Efficacy and Safety of Doravirine in the Rapid Initiation

NCT07357584 | Not Yet Recruiting Phase 4

• 1 other identifier: FH-96
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

Protocol title: "Efficacy and safety of doravirine in the rapid initiation of highly active antiretroviral therapy (HAART) in HIV-1positive patients without prior treatment."

Conditions

HIV-1-infection

Keywords

Efficacy; Safety; Doravirine; Rapid initiation of highly active antiretroviral therapy

Outcome Measures

Primary Outcomes (1)

• Evaluate the antiviral activity of DOR/3TC/TDF at week 48 in HIV patients without prior antiretroviral treatment, in a rapid initiation setting.

  Proportion of patients with a viral load \< 50 copies/mL at week 48, as determined by an intention-to-treat analysis (FDA snapshot analysis) of the exposed population (ITT-E)

  48 Weeks

Secondary Outcomes (10)

• Evaluate the antiviral activity of DOR/3TC/TDF at < 200 copies/mL at week 48, using the intention-to-treat analysis (FDA snapshot analysis) for the exposed population (ITT-E).

  48 Weeks

• Evaluate the antiviral activity of DOR/3TC/TDF at week 48 using an observed analysis (only including patients with available virological data).

  48 Weeks

• Evaluate the antiviral activity of DOR/3TC/TDF in the subgroup of participants with baseline ITINN mutations that do not confer resistance to doravirine, by calculating the proportion of patients with viral load <200 c/mL and <50 c/mL at week 48.

  48 Weeks

• Evaluate the antiviral activity of DOR/3TC/TDF at <200 copies/mL and <50 copies/mL at week 24.

  24 Weeks

• Evaluate the safety and tolerability of DOR/3TC/TDF.

  52 Weeks

Study Arms (1)

Doravirine /Lamivudine/ Tenofovir Disoproxil

EXPERIMENTAL

Doravirine 100 mg/Lamivudine 300 mg/Tenofovir disoproxilo245 mg

Drug: Doravirine / lamivudine/ Tenofovir Disoproxil Oral Tablet

Interventions

Doravirine / lamivudine/ Tenofovir Disoproxil Oral Tablet DRUG

Pharmaceutical form: Oral tablets Unit dose concentration/dose level(s): 100/300/245 mg Administration instructions: Take one tablet once a day

Also known as: Delstrigo

Doravirine /Lamivudine/ Tenofovir Disoproxil

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has to voluntarily signed and dated an informed consent form, approved by an institutional ethics committee.
• ≥18 years of age.
• Not previously exposed to ARV (naïve). Subject may have received oral PrEP and PEP within the last 6 months and injectable PrEP and PEP within the last year.
• Have a received an HIV diagnosis within 30 days prior to selection. Defined as: Having confirmed HIV-1 infection. HIV-1 positive result is considered if the HIV1 RNA in plasma is ≥ 1000 copies/mL or two HIV antibody tests (using two different tests) are positive.
• NOTE: Participants may be included without knowing their baseline viral load. If baseline viral load results are less than 1000 copies/mL, the volunteer's participation will be suspended and they will be considered to have failed the screening test. A viral load brought by the subject may be considered if it was performed within the last 30 days prior to the SCR visit.
• CD4+ T-cell count: No limit.
• Subjects able to meet the protocol requirements.

You may not qualify if:

• History of hypersensitivity to doravirine, tenofovir, or lamivudine.
• Severe hepatic impairment (Child-Pugh C).
• Active HCV infection requiring specific treatment during study participation at the time of eligibility assessment. If HCV is diagnosed during the study and the participant requires treatment, the decision on whether to continue in the study will be at the investigator's discretion.
• A woman may be eligible to enter and participate in the study if she is not pregnant (confirmed by a negative urine pregnancy test at the time of screening/baseline). If the baseline visit is scheduled on a different day than the SCR, the urine pregnancy test will be repeated) or breastfeeding and if at least one of the following conditions applies:
• Women without reproductive capacity, defined as premenopausal women with tubal ligation or hysterectomy, or documented bilateral oophorectomy; or as postmenopausal women with 12 months of spontaneous amenorrhea, and women ≥ 45 years of age without hormone replacement therapy.
• Women with reproductive capacity who agree to adopt one of the contraceptive options in Appendix 2 for at least 30 days after the last dose of study medication and/or completion of the follow-up visit.
• The chosen contraceptive method must be used consistently, according to the approved product label. All study participants must be advised on safer sex practices, including the use of effective barrier methods, and the choice of effective contraceptive method must be documented in the eCRF (Electronic Case Report Form).
• The subject's general health status, in the investigator's oIPnion, interferes with the requirements of the study.
• Has a diagnosis of an active opportunistic infection defining AIDS or a malignant neoplasm within 30 days prior to evaluation (except Kaposi's sarcoma with fewer than 10 skin lesions).
• Is participating or has participated in a clinical study in the last 6 months.
• Creatinine clearance (CrCl) ≤50 mL/min according to the Cockcroft-Gault equation.
• Any verified Grade 4 abnormality (except liIPds: HDL, LDL, total cholesterol, triglycerides).
• History or presence of allergy to study drugs or their components, or to drugs in their class.
• Subjects taking any medication during the study, including over-the-counter medications and herbal preparations, without the approval of the study physician.
• Mutations resistant to doravirine, 3TC, or TDF, according to the list described below:

Sponsors & Collaborators

• Fundación Huésped: lead
• MSD Pharmaceuticals LLC: collaborator
• Fundacion IDEAA: collaborator

Study Sites (2)

Fundacion IDEAA -Infectologia de atencion ambulatoria

Ciudad Autonoma de Buenos Aire, Buenos Aires, C1405CKC, Argentina

Location

Fundacion Huesped

Buenos Aires, C1202ABB, Argentina

Location

MeSH Terms

Interventions

doravirine; Lamivudine; Tenofovir

Intervention Hierarchy (Ancestors)

Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Pedro E Cahn, MD

CONTACT

1121209999; pedro.cahn@huesped.org.ar

María I Figueroa, MD

CONTACT

1121209999; maria.figueroa@huesped.org.ar

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Prospective, multicenter, non-randomized, single-arm, non-comparative, open-label study design

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: January 22, 2026
• Study Start (Estimated): July 13, 2026
• Primary Completion (Estimated): January 13, 2028
• Study Completion (Estimated): January 13, 2028
• Last Updated: January 22, 2026

Record last verified: 2026-01

Locations

AR (2)