Doravirine/Lamivudine (DOR/3TC) as a Maintenance ART in Comparison With Dolutegravir/Lamivudine (DTG/3TC) in PLWH Successfully

NCT06774872 | Recruiting Phase 2 DMC

• 1 other identifier: CREPATS 19
• Study Type: interventional
• Target: 408
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of the MODULO trial is to compare (non-inferiority) the capacity of DOR/3TC and DTG/3TC two-drug regimens of maintain virological success at W48 in people living with HIV virus ( PLWH) with suppressed HIV plasma viral load (pVL) under three-drug regimen at inclusion. The virological success is defined as no virological failure (2 consecutive pVL ≥50 copies/mL or one pVL ≥50 copies/mL followed with discontinuation of treatment or follow-up).

Conditions

HIV-1-infection

Outcome Measures

Primary Outcomes (1)

• Measure the virological efficacy at week 48 to assess the effectiveness of the dual therapy to maintain the virological success to week 48

  Measure ol plasma viral load assessed by RNA quantification using COBA 6800 system (Roch)

  Week 48

Study Arms (2)

DORAVIRINE/LAMIVUDINE combination

EXPERIMENTAL

Patients randomized to "arm 1" will receive the DORAVIRINE/LAMIVUDINE combination: doravirin (PIFELTRO®) 100 mg 1 tablet per day + lamivudine (generic) 300 mg 1 tablet per day The dosage is in accordance with the summary of product characteristics of each product.

Drug: Doravirine 100Mg Tab and Lamivudine 300 Mg Tab

Fixed DOLUTEGRAVIR/LAMIVUDINE combination

ACTIVE COMPARATOR

Patients randomized to arm 2 will receive the fixed combination DOLUTEGRAVIR/LAMIVUDINE: dolutegravir 50 mg/lamivudine 300 mg (DOVATO®) 1 tablet per day. The dosage is in accordance with the summary of product characteristics of each product.

Drug: Dolutegravir 50mg Tab and Lamivudine 300 Mg Tab

Interventions

Doravirine 100Mg Tab and Lamivudine 300 Mg Tab DRUG

Participants randomised in the "arm 1" will receive the DORAVIRINE/LAMIVUDINE combination: doravirine (PIFELTRO®) 100 mg 1 pill a day + lamivudine 300 mg 1 pill a day

DORAVIRINE/LAMIVUDINE combination

Dolutegravir 50mg Tab and Lamivudine 300 Mg Tab DRUG

Participants randomised in the "arm 2" will receive the DTG/3TC combination: dolutegravir 50 mg/lamivudine 300 mg (DOVATO®) 1 pill a day

Fixed DOLUTEGRAVIR/LAMIVUDINE combination

Eligibility Criteria

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

You may qualify if:

• Adults ≥18 years;
• Living with HIV-1;
• With pVL \<50 copies/mL for at least 24 months;
• Under stable three-drug regimen including 2 NRTIs + 1 NNRTI or 1 INSTI or 1 boosted PI for at least 12 months;
• Affiliated to the French Social Insurance;
• Who have given their written consent to participate in the study

You may not qualify if:

• HIV-2 co-infection;
• Co-infection with hepatitis B virus (positive HBsAg and/or positive anti-HBc antibody with negative anti-HBs antibody);
• Documented resistance mutation or association of resistance mutations, associated with partial or full resistance to doravirine, dolutegravir or lamivudine;
• At least one resistance genotype is mandatory to include the patient:
• If there was no virological failure under NRTI, NNRTI and INSTI in the past:
• Pretherapeutic HIV-RNA genotype,
• In case of virological failure under NRTI, NNRTI and INSTI in the past:
• HIV-RNA genotype at time of virological failure,
• Past virological failure is defined as: 2 consecutive pVL ≥50 copies/mL or one pVL ≥200 copies/mL,
• Resistance genotypes will be interpretated with the last available ANRS algorithm.
• Glomerular filtration rate \<50 mL/min (CKD-EPI formula);
• Comedications leading to drug-drug interaction with one of the 3 study drugs (cf. detailed protocol);
• Pregnant or breastfeeding women, and women with age to be pregnant but refusing effective contraception, whether or not a desire for pregnancy is expressed;
• Any clinal condition limiting the participation in a clinical trial: Immunocompromised conditions including active cancer or hematological malignancy, organ transplant or with transplant rejection within the last 6 months, immunosuppressive therapy, or other condition that in the opinion of the investigator could cause impaired host immunity
• Protected adults (persons under legal guardianship or under "sauvegarde de justice" (judicial protection due to temporarily and slightly diminished mental or physical faculties)

Sponsors & Collaborators

• Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida: lead
• ANRS, Emerging Infectious Diseases: collaborator
• Organization providing support methodology coordination (Institut Pierre Louis d'Epidémiologie et de Santé Publique): collaborator

Study Sites (1)

Hôpital Pitié-Salpêtrière

Paris, Île-de-France Region, 75013, France

RECRUITING

MeSH Terms

Interventions

doravirine; Lamivudine; dolutegravir

Intervention Hierarchy (Ancestors)

Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides

Study Officials

• Romain PALICH, MD

  Pitié-Salpêtrière Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yasmine DUDOIT

CONTACT

+33 (0)142164181; yasmine.dudoit@aphp.fr

Romain PALICH, MD

CONTACT

+33 (0)142160171; romain.palich@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The MODULO trial is a prospective, multicentre, open-label trial, designed to asse the non-inferiority of DOR/3TC, in comparison with DTG/3TC, for maintaining the virological success in PLWH with suppressed viremia under three-drug regimens at inclusion. A follow-up over 96 week is expected. The 1:1 randomisation will be centralised and realised by the Methodology and Management Centre. The randomisation will be stratified according to the class of the third antiretroviral agent at time of screening (PI, NNRTI or INSTI), leading to three lists of randomisation.

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 14, 2025
• Study Start: April 30, 2025
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): June 15, 2028
• Last Updated: June 11, 2025

Record last verified: 2025-06

Locations

FR (1)