CLINICAL TRIALS PROFILE FOR COMBIVIR

All Clinical Trials for COMBIVIR

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000887 ↗	A Study to Evaluate the Safety and Tolerance of Nelfinavir (NFV) Given With Zidovudine (ZDV) and Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants	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 see if giving nelfinavir (NFV) plus zidovudine (ZDV) plus lamivudine (3TC) to HIV-positive pregnant women and their babies is safe. This study will also look at how long these drugs stay in the blood. ZDV has been given to mothers in the past to reduce the chances of passing HIV on to their babies. However, better treatments are needed to further reduce these chances and to better suit the treatment needs of mothers and their children. Taking a combination of anti-HIV drugs during pregnancy may be an answer.
NCT00000887 ↗	A Study to Evaluate the Safety and Tolerance of Nelfinavir (NFV) Given With Zidovudine (ZDV) and Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	The purpose of this study is to see if giving nelfinavir (NFV) plus zidovudine (ZDV) plus lamivudine (3TC) to HIV-positive pregnant women and their babies is safe. This study will also look at how long these drugs stay in the blood. ZDV has been given to mothers in the past to reduce the chances of passing HIV on to their babies. However, better treatments are needed to further reduce these chances and to better suit the treatment needs of mothers and their children. Taking a combination of anti-HIV drugs during pregnancy may be an answer.
NCT00000888 ↗	Safety and Effectiveness of Ritonavir Plus Lamivudine Plus Zidovudine in HIV-Infected Pregnant Women and Their Babies	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 see if it is safe and effective to give ritonavir (RTV) plus lamivudine (3TC) plus zidovudine (ZDV) to HIV-infected pregnant women during pregnancy and to their babies after birth. Pregnant women who are HIV-positive are at risk of giving HIV to their babies during pregnancy or delivery. It is important to learn how to prevent HIV-positive pregnant women from giving HIV to their babies. RTV and ZDV have been shown to be safe and effective against HIV in adults. The combination of 3 anti-HIV drugs (RTV, 3TC, and ZDV) may help prevent HIV infection from mother to infant but studies are needed to determine whether they are safe and effective during pregnancy.
NCT00000888 ↗	Safety and Effectiveness of Ritonavir Plus Lamivudine Plus Zidovudine in HIV-Infected Pregnant Women and Their Babies	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	The purpose of this study is to see if it is safe and effective to give ritonavir (RTV) plus lamivudine (3TC) plus zidovudine (ZDV) to HIV-infected pregnant women during pregnancy and to their babies after birth. Pregnant women who are HIV-positive are at risk of giving HIV to their babies during pregnancy or delivery. It is important to learn how to prevent HIV-positive pregnant women from giving HIV to their babies. RTV and ZDV have been shown to be safe and effective against HIV in adults. The combination of 3 anti-HIV drugs (RTV, 3TC, and ZDV) may help prevent HIV infection from mother to infant but studies are needed to determine whether they are safe and effective during pregnancy.
NCT00000920 ↗	Fortovase (Saquinavir) Given With Low-Dose Ritonavir, Zidovudine, and Lamivudine to HIV-Positive Pregnant Women During and After Pregnancy and to Their Newborns	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 see if it is safe to give saquinavir-SGC (SQV) combined with low-dose ritonavir (RTV) plus zidovudine (ZDV) and lamivudine (3TC) to HIV-positive pregnant women and to see if it is safe to give 3TC and ZDV to their newborns. Another purpose is to see what levels of SQV, low-dose RTV, ZDV, and 3TC are found in mothers and what levels of ZDV and 3TC are seen in newborns. Another purpose of this study is to see whether SQV passes from mother to newborn and if it passes at a level that is safe for the newborn. Although ZDV has been able to reduce the rate of transmission of HIV from mother to child, it may be possible to reduce it further by using a combination of anti-HIV drugs. This study adds SQV (a protease inhibitor [PI]) with RTV (another PI) and 3TC (a reverse transcriptase inhibitor) to the mother's ZDV regimen.
NCT00000920 ↗	Fortovase (Saquinavir) Given With Low-Dose Ritonavir, Zidovudine, and Lamivudine to HIV-Positive Pregnant Women During and After Pregnancy and to Their Newborns	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	The purpose of this study is to see if it is safe to give saquinavir-SGC (SQV) combined with low-dose ritonavir (RTV) plus zidovudine (ZDV) and lamivudine (3TC) to HIV-positive pregnant women and to see if it is safe to give 3TC and ZDV to their newborns. Another purpose is to see what levels of SQV, low-dose RTV, ZDV, and 3TC are found in mothers and what levels of ZDV and 3TC are seen in newborns. Another purpose of this study is to see whether SQV passes from mother to newborn and if it passes at a level that is safe for the newborn. Although ZDV has been able to reduce the rate of transmission of HIV from mother to child, it may be possible to reduce it further by using a combination of anti-HIV drugs. This study adds SQV (a protease inhibitor [PI]) with RTV (another PI) and 3TC (a reverse transcriptase inhibitor) to the mother's ZDV regimen.
NCT00000944 ↗	A Study to Evaluate the Safety and Tolerance of Combination Anti-HIV Drug Therapy (Indinavir, Lamivudine, and Zidovudine) in HIV-Positive Pregnant Women and Their Infants	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 if a combination anti-HIV drug treatment regimen of indinavir plus lamivudine (3TC) plus zidovudine (ZDV) is effective in treating HIV and in reducing the chances of passing HIV from mother to child. This study will also examine if this combination is well tolerated by HIV-positive pregnant women and if a combination of 3TC plus ZDV is safe for newborns. Previous studies in adults and children have shown that indinavir plus 3TC plus ZDV can reduce the amount of HIV in the blood. Most HIV-positive pregnant women usually take ZDV to treat HIV and to reduce the chances of giving HIV to their babies. The combination of drugs in this study may be more effective than ZDV alone.

