Status:
COMPLETED
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
Lead Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Collaborating Sponsors:
Tibotec Pharmaceutical Limited
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 ...
Detailed Description
The chronicity of the disease which will require treatment over decades, long-term adverse events associated with standard combined antiretroviral therapy, emphasize the need for simpler, alternative ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT00421551
Start Date
March 1 2007
End Date
February 1 2011
Last Update
July 18 2013
Active Locations (1)
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1
Service des maladies infectieuses et tropicales Hopital Pitie salpetriere
Paris, France, 75013