CLINICAL TRIALS PROFILE FOR RETROVIR

All Clinical Trials for Retrovir

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000662 ↗	A Treatment IND for Retrovir Brand Zidovudine (AZT) Therapy of Pediatric Patients With HIV Disease	Completed	Glaxo Wellcome	N/A	1969-12-31	To facilitate the use of zidovudine (AZT) in children who are 3 months to 12 years of age who are HIV-infected and either symptomatic or have a CD4 cell count < 400 cells/mm3 and to monitor adverse effects of AZT. Previous studies with pediatric patients have shown improvements in clinical, immunologic, and virologic parameters with administration of AZT.
NCT00000662 ↗	A Treatment IND for Retrovir Brand Zidovudine (AZT) Therapy of Pediatric Patients With HIV Disease	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	To facilitate the use of zidovudine (AZT) in children who are 3 months to 12 years of age who are HIV-infected and either symptomatic or have a CD4 cell count < 400 cells/mm3 and to monitor adverse effects of AZT. Previous studies with pediatric patients have shown improvements in clinical, immunologic, and virologic parameters with administration of AZT.
NCT00000716 ↗	A Multicenter Trial To Evaluate Oral Retrovir in the Treatment of Children With Symptomatic HIV Infection	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	To evaluate the safety and tolerance of oral zidovudine (AZT) when given over a period of 24 weeks to children between 3 months and 12 years of age. The effectiveness of AZT in treating HIV infection in infants and children will also be evaluated. HIV infection in children is most often associated with symptomatic disease and poor prognosis. Treatment with antiviral therapy may be effective in altering the course of the disease and decreasing mortality in these children. AZT has been shown to be effective in certain adult patients with symptomatic HIV infection. It is therefore likely that infected children may also benefit from this treatment.
NCT00002020 ↗	Trial of an Alternative Dosing Regimen of Oral Retrovir in Patients With AIDS or Advanced ARC	Completed	Glaxo Wellcome	N/A	1969-12-31	To evaluate the safety and tolerance, in patients with severe clinical manifestations of HIV infection, of zidovudine (AZT) administered daily for 48 weeks as a low dose every 4 hours or a higher dose every 12 hours.
NCT00002028 ↗	A Treatment IND (Investigational New Drug) Protocol for the Use of Videx (2',3'-Dideoxyinosine, ddI) in Patients With Acquired Immunodeficiency Syndrome (AIDS) or AIDS- Related Complex (ARC) Who Are Intolerant to Zidovudine (Retrovir)	Completed	Bristol-Myers Squibb	N/A	1969-12-31	The objective of this treatment IND protocol is to make didanosine (ddI) available to patients with HIV infection (suffering from AIDS related complex (ARC) or AIDS) who have developed documented intolerance to zidovudine (AZT) and cannot enter a Phase II ddI program due to protocol exclusion or geographic location.
NCT00002044 ↗	A Pilot Study To Evaluate the Effect of Retrovir (Zidovudine: AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Associated Dementia and Neuromuscular Diseases	Completed	Glaxo Wellcome	N/A	1969-12-31	The purpose of this pilot study is to evaluate the efficacy of Retrovir (AZT) in the treatment of AIDS-related dementia and various neuromuscular complications. HIV is both a lymphotropic and neurotropic virus which can affect both the central and peripheral nervous systems (CNS, PNS). There is evidence that the CNS and PNS may harbor the virus in a latent state, with the potential for continuous reinfection of other body systems. Therefore, effective therapeutic efforts against HIV infection should provide effective antiviral activity within the nervous system.

Clinical Trial Conditions for Retrovir

Condition Name

Condition Name for Retrovir
Intervention	Trials
HIV Infections	36
HIV	4
Healthy	2
Lymphoma	2

Condition MeSH

Condition MeSH for Retrovir
Intervention	Trials
HIV Infections	38
Acquired Immunodeficiency Syndrome	19
Infections	12
Infection	11

Clinical Trial Locations for Retrovir

Trials by Country

Trials by Country for Retrovir
Location	Trials
United States	139
South Africa	11
Puerto Rico	6
Brazil	6
Zimbabwe	5

