Status:
COMPLETED
Clinical Study to Evaluate the Efficacy and Safety of Lopinavir/Ritonavir Monotherapy Versus Darunavir/Ritonavir Monotherapies as Simplification Switching Strategies of PI/NNRTI-Triple Therapy Based-Regimens
Lead Sponsor:
Germans Trias i Pujol Hospital
Conditions:
HIV Infections
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine the non-inferiority in the efficacy of DRV/r (900/100 mg) monotherapy at 48 weeks versus LPV/r (400/100 mg) as simplification strategy in subjects with sustai...
Detailed Description
The pillar of the current standard of care for highly active antiretroviral therapies (HAART) is the use of two nucleoside reverse transcriptase inhibitors (NRTIs).1 However, these agents can inhibit ...
Eligibility Criteria
Inclusion
- HIV-1 infected adults (=/+18 years old).
- Patients having a diagnosis of HIV infection, on stable HAART including:
- 2 NRTI/NtRTIs plus one of the following : 1 PI/ritonavir (lopinavir/ritonavir, atazanavir/ritonavir, fosamprenavir /ritonavir, tipranavir/ritonavir, darunavir/ritonavir) or ATV/unboosted (in a regimen without tenofovir) 1 NNRTI (nevirapine or efavirenz), raltegravir or maraviroc
- Undetectable plasma HIV-1 RNA (VL \< 50 copies/mL) while on HAART during at least 3 month prior to switching.
- Nadir CD4 cell count \> 100 cells/mm3.
- Absence of major PI-resistance mutations in HIV-protease (IAS 2008).20 Good treatment adherence.
- Voluntary written informed consent.
- Patients and physician's preference to change the current HAART regimen for reasons of simplification and/or toxicity.
Exclusion
- History of virological failure to a previous antiretroviral protease-containing regimens.
- History of virological failure defined as two consecutive plasma HIV-1 RNA \> 50 copies/mL while on current antiretroviral therapy
- Acute infections or uncontrolled chronic infection in the 2 months previous to the inclusion or physical examination that, in the investigator's opinion, would compromise the patient's safety or outcome of the study
- Breastfeeding, pregnancy or fertile women willing to be pregnant.
- Patients co-infected with hepatitis B.
- Concomitant use of any drug with potential drug-drug interaction with DRV/r or LPV/r at study entry.
- Therapies including interferon, interleukin-2, cytotoxic chemotherapy or immunosuppressors at study entry.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT00994344
Start Date
October 1 2009
End Date
October 1 2012
Last Update
February 13 2014
Active Locations (2)
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1
Germans Trias i Pujol Hospital
Badalona, Barcelona, Spain, 08916
2
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Canary Islands, Spain, 38320