Recruiting
Phase 2
Doravirine/Lamivudine (DOR/3TC) as a Maintenance ART in Comparison With Dolutegravir/Lamivudine (DTG/3TC) in PLWH Successfully
Condition(s) studied
HIV-1-infection
Investigational drug(s) / intervention(s)
Doravirine 100Mg Tab and Lamivudine 300 Mg TabDolutegravir 50mg Tab and Lamivudine 300 Mg Tab
Doravirine 100Mg Tab and Lamivudine 300 Mg Tab: 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
Dolutegravir 50mg Tab and Lamivudine 300 Mg Tab: Participants randomised in the "arm 2" will receive the DTG/3TC combination: dolutegravir 50 mg/lamivudine 300 mg (DOVATO®) 1 pill a day
Study 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).
Eligibility
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;
* 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,
* OR, in case of no available HIV-RNA genotype, genotype on proviral HIV-DNA to performed before inclusion,
* 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,
* 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)
Primary outcome measure(s)
- Measure the virological efficacy at week 48 to assess the effectiveness of the dual therapy to maintain the virological success to week 48 — Week 48
Measure ol plasma viral load assessed by RNA quantification using COBA 6800 system (Roch)
Trial sites (1)
| Facility | City | Region | Status |
|---|
| Hôpital Pitié-Salpêtrière |
Paris |
Île-de-France Region |
Recruiting |
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