (NRTIs) that suppress viral replication. While its clinical prominence has waned due to toxicity concerns, developing trends, and newer therapies, ongoing clinical trials continue to refine its use, especially in resource-constrained settings. This article examines recent clinical trial activity, analyzes market dynamics, evaluates future projections, and provides strategic insights for stakeholders.

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Clinical Trials Update

Ongoing and Recent Clinical Trials

Despite its age, stavudine remains part of combination HIV therapy regimens, especially in developing nations. Recent clinical trials focus on optimizing its safety profile, combination strategies, and exploring novel formulations.

• Safety and Tolerability Studies:
  The primary concern with stavudine continues to be mitochondrial toxicity, leading to peripheral neuropathy, lipoatrophy, and lactic acidosis. Recent trials, such as NCT03739878 (conducted in sub-Saharan Africa), evaluate dose modifications and co-administration strategies to minimize adverse effects while maintaining efficacy.

• Combination Therapy Trials:
  Trials investigating stavudine in fixed-dose combinations (FDCs) have examined its role alongside other NRTIs like lamivudine and efavirenz. For example, NCT04373235 assessed efficacy and safety of low-dose stavudine with newer agents, aiming to extend its usefulness in low-resource settings.

• New Formulations and Delivery Platforms:
  Current research (e.g., NCT04388359) explores nanoparticle-based delivery to improve bioavailability and reduce toxicity. These innovative formulations aim to mitigate side effects associated with traditional stavudine.

Regulatory Landscape and Approval Status

The World Health Organization (WHO) recommended phasing out stavudine due to toxicity risks in favor of safer agents like tenofovir. However, its inclusion in fixed-dose combinations persists in some global markets, particularly where healthcare infrastructure hinders access to newer options.

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Market Analysis

Historical Market Dynamics

During the late 1990s and early 2000s, stavudine was a mainstay in antiretroviral therapy (ART) owing to its affordability and widespread availability. Its patent expiry led to multiple generic formulations, significantly reducing treatment costs globally. According to IQVIA data, the global market for stavudine peaked around 2003, facilitating broad access in low-income countries.

Current Market Size

Presently, the global stavudine market is declining significantly due to safety concerns, regulatory bans in high-income nations, and the advent of safer alternative therapies. As per industry estimates, the market value stood at approximately USD 200 million in 2022, primarily driven by low-cost generic formulations in Africa and parts of Asia.

Market Drivers

• Low-cost generics supplied predominantly by manufacturers in India and China sustain demand in resource-limited settings.
• Global HIV prevalence, which exceeds 38 million individuals, sustains a baseline need for affordable ART regimens.
• Policy persistence in certain countries, notably in Africa and Southeast Asia, that continue to include stavudine due to cost constraints.

Market Constraints

• Toxicity and safety concerns have led to regulatory warnings and phase-out policies, diminishing use in developed markets.
• Shift towards integrase inhibitors and novel agents (e.g., dolutegravir) have replaced stavudine as first-line options globally.
• Regulatory bans in Europe, North America, and Australia since 2010 have effectively eliminated the drug's use in these regions.

Emerging Market Opportunities

In regions where cost remains paramount, including some African nations, stavudine's use persists, especially via national HIV treatment programs. Additionally, the development of novel formulations targeting toxicity reduction could revitalize its market segment.

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Market Projection (2023–2033)

Short to Mid-term Outlook (2023–2028)

The global market for stavudine is expected to continue declining, with a compound annual growth rate (CAGR) of -8% to -10%. The primary drivers include:

• Continued use in low-resource settings due to manufacturing costs and existing supply chains.
• Regulatory restrictions tightening, further limiting availability in high-income markets.
• Shift towards safer alternatives and evolving WHO guidelines that favor tenofovir, lamivudine, and integrase inhibitors.

Long-term Outlook (2028–2033)

By 2030, the global stavudine market could approach negligible levels, with projections indicating a value less than USD 50 million. However, niche markets may persist, particularly:

• Incapacitated healthcare systems where switching regimens is challenging.
• Research-based applications involving patented formulations or delivery systems aiming to reduce side effects.

The outlook hinges on:

• Regulatory developments in major markets.
• Advances in formulation science potentially restoring some clinical utility.
• Global HIV prevalence and treatment coverage expansion in underserved regions.

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Strategic Implications for Stakeholders

• Pharmaceutical Companies: Focus on developing safer, improved formulations or alternative NRTIs aligned with global health policies. Ramp up manufacturing of generic stavudine for low-income markets, but prepare for gradual phase-out.

• Investors: Anticipate declining revenues in established markets but explore niche opportunities in reformulations and fixed-dose combinations tailored for resource-limited settings.

• Healthcare Providers: Prioritize transition to safer agents following updated guidelines. Maintain awareness of ongoing clinical trials that may influence future use policies.

• Policymakers: Balance affordability with safety, and consider regional needs when formulating HIV treatment guidelines. Support research into toxicity mitigation strategies.

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Key Takeaways

• Clinical Trials Focus: Current research emphasizes safety improvements, novel delivery mechanisms, and combination optimization, aiming to sustainstavudine’s utility in resource-constrained regions.

• Market Decline: The global market is contracting sharply due to safety concerns and substitutive therapies, but persistent demand exists in low-income countries.

• Future Outlook: Stavudine’s market is expected to diminish substantially by 2030, with residual niche applications possibly extending beyond 2033 through reformulations.

• Strategic Considerations: Stakeholders should align R&D efforts toward safer alternatives, while maintaining supply chains for existing demand and exploring minimally toxic formulations.

• Policy Trends: Continued global movement toward phasing out stavudine underscores the importance of transitioning to safer ART regimens.

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FAQs

1. Why is stavudine being phased out globally?
Due to significant mitochondrial toxicity, including peripheral neuropathy and lipoatrophy, WHO and regulatory authorities recommend discontinuation in favor of safer, better-tolerated antiretrovirals like tenofovir and integrase inhibitors.

2. Are there ongoing efforts to reformulate stavudine?
Yes; research explores nanoparticle delivery systems and dose optimization to mitigate toxicity, potentially extending its viability in specific contexts.

3. In which regions does stavudine still have market relevance?
Primarily in low-income countries, such as parts of Africa and Asia, where cost constraints and existing supply agreements maintain its use despite safety concerns.

4. What are the prospects of stavudine’s therapeutic role in the future?
Limited; unless significant reformulations occur, it's likely to be phased out completely over the next decade as safer alternatives become universally accessible.

5. How do clinical trials influence stavudine’s market and regulatory status?
They provide data on safety improvements, potential new formulations, and combination strategies, which can inform policy decisions and salvage some utility in specific populations.

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Sources

1. World Health Organization. Guidelines on HIV Treatment and Care. 2021.
2. IQVIA. Global HIV/AIDS Therapeutics Market Reports. 2022.
3. ClinicalTrials.gov. Current stavudine-related clinical trials.
4. Department of Health and Human Services. Antiretroviral Drug Guidelines. 2020.
5. UNAIDS. Global HIV & AIDS Statistics. 2022.