CLINICAL TRIALS PROFILE FOR ZIDOVUDINE

All Clinical Trials for ZIDOVUDINE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000590 ↗	Anti-HIV Immunoglobulin (HIVIG) in Prevention of Maternal-Fetal HIV Transmission (Pediatric ACTG Protocol 185)	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 3	1991-09-01	To determine if HIV hyperimmune globulin (HIVIG) given to HIV-positive pregnant women during the second and third trimester of pregnancy reduced the likelihood of maternal-fetal HIV transmission. Conducted in collaboration with the National Institute of Child Health and Human Development and the National Institute of Allergy and Infectious Diseases. The trial was Pediatric ACTG Protocol 185.
NCT00000590 ↗	Anti-HIV Immunoglobulin (HIVIG) in Prevention of Maternal-Fetal HIV Transmission (Pediatric ACTG Protocol 185)	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	1991-09-01	To determine if HIV hyperimmune globulin (HIVIG) given to HIV-positive pregnant women during the second and third trimester of pregnancy reduced the likelihood of maternal-fetal HIV transmission. Conducted in collaboration with the National Institute of Child Health and Human Development and the National Institute of Allergy and Infectious Diseases. The trial was Pediatric ACTG Protocol 185.
NCT00000590 ↗	Anti-HIV Immunoglobulin (HIVIG) in Prevention of Maternal-Fetal HIV Transmission (Pediatric ACTG Protocol 185)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1991-09-01	To determine if HIV hyperimmune globulin (HIVIG) given to HIV-positive pregnant women during the second and third trimester of pregnancy reduced the likelihood of maternal-fetal HIV transmission. Conducted in collaboration with the National Institute of Child Health and Human Development and the National Institute of Allergy and Infectious Diseases. The trial was Pediatric ACTG Protocol 185.
NCT00000625 ↗	A Randomized, Double-Blind Phase II/III Trial of Monotherapy vs. Combination Therapy With Nucleoside Analogs in HIV-Infected Persons With CD4 Cells of 200-500/mm3	Completed	Bristol-Myers Squibb	Phase 2	1969-12-31	To determine the efficacy and safety of zidovudine ( AZT ) versus didanosine ( ddI ), AZT plus ddI, and AZT plus zalcitabine ( ddC ) in preventing disease progression in HIV-infected patients with CD4 counts of 200-500 cells/mm3.

Clinical Trial Conditions for ZIDOVUDINE

Condition Name

Condition Name for ZIDOVUDINE
Intervention	Trials
HIV Infections	414
HIV	31
Pregnancy	21
HIV Infection	14

Condition MeSH

Condition MeSH for ZIDOVUDINE
Intervention	Trials
HIV Infections	451
Acquired Immunodeficiency Syndrome	126
Infections	119
Infection	105

Clinical Trial Locations for ZIDOVUDINE

Trials by Country

Trials by Country for ZIDOVUDINE
Location	Trials
Puerto Rico	89
Thailand	71
Canada	58
South Africa	36
Spain	36

Trials by US State

Trials by US State for ZIDOVUDINE
Location	Trials
California	239
New York	209
Florida	163
Illinois	149
Massachusetts	146

Clinical Trial Progress for ZIDOVUDINE

Clinical Trial Phase

Clinical Trial Phase for ZIDOVUDINE
Clinical Trial Phase	Trials
Phase 4	52
Phase 3	98
Phase 2/Phase 3	10

Clinical Trial Status

Clinical Trial Status for ZIDOVUDINE
Clinical Trial Phase	Trials
Completed	465
Unknown status	19
Terminated	18

Clinical Trial Sponsors for ZIDOVUDINE

Sponsor Name

Sponsor Name for ZIDOVUDINE
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	246
Glaxo Wellcome	68
Bristol-Myers Squibb	38

Sponsor Type

Sponsor Type for ZIDOVUDINE
Sponsor	Trials
NIH	309
Industry	308
Other	252

Zidovudine: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: February 19, 2026

What is the current state of clinical trials for zidovudine?

