MODULO

Phase 3

Recruiting

Conditions: HIV

Registration Number: 2024-515793-27-01

Lead Sponsor: Centre De Recherches Et D'Etudes Sur La Pathologie Tropicale Et Le Sida, ANRS Maladies Infectieuses Emergentes

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 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).

Detailed Description: Not available

Recruitment & Eligibility

Status: Ongoing, recruiting

Sex: Not specified

Target Recruitment: 408

Inclusion Criteria

• 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.

Exclusion Criteria

• 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, using the last version of the ANRS-MIE algorithm;

• At least one resistance genotype is mandatory to include the patient: o If there was no virological failure under NRTI, NNRTI and INSTI in the past: - Pretherapeutic HIV-RNA genotype, - OR, in case of no available HIV-RNA genotype, genotype on proviral HIV-DNA to performed before inclusion, o In case of virological failure under NRTI, NNRTI and INSTI in the past: - HIV-RNA genotype at time of virological failure, - OR, in case of no available HIV-RNA genotype at time of failure, genotype on proviral HIV-DNA to performed before inclusion to be sure that the virus is fully sensitive to the study treatments, o Past virological failure is defined as: 2 consecutive pVL ≥50 copies/mL or one pVL ≥200 copies/mL, o 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 contraception;

• Any clinal condition limiting the participation in a clinical trial.

Study & Design

Study Type: Not specified

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of participants with virological failure at W48 (2 consecutive pVL >50 copies/mL with a delay of 2-4 weeks).		Proportion of participants with virological failure at W48 (2 consecutive pVL >50 copies/mL with a delay of 2-4 weeks).

Secondary Outcome Measures

Name	Time	Method
Proportion of participants with discontinuation of treatment or follow-up over 96 weeks;		Proportion of participants with discontinuation of treatment or follow-up over 96 weeks;
Proportion of participants with virological failure at W96;		Proportion of participants with virological failure at W96;
Proportion of participants with new resistance associated mutations in case of virological failure;		Proportion of participants with new resistance associated mutations in case of virological failure;
Plasma drug concentrations at W24, W48, W72 and W96, and in case of virological failure;		Plasma drug concentrations at W24, W48, W72 and W96, and in case of virological failure;
Proportion of participants with severe biological or clinical side effect over 96 weeks;		Proportion of participants with severe biological or clinical side effect over 96 weeks;
CD4 and CD8 T-cell counts, CD4/CD8 ratio at D0, W48 and W96;		CD4 and CD8 T-cell counts, CD4/CD8 ratio at D0, W48 and W96;
Body weight and BMI et IMC at D0, W48 and W96;		Body weight and BMI et IMC at D0, W48 and W96;
Metabolic biomarkers (total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides and glycemia) at D0, W48 and W96;		Metabolic biomarkers (total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides and glycemia) at D0, W48 and W96;
Levels of total HIV-DNA in PBMC at D0, W48 and W96;		Levels of total HIV-DNA in PBMC at D0, W48 and W96;
Proportion of participants with residual viremia at D0, W48 and W96;		Proportion of participants with residual viremia at D0, W48 and W96;
Levels of satisfaction associated with study treatments at D0, W48 and W96 (HIVTSQ questionnaire);		Levels of satisfaction associated with study treatments at D0, W48 and W96 (HIVTSQ questionnaire);
Drug concentrations in female genital secretion or semen at W24 and W48 (among participants of the “genital compartment” sub-study);		Drug concentrations in female genital secretion or semen at W24 and W48 (among participants of the “genital compartment” sub-study);
Levels of HIV-RNA in female genital secretion or semen at W24 and W48 (among participants of the “genital compartment” sub-study).		Levels of HIV-RNA in female genital secretion or semen at W24 and W48 (among participants of the “genital compartment” sub-study).

Trial Locations

Locations (31): Centre Hospitalier Regional De Marseille
🇫🇷
Marseille, France
Centre Hospitalier Universitaire de Clermont-Ferrand - Hôpital Gabriel Montpied
🇫🇷
Clermont-Ferrand Cedex 1, France
Hopitaux Universitaires Pitie Salpetriere
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Paris Cedex 13, France
Centre Hospitalier Universitaire De Toulouse
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Toulouse, France
Centre Hospitalier Universitaire De Bordeaux
🇫🇷
Bordeaux, France
Hôpital Raymond-Poincaré
🇫🇷
GARCHES, France
Hopital Tenon
🇫🇷
Paris Cedex 20, France
Hopital Necker Enfants Malades
🇫🇷
Paris, France
Centre Hospitalier Universitaire Hôtel-Dieu
🇫🇷
Paris, France
Centre Hospitalier Universitaire De Saint Etienne
🇫🇷
Saint Priest En Jarez, France
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Centre Hospitalier Regional De Marseille
🇫🇷Marseille, France
Olivia ZAEGEL-FAUCHER
Site contact
+33491744966
olivia.zaegel@ap-hm.fr
Amélie MENARD
Site contact
+33662197411
amelie.menard@ap-hm.fr