Trials by US State

Trials by US State for Retrovir
Location	Trials
Texas	12
Florida	11
California	11
North Carolina	11
New York	9

Clinical Trial Progress for Retrovir

Clinical Trial Phase

Clinical Trial Phase for Retrovir
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	6
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Retrovir
Clinical Trial Phase	Trials
Completed	45
Terminated	2
Recruiting	1

Clinical Trial Sponsors for Retrovir

Sponsor Name

Sponsor Name for Retrovir
Sponsor	Trials
Glaxo Wellcome	15
National Institute of Allergy and Infectious Diseases (NIAID)	11
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	6

Sponsor Type

Sponsor Type for Retrovir
Sponsor	Trials
Industry	30
NIH	25
Other	17

Clinical Trials, Market Analysis, and Projections for Antiretroviral Drugs: A Focus on Emerging Therapies

Last updated: January 2, 2025

Introduction

The landscape of antiretroviral drugs is evolving rapidly, driven by advancements in clinical trials, market demand, and the ongoing need for effective treatments for HIV. This article will delve into the latest clinical trial updates, market analysis, and projections, with a particular focus on emerging therapies like the doravirine/islatravir (DOR/ISL) regimen.

Clinical Trials Update: Doravirine/Islatravir (DOR/ISL)

Phase 3 Trials Results

Merck recently announced topline results from two pivotal Phase 3 trials evaluating the investigational once-daily, oral, two-drug, single-tablet regimen of doravirine/islatravir (DOR/ISL) for adults with virologically suppressed HIV-1 infection. These trials, MK-8591A-051 and MK-8591A-052, demonstrated that DOR/ISL met the efficacy success criteria for non-inferiority compared to comparator antiretroviral therapies. The safety profiles of DOR/ISL were generally comparable to other therapies in these trials[1].

Ongoing and Future Trials

In addition to the completed trials, ongoing Phase 3 trials include MK-8591A-053, which is evaluating DOR/ISL in treatment-naïve individuals, and MK-8591A-054, an open-label study in participants who previously received DOR/ISL. These trials are crucial for expanding the understanding and application of this regimen[1].

Market Analysis of Antiretroviral Drugs

Current Market Size and Growth

The global anti-retroviral drugs market was valued at USD 29.1 billion in 2023 and is anticipated to grow at a CAGR of 4.2% from 2024 to 2032. This growth is driven by increased investment in research and development, the emergence of generic drug alternatives, and the advent of novel drugs with enhanced efficacy[2].

Market Segmentation

The market is segmented by product, type, age group, and distribution channel. Multi-class combination products dominate the market, with the branded segment holding the highest business share. The adult segment is expected to hold the highest revenue throughout the forecast period, and hospital pharmacies currently hold the largest share of the distribution channel[2].

Regional Dynamics

North America secures a substantial market share and is expected to dominate throughout the forecast period due to the presence of key market players, technological advancements, and a high number of HIV cases. The Asia Pacific region is also expected to grow significantly, driven by the cost-efficiency of conducting clinical trials and evolving business models of outsourcing and R&D activities[2][5].

HIV Clinical Trials Market

Market Size and Growth

The global HIV clinical trials market was estimated at USD 1.56 billion in 2024 and is projected to grow at a CAGR of 5.8% from 2025 to 2030. This growth is driven by increasing drug approvals, rising R&D investment, and the growing incidence of HIV[3].

Phase I Clinical Trials

The Phase I segment is anticipated to register a significant CAGR due to increasing research and development investments. The globalization of clinical trials and the growing requirement for HIV Phase I clinical trials are key drivers of this segment[3].

Regional Focus

The U.S. accounts for the highest share of the North America HIV clinical trials market, driven by high R&D spending and support from government and regulatory authorities. The UK market is driven by digital health technologies, outsourcing trends, and growing drug innovation. Asia Pacific is expected to grow at a CAGR of 7.63% due to cost-efficiency and technological advancements[3].

Emerging Trends and Innovations

Long-Acting Therapies

There is a growing emphasis on long-acting therapies and precision medicines to improve treatment adherence and patient outcomes. For instance, the PAUSE study evaluating long-acting neutralizing antibodies is a significant example of innovative approaches in HIV treatment[3].

