Comparing two HIV treatment regimens for maintaining viral suppression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial aims to compare the effectiveness of two antiretroviral therapy regimens, Doravirine/Lamivudine (DOR/3TC) and Dolutegravir/Lamivudine (DTG/3TC), in maintaining virological success in people living with HIV who have achieved viral suppression. Participants must have a stable three-drug regimen prior to inclusion and will be monitored for virological failure over a 48-week period. The study seeks to evaluate a dual therapy option that avoids integrase inhibitors and boosted protease inhibitors, addressing the needs of patients with specific treatment histories or comorbidities.

Why it matters

Who can join: the full rules

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)

Where it's running

• Hôpital Pitié-Salpêtrière
  Paris, Île-de-France Region, France Recruiting

Study contacts

• Principal investigator: Romain PALICH, MD — Pitié-Salpêtrière Hospital
• Study coordinator: Yasmine DUDOIT
• Email: yasmine.dudoit@aphp.fr
• Phone: +33 (0)142164181

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.