CLINICAL TRIALS PROFILE FOR LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE

All Clinical Trials for Lamivudine; Nevirapine; Zidovudine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000896 ↗	A Study to Compare the Effectiveness of a Four Drug Anti-HIV Regimen Given Alone or in Combination With GM-CSF or IL-12 to HIV-Positive Patients	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	The purpose of this study is to examine how the level of HIV is reduced in the blood when anti-HIV therapy is initiated. This study will also evaluate whether adding GM-CSF or IL-12 to the anti-HIV drug regimen will increase the rate that HIV is reduced. The anti-HIV drugs used in this study will include lamivudine (3TC), zidovudine (ZDV), indinavir (IDV), nevirapine (NVP), and stavudine (d4T). All have been used successfully to treat HIV. GM-CSF has been used to treat certain blood disorders; it will be used as an experimental drug in this study. IL-12 (interleukin-12) is a protein found naturally in the body that is thought to boost the immune system. Although GM-CSF and IL-12 have no direct effect against HIV, these drugs may improve the ability of the immune system to fight the virus.
NCT00000902 ↗	A Study on the Management of Combination Anti-HIV Drug Therapy in HIV-Positive Children With Prior Treatment	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	The purpose of this study is to determine the value of changing anti-HIV medications in children with progressive HIV disease who have received previous treatment. Plasma viral load (the level of HIV in the blood) is probably most effectively reduced by giving patients anti-HIV drugs which affect the virus at various stages of development. Changing the medications may enhance the results of treatment.
NCT00001083 ↗	Comparison of New Anti-HIV Drug Combinations in HIV-Infected Children Who Have Taken Anti-HIV Drugs	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	For PRAM-1: To evaluate zidovudine (ZDV) + lamivudine (3TC) vs. stavudine (d4T) + ritonavir vs. ZDV + 3TC + ritonavir with respect to the change in plasma HIV-1 RNA copy number from baseline to 48 weeks [AS PER AMENDMENT 1/5/98: 72 weeks; AS PER AMENDMENT 7/17/98: 48 weeks] in stable HIV-infected children with >= 16 weeks of prior continuous antiretroviral therapy. To evaluate the safety and tolerance of ZDV + 3TC vs. d4T + ritonavir vs. ZDV + 3TC + ritonavir based upon laboratory and clinical toxicities. AS PER AMENDMENT 10/20/97: For PRAM-1, Step 2: To evaluate d4T + nevirapine + ritonavir with respect to change in plasma HIV-1 RNA copy number from baseline to 48 weeks in children who have received at least 12 weeks of therapy on the PRAM-1 ZDV/3TC arm and have over 10,000 viral copies at weeks 12, 24, or 36. To evaluate the safety and tolerance of d4T + nevirapine + ritonavir based upon laboratory and clinical toxicities. [AS PER AMENDMENT 10/23/98: To evaluate safety and tolerance of a switch from d4T + ritonavir vs. ZDV + 3TC + ritonavir to d4T + indinavir vs. ZDV + 3TC + indinavir in stable, HIV-infected children with RNA values <= 10,000 copies/ml.] For PRAM-1: Evidence supports combination therapy with 2 or more antiviral agents as beneficial in the long-term management of HIV. The possibility exists that combination therapy may result in a synergistic or additive activity over a prolonged period of time. Also hypothesized is that the development of resistance to individual agents will be developed if viral replication is significantly decreased. AS PER AMENDMENT 10/20/97: For PRAM-1, Step 2: Interim analysis at 12 weeks on PRAM-1 indicates that the proportion of children reaching undetectable RNA levels on the ZDV + 3TC arm is significantly less than the other two arms. The protocol, therefore, has been modified (Step 2) to permit children in the ZDV + 3TC arm with RNA copy number >= 10,000 the opportunity to change to a novel therapeutic regimen (d4T + nevirapine + ritonavir).

