A randomized comparative phase II trial evaluating the capacity of the dual combination doravirine/raltegravir to maintain virological success in HIV-1 infected patients with an HIV-RNA plasma viremia below 50 copies/mL under a current antiretroviral regime

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 150

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials