💬In plain words
What the trial is, and whether it could suit you
The objective of antiretroviral therapy (ART) is the maintenance of HIV viral suppression, the optimal condition to prevent disease progression, to optimize immune restoration, to prevent the development of viral resistance and to reduce viral transmission. Antiretroviral therapy has to be maintained long life over decades in the absence of strategies for HIV cure. This is why the long-term cumulative toxicity of ARV drugs is a major issue. Indeed as a consequence of potent ART strategies, in 2011 over 88% of patients on ART in the French Hospital database (ANRS CO4 FHDH) achieved viral suppression with HIV-RNA plasma viral load \< 50 copies/mL and nearly 60% had CD4 \> 500/mm3. As a consequence of massive reduction of mortality and morbidity related to HIV, infected patients are aging with 40% of patients over 50 years of age in the ANRS CO4 FHDH.
The current standard-of-care for antir
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
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