Clinical Trial Conditions for Lamivudine; Nevirapine; Zidovudine

Condition Name

Condition Name for Lamivudine; Nevirapine; Zidovudine
Intervention	Trials
HIV Infections	29
HIV	8
HIV Infection	2

Condition MeSH

Condition MeSH for Lamivudine; Nevirapine; Zidovudine
Intervention	Trials
HIV Infections	32
Acquired Immunodeficiency Syndrome	7
Infections	6

Clinical Trial Locations for Lamivudine; Nevirapine; Zidovudine

Trials by Country

Trials by Country for Lamivudine; Nevirapine; Zidovudine
Location	Trials
United States	132
South Africa	15
Thailand	10
India	9
Canada	7

Trials by US State

Trials by US State for Lamivudine; Nevirapine; Zidovudine
Location	Trials
California	10
New York	8
Florida	8
North Carolina	7
Massachusetts	7

Clinical Trial Progress for Lamivudine; Nevirapine; Zidovudine

Clinical Trial Phase

Clinical Trial Phase for Lamivudine; Nevirapine; Zidovudine
Clinical Trial Phase	Trials
Phase 4	9
Phase 3	14
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for Lamivudine; Nevirapine; Zidovudine
Clinical Trial Phase	Trials
Completed	39
Unknown status	3
Terminated	2

Clinical Trial Sponsors for Lamivudine; Nevirapine; Zidovudine

Sponsor Name

Sponsor Name for Lamivudine; Nevirapine; Zidovudine
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	17
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	9
Boehringer Ingelheim	4

Sponsor Type

Sponsor Type for Lamivudine; Nevirapine; Zidovudine
Sponsor	Trials
Other	55
NIH	28
Industry	13

Clinical Trials Update, Market Analysis, and Projections for Lamivudine, Nevirapine, and Zidovudine

Introduction

Lamivudine, Nevirapine, and Zidovudine are cornerstone antiretroviral drugs used in the treatment of HIV-1 infection. This article provides an update on the current clinical trials, market analysis, and future projections for these medications.

Clinical Trials Update

Lamivudine

Lamivudine, often used in combination with other antiretroviral drugs, has been a subject of various clinical trials to optimize its dosing and efficacy.

• Dolutegravir/Lamivudine Combination: Recent studies, such as the TANGO and SALSA trials, have demonstrated the high efficacy and safety of the two-drug regimen dolutegravir/lamivudine (DTG/3TC) in adults who are virologically suppressed. This regimen is recommended by international guidelines as an initial antiretroviral therapy (ART) and as a switch option for those already on treatment[1].
• Preterm Infants: A recent study focused on developing a pragmatic twice-daily lamivudine dosing strategy for preterm infants. The model-based predictions suggest optimal dosing strategies based on gestational age, which need clinical validation[4].

Nevirapine

Nevirapine, a non-nucleoside reverse transcriptase inhibitor (NNRTI), continues to be evaluated in various clinical contexts.

• Combination Therapies: Nevirapine has been shown to exhibit additive to synergistic anti-HIV-1 activity when combined with other antiretroviral drugs, including protease inhibitors and nucleoside reverse transcriptase inhibitors (NRTIs)[3].
• Resistance and Cross-Resistance: Studies have highlighted the rapid emergence of Nevirapine-resistant HIV-1 strains and their cross-resistance to other NNRTIs, such as delavirdine and efavirenz[3].

Zidovudine

Zidovudine, one of the earliest approved antiretroviral drugs, remains a component of some treatment regimens.

• Combination Therapies: Zidovudine is often used in combination with other NRTIs, such as lamivudine. These combinations have been shown to restore phenotypic sensitivity to zidovudine in some patients harboring zidovudine-resistant virus[3].
• Resistance and Cross-Resistance: Long-term use of zidovudine can lead to the emergence of multi-drug resistant HIV-1 isolates. Cross-resistance between zidovudine and other NRTIs, such as didanosine and stavudine, has been observed[3].

Market Analysis

Global HIV Clinical Trials Market

The global HIV clinical trials market is experiencing significant growth driven by several factors:

• Increasing R&D Investment: Pharmaceutical and biotechnology companies are investing heavily in HIV clinical trials, driving innovation in treatments and vaccines[2].
• Growing Incidence of HIV: The rising incidence of HIV globally is increasing the demand for effective treatments, which in turn fuels the clinical trials market[2].
• Regional Growth: North America, particularly the U.S., dominates the HIV clinical trials market due to high R&D spending, government support, and the presence of major pharmaceutical companies. The Asia Pacific region is also expected to grow rapidly due to cost-efficiency and technological advancements[2].

