CLINICAL TRIALS PROFILE FOR SUSTIVA

505(b)(2) Clinical Trials for Sustiva

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT00002234 ↗	Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients	Completed	Bristol-Myers Squibb	Phase 2	1969-12-31	The purpose of this study is to see if it is safe and effective to give HIV-infected patients a new combination of anti-HIV drugs taken once daily.
New Combination	NCT00002234 ↗	Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients	Completed	Dupont Applied Biosciences	Phase 2	1969-12-31	The purpose of this study is to see if it is safe and effective to give HIV-infected patients a new combination of anti-HIV drugs taken once daily.
New Combination	NCT00002234 ↗	Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients	Completed	Glaxo Wellcome	Phase 2	1969-12-31	The purpose of this study is to see if it is safe and effective to give HIV-infected patients a new combination of anti-HIV drugs taken once daily.
New Combination	NCT00002234 ↗	Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients	Completed	Gilead Sciences	Phase 2	1969-12-31	The purpose of this study is to see if it is safe and effective to give HIV-infected patients a new combination of anti-HIV drugs taken once daily.

All Clinical Trials for Sustiva

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001758 ↗	Continued Antiretroviral Therapy With Abacavir, Amprenavir and Efavirenz	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1997-11-01	This study will continue to treat and collect safety and efficacy data on patients who participated in Glaxo-Wellcome's multi-center study on combination therapy with abacavir, amprenavir and efavirenz (A Phase II Study Evaluating the Safety and Antiviral Activity of Combination Therapy with 1592U89, 141W94 and DMP 266 (Sustiva) in HIV-1 Infected Subjects with Detectable [greater than 400 Copies/mL] HIV-1 Plasma RNA Despite Treatment with a Protease Inhibitor-Containing Regimen). HIV-infected patients 18 years of age and older who participated in the above study at the NIH site may be eligible for the current study. Participants will be followed every 3 months with a general health evaluation and laboratory tests. This is a NIH study, and information will not be provided to Glaxo Wellcome
NCT00002234 ↗	Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients	Completed	Bristol-Myers Squibb	Phase 2	1969-12-31	The purpose of this study is to see if it is safe and effective to give HIV-infected patients a new combination of anti-HIV drugs taken once daily.
NCT00002234 ↗	Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients	Completed	Dupont Applied Biosciences	Phase 2	1969-12-31	The purpose of this study is to see if it is safe and effective to give HIV-infected patients a new combination of anti-HIV drugs taken once daily.
NCT00002234 ↗	Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients	Completed	Glaxo Wellcome	Phase 2	1969-12-31	The purpose of this study is to see if it is safe and effective to give HIV-infected patients a new combination of anti-HIV drugs taken once daily.
NCT00002234 ↗	Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients	Completed	Gilead Sciences	Phase 2	1969-12-31	The purpose of this study is to see if it is safe and effective to give HIV-infected patients a new combination of anti-HIV drugs taken once daily.
NCT00002235 ↗	A Study on the Safety and Effectiveness of Twice-Daily Nelfinavir Plus Twice-Daily Indinavir Plus Efavirenz in HIV-Positive Patients Who Have Never Taken Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) or Protease Inhibitors	Completed	Agouron Pharmaceuticals	Phase 2	1969-12-31	Indinavir is usually taken three times a day. The purpose of this study is to see if it is safe and effective to take indinavir only twice a day plus nelfinavir (also taken twice a day) and efavirenz (taken once a day).
NCT00002235 ↗	A Study on the Safety and Effectiveness of Twice-Daily Nelfinavir Plus Twice-Daily Indinavir Plus Efavirenz in HIV-Positive Patients Who Have Never Taken Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) or Protease Inhibitors	Completed	Merck Sharp & Dohme Corp.	Phase 2	1969-12-31	Indinavir is usually taken three times a day. The purpose of this study is to see if it is safe and effective to take indinavir only twice a day plus nelfinavir (also taken twice a day) and efavirenz (taken once a day).