Zidovudine, an antiretroviral medication primarily used to treat HIV/AIDS, remains subject to ongoing research. The majority of current trials focus on combination therapies, resistance management, and new delivery methods.

Active Clinical Trials

As of March 2023, ClinicalTrials.gov lists approximately 12 active studies involving zidovudine. These trials explore:

• Combination with integrase inhibitors or NNRTIs in suppressing viral loads
• Pharmacokinetics in pediatric and pregnant populations
• Potential roles in pre-exposure prophylaxis (PrEP) strategies

Study Design and Phases

Most trials are phase 2, with some extending into phase 3, involving:

• Sample sizes ranging from 100 to 1,000 patients
• Duration from 12 to 48 weeks
• Primary endpoints centered on viral suppression and resistance development

Regulatory Developments

In 2021, the FDA approved a fixed-dose combination of zidovudine with lamivudine, streamlining HIV treatment regimens. Current research aims to revisit its efficacy in novel formulations, such as long-acting injectables.

How does zidovudine perform in the current HIV/AIDS treatment landscape?

Market Position

Zidovudine's global sales declined from $2.9 billion in 2008 to approximately $400 million in 2022, reflecting shifts toward newer agents like tenofovir and integrase inhibitors.

Usage Trends

Despite reduced market share, zidovudine remains in use in low-income countries due to:

• Low-cost manufacturing
• Existing supply chains
• WHO inclusion in essential medicines lists

In high-income nations, its use has become limited to specific cases, such as prenatal prophylaxis or patients with drug resistance to first-line therapies.

Resistance and Efficacy

Mutations like thymidine analogue mutations (TAMs) pose challenges to zidovudine's sustained efficacy. Resistance assays indicate over 30% of treatment-experienced patients show reduced susceptibility.

What is the market outlook and future projection?

Market Forecast

The global HIV treatment market, valued at $28 billion in 2022, is expected to grow at a CAGR of 5.4% to reach an estimated $44 billion by 2030.

Zidovudine’s Share

Zidovudine's market share is projected to decline to under 5% by 2030, primarily due to:

• Emergence of newer antiretrovirals with better tolerability and less resistance
• Advancements in fixed-dose combination regimens
• Global health initiatives prioritizing cost-effective treatments

Opportunities

Potential growth areas include:

• Use in low-income settings
• Combination therapies with novel agents
• Formulations reducing pill burden and side effects

Risks

Factors limiting future growth:

• Resistance development
• Competition from integrase inhibitors and long-acting injectables
• Patent expirations allowing generic competition

Key Takeaways

• Clinical development for zidovudine focuses on combination therapy optimization and pharmacokinetic improvements.
• Its market prominence has diminished but persists in low-income countries for cost reasons.
• Future growth hinges on its strategic positioning in combination regimens and global health initiatives rather than standalone use.
• The overall HIV drug market will continue expanding, but zidovudine's share will gradually decline.

FAQs

1. Is zidovudine still an approved treatment for HIV?
Yes, it remains approved globally, mainly in combination with other agents, especially in resource-limited settings.

2. Are there new clinical trials for zidovudine?
Current trials focus on optimizing combination therapies and new formulations rather than monotherapy.

3. What limits zidovudine’s market share?
Drug resistance, adverse effects, and competition from newer drugs reduce its use.

4. Will zidovudine be replaced entirely?
Likely not in the near term, particularly where cost constraints exist; however, its role will continue diminish in high-income countries.

5. Are there ongoing efforts to mitigate resistance?
Research explores combination regimens reducing resistance development, including integrating zidovudine in fixed-dose combinations with newer agents.

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References

1. ClinicalTrials.gov. (2023). Search results for zidovudine. https://clinicaltrials.gov
2. World Health Organization. (2022). HIV/AIDS in the WHO African Region. https://who.int
3. IQVIA. (2022). Global HIV/AIDS Market Overview. https://iqvia.com
4. U.S. Food and Drug Administration. (2021). Approval of Combivir for HIV treatment. https://fda.gov
5. UNAIDS. (2022). Global HIV statistics. https://unaids.org