Market Size and Projections

• 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[2].
• The broader clinical trials market, which includes trials for various diseases, was valued at USD 84.61 billion in 2024 and is expected to reach USD 146.60 billion by 2033, growing at a CAGR of 6.07% during the forecast period[5].

Innovations and Trends

Long-Acting Therapies

There is a growing focus on developing long-acting antiretroviral therapies to improve treatment adherence and reduce treatment fatigue. For instance, the PAUSE study announced by ACTG in 2024 aims to evaluate two long-acting neutralizing antibodies in a structured treatment interruption study[2].

Personalized Medicine

The use of pharmacogenomics to optimize treatment regimens based on individual genetic profiles is becoming more prevalent. This approach helps in improving patient outcomes and reducing the incidence of drug resistance[2].

Digital Health Technologies

The integration of digital health technologies is enhancing the efficiency and accessibility of clinical trials. This trend is particularly notable in regions like the UK, where it is driving market growth[2].

Regulatory and Funding Support

Government Initiatives

Government support and funding are crucial for the advancement of HIV clinical trials. For example, the National Institutes of Health (NIH) has initiated preventive clinical trials for HIV vaccine candidates in the U.S. and South Africa[2].

FDA Approvals and Funding

The U.S. FDA has approved several clinical trial research initiatives with significant funding, aiming to support the development of new medical products for treating rare diseases, including HIV[2].

Key Takeaways

• Efficacy and Safety: The combination of dolutegravir/lamivudine has shown high efficacy and a good safety profile, making it a recommended regimen for HIV treatment.
• Market Growth: The global HIV clinical trials market is expected to grow significantly, driven by R&D investments, increasing incidence of HIV, and advancements in long-acting therapies and personalized medicine.
• Regional Dynamics: North America, particularly the U.S., and the Asia Pacific region are key drivers of the HIV clinical trials market due to their robust healthcare infrastructure and research activities.
• Innovations: The focus on long-acting therapies, personalized medicine, and digital health technologies is set to transform the landscape of HIV treatment.

FAQs

What is the current status of the dolutegravir/lamivudine combination in HIV treatment?

The dolutegravir/lamivudine combination has been shown to be highly effective and safe in clinical trials, such as the TANGO and SALSA trials, and is recommended by international guidelines as an initial ART regimen and as a switch option for those already on treatment[1].

How is lamivudine dosing optimized for preterm infants?

Recent studies suggest a pragmatic twice-daily lamivudine dosing strategy for preterm infants based on gestational age, which needs clinical validation to ensure optimal drug exposure[4].

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

The market is driven by increasing R&D investments, the growing incidence of HIV, advancements in long-acting therapies, and personalized medicine, as well as government support and funding[2].

Which regions are expected to see significant growth in the HIV clinical trials market?

North America, particularly the U.S., and the Asia Pacific region are expected to drive market growth due to their robust healthcare infrastructure, high R&D spending, and technological advancements[2].

How is personalized medicine impacting HIV treatment?

Personalized medicine, using pharmacogenomics to optimize treatment regimens based on individual genetic profiles, is improving patient outcomes and reducing the incidence of drug resistance[2].

Sources

1. Observations from this pooled analysis demonstrate the high efficacy and barrier to resistance, as well as the good safety profile, of dolutegravir/lamivudine (DTG/3TC) using pooled data from the TANGO and SALSA trials in adults who were virologically suppressed with or without historical resistance results at screening. [Oxford Academic][1]
2. The global HIV clinical trials market size was estimated at USD 1.56 billion in 2024 and is projected to grow at a CAGR of 5.8% from 2025 to 2030. [Grand View Research][2]
3. Lamivudine, Nevirapine, and Zidovudine: The antiviral activity of these drugs has been measured in various cell lines, and their use in combination therapies has been evaluated for efficacy and resistance. [FDA][3]
4. Model-based predictions support twice daily pragmatic GA band dosing of lamivudine for preterm infants, but clinical validation is warranted. [PubMed][4]
5. The global clinical trials market size was valued at USD 84.61 billion in 2024 and is projected to reach USD 146.60 billion by 2033, growing at a CAGR of 6.07% during the forecast period. [Straits Research][5]

Last updated: 2025-01-02