Evaluation of a Dose Reduction of Darunavir (400 mg/d) in Virologically Suppressed HIV-1 Patients (NCT02384967) | Clinical Trial Compass
CompletedPhase 2
Evaluation of a Dose Reduction of Darunavir (400 mg/d) in Virologically Suppressed HIV-1 Patients
France100 participantsStarted 2015-03
Plain-language summary
Phase II trial assessing the efficacy of a reduced dose strategy of darunavir to 400 mg/d in HIV-1 infected patients virologically suppressed under a once daily regimen including darunavir 800 mg/d and two nucleoside reverse transcriptase inhibitors (NRTI), to maintain the viral load lower than 50 copies / mL at 48 weeks of treatment.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* HIV-1 infected adults,
* age ≥ 18 years,
* with a once-a-day ritonavir-boosted darunavir 800mg/j containing regimen plus 2 NRTI (≥ 6 months),
* virologically controlled (VL ≤ 50 cp/ml,
* ≥ 1 year,
* at least 2 VL spaced at least 3 months apart in the last 12 months) CD4 count ≥ 300/mm3 ≥ 6 months,
* virus sensible to darunavir and the used NRTI (pretreatment resistance genotypic test available) and
* with no history of virological failure (VL \> 200 cp/mL after ≥ 6 months under PI and/or used NRTI),
* no current opportunistic infection,
* renal clearance ≥ 60 mL/min if tenofovir is used,
* transaminases (SGOT, SGPT) plasma levels \< 2N,
* hemoglobin \> 11 g/dL,
* platelets count \> 150 000/mm3,
* negative pregnancy test in women with childbearing potential,
* informed written consent signed by both the investigator and the subject,
* national insurance scheme (article L1121-11 of the French Public Health code),
* no participation to any other clinical trial
Exclusion Criteria:
* HIV-2 infection,
* current antiretroviral therapy different from a once-a-day ritonavir-boosted darunavir 800mg/j containing regimen plus 2 NRTI,
* virus genotypically resistant to darunavir and the used NRTIs,
* history of virological failure (VL \> 200 cp/mL after ≥ 6 months under PI and/or used NRTI),
* irregular follow-up and/or history of lack of adherence to ART ≤ 12 months,
* current pregnancy,
* current opportunistic infection,
* associated treatment containing one or …
What they're measuring
1
Proportion of patients with therapeutic success, defined as no virological failure