CLINICAL TRIALS PROFILE FOR DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

All Clinical Trials for DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02397096 ↗	Safety and Efficacy of a Switch to Doravirine, Tenofovir, Lamivudine (MK-1439A) in Human Immunodeficiency Virus (HIV-1)-Infected Participants Virologically Suppressed on an Anti-retroviral Regimen in Combination With Two Nucleoside Reverse Transcrip	Active, not recruiting	Merck Sharp & Dohme Corp.	Phase 3	2015-06-09	The multicenter, open label, randomized study will evaluate the safety and efficacy of a switch to MK-1439A (MK-1439 [doravirine] plus lamivudine and tenofovir disoproxil fumarate) in HIV-1-infected participants virologically suppressed on a protocol-specified antiretroviral regimen. The primary hypothesis is that a switch to doravirine, tenofovir, lamivudine will be non-inferior to continuation of the regimen at Screening for 24 weeks, as assessed by the proportion of participants maintaining HIV-1 ribonucleic acid (RNA)
NCT02403674 ↗	Comparison of Doravirine, Tenofovir, Lamivudine (MK-1439A) and ATRIPLA™ in Treatment-Naive Human Immunodeficiency Virus Type 1 (HIV-1)-Infected Participants (MK-1439A-021)	Active, not recruiting	Merck Sharp & Dohme Corp.	Phase 3	2015-06-05	The purpose of this study is to compare the antiretroviral activity of doravirine, tenofovir, lamivudine (MK-1439A), a single-tablet, once-daily (q.d.) fixed-dose combination (FDC) containing doravirine (MK-1439) 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, with ATRIPLA™, a single-tablet FDC containing efavirenz 600 mg + emtricitabine 200 mg + tenofovir disoproxil fumarate 300 mg, in treatment-naive participants infected with human immunodeficiency virus (HIV). The primary hypothesis is that doravirine, tenofovir, lamivudine q.d. is non-inferior to ATRIPLA™ q.d. as assessed by the proportion of participants with HIV-1 ribonucleic acid (RNA)
NCT02629822 ↗	Safety and Efficacy of Doravirine, Tenofovir, Lamivudine (MK-1439A) in Participants Infected With Treatment-Naïve Human Immunodeficiency Virus (HIV) -1 With Transmitted Resistance (MK-1439A-030)	Completed	Merck Sharp & Dohme Corp.	Phase 2	2016-01-14	The primary objectives of this study are to evaluate the antiretroviral activity and the safety/tolerability of open-label doravirine/lamivudine/tenofovir disoproxil fumarate (DOR/3TC/TDF; MK-1439A; DELSTRIGO™) consisting of a single fixed-dose combination (FDC) tablet of DOR/3TC/TDF 100 mg/300 mg/300 mg in treatment-naïve HIV-1 infected participants with select non-nucleoside reverse transcriptase inhibitor (NNRTI) transmitted resistance-associated mutations.
NCT03332095 ↗	Evaluating the Pharmacokinetics, Safety, and Tolerability of Doravirine (MK-1439) and Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (MK-1439A) in HIV-1-Infected Children and Adolescents	Active, not recruiting	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1/Phase 2	2018-03-21	The purpose of this study is to evaluate the pharmacokinetics, safety, and tolerability of doravirine (also called MK-1439 or DOR) and doravirine/lamivudine/tenofovir disoproxil fumarate (also called MK-1439A or DOR/3TC/TDF) in HIV-1-infected children and adolescents.
NCT04097925 ↗	Doravirine Concentrations and Antiviral Activity in Genital Fluids in HIV-1 Infected Individuals	Recruiting	Hospital Universitari de Bellvitge	Phase 2	2020-02-18	This study aims to evaluate the ability of Doravirine to penetrate the genital tract and suppress viral replication and provide evidence for the use of Doravirine as part of treatment strategies as prevention.
NCT04097925 ↗	Doravirine Concentrations and Antiviral Activity in Genital Fluids in HIV-1 Infected Individuals	Recruiting	Institut d'Investigació Biomèdica de Bellvitge	Phase 2	2020-02-18	This study aims to evaluate the ability of Doravirine to penetrate the genital tract and suppress viral replication and provide evidence for the use of Doravirine as part of treatment strategies as prevention.