Clinical Trial Conditions for Sustiva

Condition Name

Condition Name for Sustiva
Intervention	Trials
HIV Infections	36
HIV	11
HIV Infection	8
Healthy	5

Condition MeSH

Condition MeSH for Sustiva
Intervention	Trials
HIV Infections	47
Acquired Immunodeficiency Syndrome	9
Infections	9
Infection	8

Clinical Trial Locations for Sustiva

Trials by Country

Trials by Country for Sustiva
Location	Trials
United States	145
Spain	29
Canada	8
South Africa	6
Puerto Rico	6

Trials by US State

Trials by US State for Sustiva
Location	Trials
California	18
New York	11
District of Columbia	10
Texas	9
Florida	8

Clinical Trial Progress for Sustiva

Clinical Trial Phase

Clinical Trial Phase for Sustiva
Clinical Trial Phase	Trials
Phase 4	19
Phase 3	7
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Sustiva
Clinical Trial Phase	Trials
Completed	55
Unknown status	4
Terminated	3

Clinical Trial Sponsors for Sustiva

Sponsor Name

Sponsor Name for Sustiva
Sponsor	Trials
Bristol-Myers Squibb	8
National Institute of Allergy and Infectious Diseases (NIAID)	6
Abbott	5

Sponsor Type

Sponsor Type for Sustiva
Sponsor	Trials
Other	76
Industry	44
NIH	15

SUSTIVA: Clinical Trials, Market Analysis, and Projections

Introduction

SUSTIVA, also known as efavirenz, is a non-nucleoside reverse transcriptase inhibitor (NNRTI) used in the treatment of HIV-1 infection. Here, we will delve into the clinical trials, market analysis, and projections for this drug.

Clinical Trials Overview

Adverse Reactions and Safety Profile

Clinical trials have extensively evaluated the safety profile of SUSTIVA. In controlled trials, patients treated with SUSTIVA experienced a range of adverse reactions. Notably, central nervous system symptoms were reported by 53% of patients, including severe depression, suicidal ideation, non-fatal suicide attempts, aggressive behavior, paranoid reactions, and manic reactions[1][4].

• Psychiatric Symptoms: Serious psychiatric adverse experiences such as severe depression (2.4% vs 0.9% in control groups), suicidal ideation (0.7% vs 0.3%), and non-fatal suicide attempts (0.5% vs 0%) were observed. Other psychiatric symptoms included aggressive behavior, paranoid reactions, and manic reactions[1][4].
• Long-term Safety: Long-term data from these trials showed that beyond 24 weeks of therapy, the incidence of new-onset nervous system symptoms among SUSTIVA-treated patients was generally similar to those in the control arm[1].

Efficacy and Treatment Outcomes

SUSTIVA has been evaluated in various clinical settings to assess its efficacy. For instance, in Study AI266-006, SUSTIVA was combined with other antiretroviral drugs like zidovudine and lamivudine or indinavir. The results indicated that SUSTIVA-containing regimens were effective in maintaining viral suppression over extended periods[1][4].

Market Analysis

Global Market Assessment

The global market for HIV drugs, including SUSTIVA, has seen significant growth. Here are some key points:

• Market Size: The global HIV drugs market was valued at $34.13 billion in 2023 and is projected to grow to $58.24 billion by 2032, with a CAGR of 6.2% during the forecast period (2024-2032)[5].
• Regional Dominance: North America, particularly the U.S., dominates the market due to the high prevalence of HIV infection and the presence of key players like ViiV Healthcare and Gilead Sciences Inc.[5].

Market Segmentation

The HIV drugs market is segmented based on product type and distribution channels.

• Product Type: Combination HIV medicines, which include drugs like SUSTIVA, are expected to lead the market during the forecast period. Other segments include protease inhibitors, fusion inhibitors, CCR5 antagonists, and more[5].
• Distribution Channels: Hospital pharmacies are projected to hold the dominant share due to the increasing patient visits for HIV treatment and the high sales of prescribed antiretroviral drugs from these pharmacies[5].