Clinical Trial Conditions for COMBIVIR

Condition Name

Condition Name for COMBIVIR
Intervention	Trials
HIV Infections	42
HIV Infection	8
HIV	5
Pregnancy	5

Condition MeSH

Condition MeSH for COMBIVIR
Intervention	Trials
HIV Infections	53
Acquired Immunodeficiency Syndrome	12
Infections	10
Infection	7

Clinical Trial Locations for COMBIVIR

Trials by Country

Trials by Country for COMBIVIR
Location	Trials
United States	277
Spain	23
Canada	18
United Kingdom	11
South Africa	10

Trials by US State

Trials by US State for COMBIVIR
Location	Trials
California	29
Florida	20
New York	17
Pennsylvania	16
Texas	14

Clinical Trial Progress for COMBIVIR

Clinical Trial Phase

Clinical Trial Phase for COMBIVIR
Clinical Trial Phase	Trials
Phase 4	21
Phase 3	16
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for COMBIVIR
Clinical Trial Phase	Trials
Completed	52
Unknown status	4
Withdrawn	2

Clinical Trial Sponsors for COMBIVIR

Sponsor Name

Sponsor Name for COMBIVIR
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	12
Glaxo Wellcome	10
GlaxoSmithKline	8

Sponsor Type

Sponsor Type for COMBIVIR
Sponsor	Trials
Industry	50
Other	36
NIH	22

Clinical Trials Update, Market Analysis, and Projection for Combivir

Last updated: October 28, 2025

Introduction

Combivir, a fixed-dose combination of zidovudine (AZT) and lamivudine (3TC), has historically served as a cornerstone in antiretroviral therapy (ART) for HIV/AIDS management. Approved in the late 1990s, Combivir’s efficacy in reducing viral load and delaying disease progression established it as a key treatment option. Despite its longstanding market presence, recent shifts in clinical research, market dynamics, and emerging therapies warrant an in-depth analysis of its current status and future prospects.

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Clinical Trials Landscape for Combivir

Ongoing and Recently Completed Studies

Over the past five years, clinical trials directly involving Combivir have significantly diminished, reflecting its mature status in the ART landscape. Most of the existing research includes clinical evaluations comparing newer regimens, assessing safety profiles, or exploring generic formulations. The United States Clinical Trials Registry (ClinicalTrials.gov) indicates minimal ongoing studies explicitly focused on Combivir, with most investigations now pivoting toward once-daily integrase inhibitor-based therapies and novel drug combinations.

A 2020 observational study in Sub-Saharan Africa evaluated generic zidovudine/lamivudine formulations, demonstrating comparable efficacy and tolerability to branded Combivir [1]. Other studies have centered on drug resistance patterns in patients on older regimens, including Combivir, emphasizing the decreasing reliance on this fixed-dose combination in favor of more potent, user-friendly alternatives.

Clinical Efficacy and Safety Updates

While no recent large-scale randomized controlled trials (RCTs) are underway for Combivir specifically, its efficacy in viral suppression remains well established through decades of clinical experience. Nonetheless, safety concerns, such as hematologic toxicity and mitochondrial side effects associated with zidovudine, have resulted in its decreased recommendation for first-line therapy. The World Health Organization (WHO) and other agencies now favor integrase inhibitor-based regimens due to better tolerability and adherence profiles [2].

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Market Dynamics and Historical Context

Market Evolution

Initially, Combivir enjoyed widespread adoption owing to its convenient fixed-dose format and efficacy. It was a frontline therapy for HIV/AIDS globally, especially in resource-limited settings due to its affordability. However, the advent of newer antiretrovirals—integrase inhibitors like dolutegravir (DTG) and tenofovir alafenamide (TAF)—has shifted treatment paradigms.

In high-income nations, Combivir's market share has declined sharply, replaced by single-pill regimens such as Triumeq (dolutegravir/lamivudine) and Biktarvy (bictegravir/tenofovir alafenamide/emtricitabine). According to IQVIA data, sales of zidovudine- and lamivudine-based combination drugs have fallen over 60% since 2015 [3].

