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Study Comparing Efficacy and Safety of Darunavir Boosted With Ritonavir to HART With 2 NRTI and Darunavir Boosted With Ritonavir in HIV-1 Infected Patients ANRS136

NCT00421551

CompletedPhase 3

Sponsor: French National Agency for Research on AIDS and Viral Hepatitis

Conditions: HIV Infections

Interventions: Darunavir, ritonavir

Countries: France

The purpose of this study is to evaluate whether a monotherapy of boosted darunavir is able to maintain the virological success until 48 weeks in comparison to a standard therapy 2 INTI + darunavir/r in HIV infected patients with full viral suppression.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Confirmed HIV-1 infection.
* Documented level of HIV-1 RNA at initiation of antiretroviral treatments
* Prior antiretroviral regimen, including at least 2 NRTIs combined to 1 PI or NNRTI or a third NRTI for at least 18 months prior to study entry.
* CD4 count of 200 cells per mm3 or greater.
* Viral load below 400 copies per ml within 18 months prior to entry and below 50 copies per mL at entry.
* Willing to use acceptable methods of contraception

Exclusion Criteria:

* Previous virological failure under prior PI-based regimen.
* Prior therapy in the darunavir.
* HIV-2 infected patients.
* Absence of documented level of HIV-1 RNA at initiation of antiretroviral treatments
* Hepatitis B or C infection within 90 days prior to study entry.
* Therapies including interferon, interleukin-2, cytotoxic chemotherapy or immunosuppressors at study entry.
* Serious acute illness requiring systemic treatment or hospitalization in the 14 days prior to study entry.
* Treatment for an active AIDS defining opportunistic infection within 30 days prior to screening
* Drug or alcohol use or any dependence that would interfere with compliance.
* Pregnancy or breastfeeding

Locations (1)

Paris, France