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
Infections	9
Acquired Immunodeficiency Syndrome	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 Market Analysis and Financial Projection

Last updated: April 26, 2026

Sustiva (efavirenz): clinical trial status, market analysis, and projection

What is Sustiva and what is its current clinical posture?

Sustiva is the brand of efavirenz, an antiretroviral (ARV) in the non-nucleoside reverse transcriptase inhibitor (NNRTI) class. Efavirenz is an established component of HIV treatment regimens, particularly historically in first-line therapy where efavirenz-based fixed-dose combinations (FDCs) are available.

Clinical reality: Sustiva is not a “new drug” in active late-stage development; the clinical dataset is mature and the dominant activity in 2023 to 2026 is label maintenance, post-marketing surveillance, and incremental regimen positioning rather than new Phase 3 efficacy. Efavirenz and efavirenz-based regimens continue to be supported by long-standing guideline use in multiple geographies, with evolving regimen preferences for newer agents.

Core clinical anchors (public record):

• Efavirenz has long-term outcome evidence from pivotal Phase 3 programs leading to widespread adoption in combination therapy (standard of care historically for treatment-naïve patients).
• In contemporary practice, efavirenz-based regimens persist where cost, formulary access, and supply chain make them viable relative to newer integrase inhibitor (INSTI)-based options.
• Safety guidance remains anchored to well-characterized efavirenz risks including CNS effects and teratogenicity signals (regimen selection and pregnancy counseling remain practical differentiators in prescribing patterns).

What do major HIV regimen guidelines say about efavirenz today?

Guidelines have shifted toward integrase inhibitors for many populations, but efavirenz remains present as an option in multiple settings based on access and regimen construction. The following guideline positions are the most actionable for forecasting demand:

• WHO continues to recommend HIV regimens built around newer agents, with older NNRTI-based regimens used depending on availability, resistance patterns, and program constraints. WHO’s guidance has evolved over time away from NNRTI centrality, but efavirenz-based options remain in use where program architecture and commodity availability favor NNRTI continuity. (See WHO consolidated guidance.) [1]
• DHHS (US) has largely moved first-line recommendations toward INSTI-based regimens in treatment-naïve patients, but efavirenz can still appear in regimen discussions under circumstances where it remains appropriate and feasible. (See DHHS adult and adolescent ARV guidelines.) [2]

What clinical trial activity still matters for “Sustiva” demand?

The market impact of efavirenz is driven less by new endpoint-generation trials and more by:

• Guideline pathway placement (first-line vs alternative regimens).
• Resistance and switching behavior (how often efavirenz is used as a switch option or avoided due to baseline resistance or prior exposure).
• Fixed-dose combination availability (efavirenz used in FDCs changes procurement economics).
• Safety and pregnancy/psychiatric screening protocols (practical usage constraints in women of childbearing potential and CNS risk populations).

Public registries and scientific literature continue to show efavirenz’s role in:

• Comparative regimen studies versus other ARVs (often older comparators or real-world effectiveness cohorts).
• Pharmacokinetic and adherence studies for efavirenz-containing combinations.
• Pediatric or special population evaluations in historical windows rather than new first-line pivots.

Because your request is “clinical trials update,” the actionable takeaway is that efavirenz has mature clinical evidence and does not carry the same “trial-to-market” dynamics as a late-stage development pipeline product. The demand forecast therefore tracks policy and procurement more than it tracks new trial readouts.

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Market analysis for Sustiva: supply, access, and competitive positioning

Who buys efavirenz, and what are the dominant buyer segments?

Efavirenz demand historically comes from three procurement channels:

1. Government and donor-funded HIV programs (large-volume, tender-driven; NNRTI legacy usage remains relevant where budgets and supply contracts prefer established regimens).
2. Commercial payers in high-income markets (use is more variable as guidelines move to INSTI-led regimens).
3. Clinics and pharmacies in middle-income markets where formulary substitution depends on tender cycles and national guideline implementation timelines.

Efavirenz competes as a value brand primarily against:

• INSTI regimens (preferred in many guideline environments).
• Other NNRTIs used in FDCs (where national switches occur).

What drives pricing and margin structure for efavirenz?

Efavirenz is a mature molecule with generic competition, so pricing pressure and margin compression are expected. The market behaves like a commodity in many geographies:

• Tender pricing drives volume.
• Switching to newer regimens reduces unit demand over time even when efavirenz remains stocked as an alternative.
• Program stability can keep efavirenz utilization “sticky” for years via existing procurement contracts and clinical inertia.

What is the competitive landscape relative to INSTIs?

INSTIs have displaced NNRTIs in many guideline settings because of:

• Better tolerability profiles for many patients.
• Simpler dosing adherence and fewer CNS-related discontinuations.
• Strong resistance barrier performance in common regimen architectures.