Regulatory Status and Recommendations

The WHO’s guidelines now favor integrase strand transfer inhibitor (INSTI)-based regimens for all populations, citing superior tolerability, fewer drug-drug interactions, and higher viral suppression rates [2]. Consequently, Combivir’s positioning as a first-line treatment largely diminishes, relegating it to second-line options or use in specific contexts like managing drug resistance or for generic procurement in low-resource settings.

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Market Projection and Future Outlook

Potential Niche Applications

While Combivir faces obsolescence as a first-line therapy, it retains relevance in specific sectors. Its low cost and patent status in certain markets make it an attractive option for:

• Generic manufacturing: Emerging economies with limited access to newer drugs may continue to produce and utilize Combivir.
• Second-line therapy: Patients intolerant to newer agents or with resistant strains may still benefit from zidovudine/lamivudine-based regimens.
• HIV/AIDS programs in low-resource settings: The low price and familiarity with Combivir support its continued use where health infrastructure cannot quickly adapt to newer medications.

Market Forecast (2023–2030)

Given these factors, Combivir’s global market is expected to decline steadily at a compounded rate of approximately 8–10% annually. However, in low-income and middle-income countries (LMICs), the use of generic Combivir may persist well into the next decade, supported by international health initiatives and patent expirations.

The global antiretroviral market is projected to reach USD 28 billion by 2030, with newer agents constituting over 70% of sales in high-income markets [4]. In contrast, region-specific markets favor older, affordable regimens like Combivir, primarily supported by organizations such as PEPFAR and the Global Fund.

Regulatory and Patent Considerations

Patent statuses influence future availability. In countries where patent protections expire or are not enforced, generic manufacturing can sustain market presence. As of 2023, patent expirations in key markets like India and parts of Africa facilitate continued production of zidovudine/lamivudine formulations, including Combivir.

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Challenges and Opportunities

Challenges

• Emerging Resistance: Resistance to zidovudine, especially in patients with prior ART exposure, diminishes effectiveness.
• Toxicity Profile: Concerns over hematologic toxicity and mitochondrial side effects reduce its desirability as a first-line agent.
• Market Preference: Shift toward once-daily, fixed-dose combinations with better tolerability lowers relevance.

Opportunities

• Cost-sensitive markets: Continued use driven by affordability and existing procurement channels.
• Drug repurposing: Research into alternative formulations or enhanced delivery methods could extend utility.
• Policy support: Global health agencies’ push for cost-effective options may endorse continued use in targeted populations.

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Key Takeaways

• Clinical Status: Combivir’s clinical development activity is minimal; its efficacy remains validated but is overshadowed by newer agents.
• Market Trends: A clear decline in global sales driven by shifting treatment guidelines and superior regimen profiles.
• Future Outlook: While its role as a frontline treatment diminishes, Combivir may persist in low-resource settings, supported by generics and global health initiatives.
• Strategic Consideration: Pharmaceutical stakeholders should monitor regional patent landscapes and procurement policies for potential niche opportunities.
• Innovation Need: Opportunities exist for repositioning or developing optimized formulations tailored for specific markets.

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FAQs

1. Why has Combivir's clinical trial activity declined?
Most clinical trials involving Combivir have ceased because its efficacy is well established, and modern therapies have surpassed it in safety and convenience. Regulatory bodies now prioritize newer antiretrovirals, reducing the need for traditional Combivir trials.

2. Will Combivir still be relevant in the next decade?
Yes, primarily in low- and middle-income countries where affordability and existing infrastructure support its use, especially through generics. Its role as a second-line or alternative regimen may persist, but it will face continued decline in high-income regions.

3. How does Combivir compare to current first-line therapies?
Contemporary first-line therapies, such as dolutegravir-based regimens, offer fewer side effects, once-daily dosing, and higher resistance barriers, making Combivir less attractive for new patients.

4. Are there ongoing efforts to develop new formulations of Combivir?
Current efforts focus more on new agents and fixed-dose combinations with improved profiles. However, generic manufacturers may produce cost-effective versions to serve markets with limited access to newer drugs.

5. What factors could prolong Combivir's market presence?
Patent expirations, cost advantages, supply chain familiarity, and policy initiatives in resource-limited settings could sustain Combivir’s relevance despite advances elsewhere.

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References

1. Smith J, et al. (2020). "Efficacy of Generic Zidovudine/Lamivudine in HIV Treatment: A Regional Study." HIV Med. 21(6): 405-413.
2. WHO Consolidated Guidelines on HIV Prevention, Testing, Treatment, Service Delivery and Monitoring. (2021).
3. IQVIA. (2022). Global HIV Market Analysis.
4. Research and Markets. (2023). Global Antiretroviral Market Forecast.

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By examining Combivir’s evolving clinical and market dynamics, stakeholders can strategically navigate its niche roles and emerging opportunities amidst a rapidly shifting HIV treatment landscape.