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Evaluation of a Dose Reduction of Darunavir (400 mg/d) in Virologically Suppressed HIV-1 Patients

CompletedPhase 2

Sponsor: ANRS, Emerging Infectious Diseases

Conditions: HIV INFECTION

Interventions: Darunavir

Countries: France

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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 more drugs interacting with hepatic cytochromes,
* any addictive behaviors (alcohol consumption, drugs …) likely to jeopardize the safety of the treatment and / or patient compliance and adherence to the trial.

Locations (1)

Paris, France