That said, INSTI substitution is not instantaneous everywhere. Efavirenz continues to be used in settings where:

• INSTIs are not yet entrenched due to procurement cycles.
• Formularies prioritize cost containment.
• Clinicians still manage patients successfully on existing NNRTI regimens and avoid unnecessary switching.

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Market projection: 2026-2031 outlook

How should efavirenz demand trend over the next 5 years?

A realistic projection framework for efavirenz is a gradual volume decline in guideline-leading markets, offset partially by continued use in access-constrained settings and by legacy patient populations still controlled on NNRTI-based regimens.

Directional forecast:

• High-income markets: continued erosion of efavirenz share as INSTI regimens dominate first-line use and because alternative options are often available with better tolerability profiles.
• Low- and middle-income markets: slower decline, driven by national tender architecture and adherence to established NNRTI regimen frameworks until switches are executed at scale.

Demand components (what will change volume):

• Guideline adoption speed (policy-to-practice lag).
• Conversion of procurement from NNRTI to INSTI-led FDCs.
• Continued clinical use for patients already stable on efavirenz-based regimens.

Quantitative projection (scenario-based)

No single authoritative bottom-up forecast can be derived from the public record in a way that supports investment-grade precision without a specific dataset (e.g., IMS/IQVIA sales, WHO commodity volumes by product, tender-level pricing). Your request is for projections, but a numeric forecast requires a defined sales base and a sourcing dataset that is not provided here.

Actionable alternative: for decision-making, use a share-and-policy projection rather than unsupported unit numbers.

Projection structure for efavirenz/Sustiva (directional):

• 2026-2028: modest volume decline in INSTI-preferred geographies; stable-to-slow decline in access-constrained geographies.
• 2029-2031: acceleration of decline where national switches to INSTI-based regimens reach full scale; persistence in subpopulations and legacy cases where switching is deferred due to tolerability, adherence stability, or supply constraints.

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What matters for “Sustiva” specifically: brand vs molecule

Sustiva is a brand name; in many markets the competitive reality is dominated by generic efavirenz. Brand-level forecasts depend on:

• Whether the “Sustiva” brand is still materially stocked versus generics.
• Whether payer formularies still favor brand in specific regions.
• Whether a switching program changes what portion of efavirenz purchases remain labeled as “Sustiva” versus generics.

Market outcome therefore depends more on generic efavirenz procurement than on brand survival economics.

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Key Takeaways

• Efavirenz (Sustiva) is a mature NNRTI with clinical positioning shaped by guideline direction and procurement cycles, not new late-stage trial readouts.
• Current global HIV guidance has shifted toward INSTI-centered regimens, which drives gradual volume erosion in guideline-leading markets. Efavirenz remains used where access, formularies, and legacy patient stability keep NNRTIs in play. [1], [2]
• For 2026 to 2031, the most defensible forecast is directional decline, with the pace determined by national INSTI switch execution and continuation of controlled patients on NNRTI regimens rather than by a new clinical “event.”
• Brand-level projection for “Sustiva” is constrained by generic substitution; the market lens should treat “Sustiva” as the efavirenz exposure, not as a standalone brand growth story.

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FAQs

1) Is Sustiva still recommended in current HIV treatment guidelines?

Efavirenz-based regimens remain present in guideline frameworks, but dominant first-line recommendations have moved toward INSTI-based regimens in many settings, leaving efavirenz more as an option depending on patient factors and access. [1], [2]

2) What is driving efavirenz utilization in 2026?

Guideline pathway placement, tender and formulary access, and continued management of patients stable on NNRTI regimens. INSTI displacement is the main structural headwind. [1], [2]

3) Are there new pivotal clinical trials that will likely change efavirenz’s market position?

Efavirenz’s market position is not primarily driven by new pivotal trials. Activity is largely post-marketing, regimen comparisons across the mature landscape, and special population work rather than a trial that would reset standard-of-care adoption.

4) Does generic competition affect Sustiva’s market outlook?

Yes. In most markets, demand for efavirenz is dominated by generic versions, making “Sustiva” brand growth harder to sustain unless a specific payer or tender continues to label it.

5) What would accelerate efavirenz decline?

Faster national switching to INSTI-based FDC procurement and broader guideline implementation that reduces NNRTI-based first-line use at scale.

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References

[1] World Health Organization. (2023). Consolidated guidelines on HIV prevention, testing, treatment, service delivery and monitoring: Recommendations for a public health approach (8th ed.). WHO.
[2] Panel on Antiretroviral Guidelines for Adults and Adolescents. (2024). Guidelines for the use of antiretroviral agents in adults and adolescents with HIV. U.S. Department of Health and Human Services.