Personalized Medicine

The industry is moving towards personalized medicine, using pharmacogenomics to optimize treatment regimens based on individual genetic profiles. This approach aims to enhance the efficacy and safety of antiretroviral therapies[3].

Impact of COVID-19 on the Market

Initial Surge and Subsequent Normalization

The COVID-19 pandemic initially surged the demand for antiretroviral drugs due to their potential use in treating COVID-19. However, with the decrease in COVID-19 cases due to increased vaccination and the availability of other COVID-19 treatments, the market has normalized. Despite this, the market is expected to maintain favorable growth due to the ongoing need for treatments against other retrovirus infections[5].

Key Players and Competitive Landscape

Strategic Initiatives

Key players in the anti-retroviral drugs market are engaging in strategic initiatives such as mergers, acquisitions, and partnerships to strengthen their product portfolios. Companies like Merck are committed to advancing clinical programs for new antiretrovirals, such as islatravir, to address the needs of people living with HIV[1][2].

Conclusion

The anti-retroviral drugs market is poised for significant growth, driven by advancements in clinical trials, increasing R&D investments, and the growing incidence of HIV. Emerging therapies like the doravirine/islatravir regimen offer promising alternatives for treating HIV, with a focus on once-daily, oral, two-drug regimens that enhance patient compliance and outcomes.

Key Takeaways

• Clinical Trials Success: The doravirine/islatravir regimen has shown non-inferiority to comparator antiretroviral therapies in Phase 3 trials.
• Market Growth: The global anti-retroviral drugs market is expected to grow at a CAGR of 4.2% from 2024 to 2032.
• Regional Dynamics: North America and the Asia Pacific region are key markets due to their high demand and cost-efficiency in clinical trials.
• Innovations: Long-acting therapies and personalized medicine are emerging trends in HIV treatment.
• COVID-19 Impact: The market normalized after the initial surge during the pandemic but is expected to maintain growth.

FAQs

What are the recent clinical trial results for the doravirine/islatravir (DOR/ISL) regimen?

The recent Phase 3 trials (MK-8591A-051 and MK-8591A-052) have shown that DOR/ISL met the efficacy success criteria for non-inferiority compared to comparator antiretroviral therapies, with safety profiles generally comparable to other therapies[1].

How is the anti-retroviral drugs market expected to grow?

The global anti-retroviral drugs market is anticipated to grow at a CAGR of 4.2% from 2024 to 2032, driven by increased investment in R&D, the emergence of generic and novel drugs, and the growing incidence of HIV[2].

What are the key drivers of the HIV clinical trials market?

The HIV clinical trials market is driven by increasing drug approvals, rising R&D investment, and the growing incidence of HIV. The market is also influenced by the globalization of clinical trials and the growing requirement for Phase I clinical trials[3].

How has the COVID-19 pandemic impacted the anti-retroviral drugs market?

The COVID-19 pandemic initially surged the demand for antiretroviral drugs but has since normalized as COVID-19 cases decreased. The market is expected to maintain favorable growth due to the ongoing need for treatments against other retrovirus infections[5].

What are the emerging trends in HIV treatment?

Emerging trends include the development of long-acting therapies, precision medicines, and personalized treatment regimens based on individual genetic profiles[3].

Which regions are expected to dominate the anti-retroviral drugs market?

North America is expected to dominate the market due to the presence of key players and high R&D spending. The Asia Pacific region is also expected to grow significantly due to cost-efficiency and technological advancements[2][5].

Sources

1. Merck Announces Topline Results from Pivotal Phase 3 Trials Evaluating Investigational, Once-Daily, Oral, Two-Drug, Single-Tablet Regimen of Doravirine/Islatravir (DOR/ISL) for the Treatment of Adults with Virologically Suppressed HIV-1 Infection. Merck.
2. Anti-retroviral Drugs Market Size & Share – Trends Report, 2032. Grand View Insights.
3. HIV Clinical Trials Market Size, Share | Industry Report, 2030. Grand View Research.
4. Efficacy and safety of dolutegravir or darunavir in combination with .... The Lancet.
5. Anti-Retroviral Drugs Market Size & Share Analysis - Growth Trends. Mordor Intelligence.