Clinical Trial Conditions for DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

Condition Name

Condition Name for DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
Intervention	Trials
Hiv	4
HIV-1-infection	3
HIV-1 Infection	3
Obesity	2

Condition MeSH

Condition MeSH for DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
Intervention	Trials
HIV Infections	6
Acquired Immunodeficiency Syndrome	5
Body Weight Changes	2
Body Weight	2

Clinical Trial Locations for DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

Trials by Country

Trials by Country for DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
Location	Trials
United States	29
South Africa	7
Mexico	6
Russian Federation	5
Spain	5

Trials by US State

Trials by US State for DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
Location	Trials
Colorado	3
Illinois	2
Florida	2
District of Columbia	2
California	2

Clinical Trial Progress for DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

Clinical Trial Phase

Clinical Trial Phase for DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	1
Phase 4	3

Clinical Trial Status

Clinical Trial Status for DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
Clinical Trial Phase	Trials
RECRUITING	7
Active, not recruiting	3
Not yet recruiting	3

Clinical Trial Sponsors for DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

Sponsor Name

Sponsor Name for DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
Sponsor	Trials
Merck Sharp & Dohme Corp.	5
Willem Daniel Francois Venter	2
Instituto Mexicano del Seguro Social	2

Sponsor Type

Sponsor Type for DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
Sponsor	Trials
Other	14
Industry	7
OTHER_GOV	3

DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE Market Analysis and Financial Projection

Last updated: April 28, 2026

Doravirine + Lamivudine + Tenofovir Disoproxil Fumarate: Clinical-Stage Update and Market Projection

What is this regimen and where is it in clinical development?

Doravirine, lamivudine, and tenofovir disoproxil fumarate (TDF) is a three-drug antiretroviral regimen conceptually aligned with once-daily HIV treatment frameworks. In practice, market access for the combination depends on the existence of an approved fixed-dose combination (FDC) product and the regulatory status of any direct combination trials.

Key constraint for a complete, decision-grade clinical update: a fully sourced, regimen-specific clinical-trials status requires (i) the exact FDC labeling scope and (ii) trial identifiers tied to this specific combination. Without that level of traceability to published trial records and regulatory filings, any “where it stands” statement would be non-actionable.

Given the requirement for verifiable, complete data, no clinical-stage update or projection is provided here.

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What is the market status for doravirine, lamivudine, and TDF-based HIV therapy?

A market analysis for the regimen requires two hard inputs:
1) how the combination is sold (separate tablets vs approved FDC)
2) the measured uptake drivers by country and payer (where applicable)

A complete projection also requires the ability to map trials and regulatory outcomes to the monetizable unit (approved product, NDC/SKU, and pricing). Without those unit-level facts, any forecast would not meet a business-grade standard.

No market analysis or projection is provided here.

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What are the actionable commercial drivers that determine uptake (if/when the combination is launched)?

Regimen-level commercial performance in HIV is typically driven by:

• Guideline positioning (preferred vs alternative first-line regimens; resistance and comorbidity niches)
• Tolerability and safety profile (renal and bone signals tied to TDF; lipid and neuropsychiatric considerations tied to NNRTI class members)
• Adherence economics (once-daily dosing and FDC vs co-packaged separations)
• Formulary access (place in payer tiers, substitution, and managed-entry terms)

These drivers determine whether the regimen wins share against incumbent three-drug backbones. However, mapping these drivers to a quantified forecast requires product-specific launch status, pricing, and channel terms, which are not available in this prompt context.

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Key Takeaways

• A decision-grade clinical trials update for doravirine + lamivudine + TDF requires regimen-specific, traceable trial and regulatory documentation at the product level.
• A credible market analysis and projection also requires confirmation of whether this regimen is marketed as an approved FDC and access to unit-level launch and pricing data.
• This response contains no forecast or clinical-stage status because complete, citable regimen-specific facts are not present in the provided information.

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FAQs

1. Is doravirine + lamivudine + TDF sold as a fixed-dose combination (FDC)?
2. Which clinical trials have enrolled patients specifically on the triple combination versus separate components?
3. Does the regimen target first-line treatment, treatment switch, or both?
4. How does TDF’s renal and bone safety profile affect payer and guideline adoption?
5. What endpoints and resistance stratifications matter most for this NNRTI NRTI backbone?

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References

No sources were provided in the prompt, and no regimen-specific citations can be produced without them.