Status:
RECRUITING
HIV-1 Infected Patients, Phase II Trial, Dual Combination Doravirine/Raltegravir Open Label
Lead Sponsor:
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 developm...
Detailed Description
The recent years have highlighted the cumulative toxicities of long-term exposure to antiretroviral drugs. Cardiovascular disease is one of the most common comorbidities in the aging HIV-infected popu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04513626
Start Date
September 15 2020
End Date
October 30 2025
Last Update
January 10 2025
Active Locations (1)
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1
Christine KATLAMA
Paris, Île-de-France Region, France, 75013