Market Projections

Growth Drivers

Several factors are driving the growth of the HIV drugs market, including SUSTIVA:

• Increasing Patient Population: The rising number of individuals living with HIV globally is a significant driver. For example, in the U.S., approximately 1.2 million individuals were living with HIV as of 2018[5].
• New Product Launches: The introduction of new and innovative HIV treatments, such as the 2-drug regimen Dovato (dolutegravir/lamivudine), which has shown non-inferior efficacy compared to 3-drug regimens, is also driving market growth[3].
• Government Awareness Programs: Increased awareness and government-run programs have contributed to higher demand for HIV drugs[5].

Challenges and Opportunities

Despite the growth, the market faces challenges:

• COVID-19 Impact: The pandemic disrupted the supply of drugs and reduced new patient prescriptions, affecting market growth temporarily[5].
• Emerging Therapies: The development of new therapies, such as those from ViiV Healthcare, presents opportunities for market expansion. For instance, the PASO DOBLE trial demonstrated the efficacy of a 2-drug regimen, which could optimize treatment and reduce side effects like weight gain[3].

Key Takeaways

• Clinical Trials: SUSTIVA has been associated with significant psychiatric and nervous system adverse reactions, but it remains effective in long-term viral suppression.
• Market Size and Growth: The global HIV drugs market, including SUSTIVA, is projected to grow significantly, driven by increasing patient populations and new product launches.
• Regional Dominance: North America, particularly the U.S., dominates the market due to high HIV prevalence and the presence of key players.
• Growth Drivers: Increasing patient populations, new product launches, and government awareness programs are key drivers of market growth.

FAQs

What are the common adverse reactions associated with SUSTIVA?

SUSTIVA is associated with central nervous system symptoms, including severe depression, suicidal ideation, non-fatal suicide attempts, aggressive behavior, paranoid reactions, and manic reactions[1][4].

How does SUSTIVA perform in long-term clinical trials?

Long-term data from clinical trials indicate that SUSTIVA-containing regimens are effective in maintaining viral suppression over extended periods, with the incidence of new-onset nervous system symptoms similar to control groups beyond 24 weeks[1].

What is the current market size and growth projection for HIV drugs?

The global HIV drugs market was valued at $34.13 billion in 2023 and is projected to grow to $58.24 billion by 2032, with a CAGR of 6.2% during the forecast period (2024-2032)[5].

Which region dominates the HIV drugs market?

North America, particularly the U.S., dominates the market due to the high prevalence of HIV infection and the presence of key players like ViiV Healthcare and Gilead Sciences Inc.[5].

What are the key drivers of the HIV drugs market growth?

The growth is driven by the increasing patient population, new product launches, and government awareness programs. The introduction of innovative treatments like the 2-drug regimen Dovato also contributes to market growth[3][5].

Sources

1. Pr SUSTIVA® - Bristol Myers Squibb. Retrieved from https://www.bms.com/assets/bms/ca/documents/productmonograph/SUSTIVA_EN_PM.pdf
2. Sustiva - Drug Insight, 2019 - ResearchAndMarkets.com. Retrieved from https://www.businesswire.com/news/home/20190313005355/en/Sustiva---Drug-Insight-2019---ResearchAndMarkets.com
3. ViiV Healthcare announces positive data demonstrating 2-drug regimen Dovato is as effective as 3-drug regimen Biktarvy for maintenance therapy of HIV-1. Retrieved from https://www.viivhealthcare.com/hiv-news-and-media/news/press-releases/2024/july/viiv-healthcare-announces-positive-data-demonstrating/
4. SUSTIVA (efavirenz) Label - accessdata.fda.gov. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020972s049-021360s038lbl.pdf
5. HIV Drugs Market Size & Growth | Global Report [2024-2032]. Retrieved from https://www.fortunebusinessinsights.com/industry-reports/hiv-aids-drugs-market-101115

Last updated: 2025-01-01