Dual combination therapy for HIV-1 infected patients

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 clinical trial evaluates the effectiveness of a dual combination therapy using doravirine and raltegravir in HIV-1 infected patients. The study focuses on patients who have achieved viral suppression and are on a stable antiretroviral regimen. By assessing the long-term safety and efficacy of this combination, the trial aims to address the cumulative toxicities associated with traditional antiretroviral therapies. Participants will be monitored for their HIV-RNA levels and overall health outcomes over the course of the trial.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 years
* Patients with HIV-1 documented infection
* CD4 ≥ 200/mm3
* On stable combined ART regimen with at least 2 drugs for at least 6 months
* HIV-RNA plasma VL ≤ 50 copies/mL during the last 12 months prior to screening visit (W-6/W-4), documented by at least 2 time-points with no more than one blip (defined as one HIV-RNA plasma VL between 51 and 200 copies/mL followed by one HIV-RNA plasma VL ≤ 50 copies/mL)
* Naive to doravirine
* Absence of resistance to doravirine\* and/or raltegravir\*\*(see list mutations below)

  * on all HIV-genotypes with available RT and integrase gene sequences allowing resistance interpretation in case of previous virological failure
  * or on DNA genotype performed at screening if HIV genotype is not available in case of prior virological failure.
* Signed informed consent form.
* Patient affiliated to a social insurance regimen. For French patients only: subject enrolled in or a beneficiary of a Social Security programme (State Medical Aid or AME is not a Social Security programme).

  * Mutations associated to doravirine resistance are: V106A/M, Y188L, G190E/S, M230L, F227C, at least 2 among: A98G, L100I, K101E, V106I, E138K, Y181C/V, G190A or H221Y

    * Mutations associated to raltegravir resistance are: T66A/K, E92Q, G118R, F121Y, G140A/S Y143A/C/G/H/R/S, Q148E/G/H/K/R, V151L, N155H/S/T, E157Q, S230R, R263K, L74 F/I + V75I.

Exclusion Criteria:

* Absence of RT and INI HIV sequence available (past genotypes or failure of amplification of DNA at screening)
* HBV co-infection
* Hemoglobin \<9 g/dL
* Platelets \<80,000/mm3
* Creatinine clearance \<60 mL/min (MDRD)
* AST or ALT ≥5N
* Concomitant DAA for anti-HCV therapy
* Any severe concomitant illness
* Any drug with potential drug-drug interaction with doravirine
* Concomitant treatment using interferon, interleukins or any other immune-therapy or chemotherapy
* Concomitant prophylactic or curative treatment for an opportunistic infection
* All conditions (use of alcohol, drugs, etc.) judged by the investigator to possibly interfere with trial protocol compliance, adherence and/or trial treatment tolerance
* Subjects under "sauvegarde de justice" (judicial protection due to temporarily and slightly diminished mental or physical faculties), or under legal guardianship
* Subjects participating in another clinical trial evaluating different therapies and including an exclusion period that is still in force during the screening phase
* Pregnant women or breastfeeding women

Where it's running

• Christine KATLAMA
  Paris, Île-de-France Region, France Recruiting

Study contacts

• Principal investigator: Christine Katlama, MD — Pitie-Salpetriere Hospital
• Study coordinator: Yasmine Dudoit
• Email: yasmine.dudoit@aphp.fr
• Phone: 33142164181

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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.