Status:
COMPLETED
DRV/r + RPV QD: Efficacy and Toxicity Reduction
Lead Sponsor:
ASST Fatebenefratelli Sacco
Collaborating Sponsors:
Elisa Colella, M.D.
Valentina Di Cristo, M.D.
Conditions:
Human Immunodeficiency Virus
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Clinical approach to HIV infection treatment is based on the use of highly active antiretroviral therapies (HAART) and recent national and international guidelines for guiding HIV therapy recommend th...
Detailed Description
Pilot, phase III prospective, randomized, open-label, multicentric controlled study, which will offer a novel dual-therapy regimen including RPV 25mg + DRV 800mg/rtv 100mg QD to HIV+ subjects with sup...
Eligibility Criteria
Inclusion
- Adult HIV+ subjects (\>18 years old), giving and signing an informed consent;
- Any HAART treatment for at least 12 months;
- Current treatment with a PI/r-containing regimen initiated at least 6 months earlier;
- HIV-RNA \<50 cp/mL for at least 3 months, without viral blip due to virologic failure at any time;
- Any nadir CD4 lymphocytes;
- Current CD4 count \> 100 cell/uL;
- eGFRs \>60 mL/min/1.73 m2.
Exclusion
- Previous drug resistance genotypic test showing the presence of any RPV (RT: K101E/P, E138A/G/K/Q/R, V179L, Y181C/I/V, Y188L, H221Y, F227C, M230I/L) or DRV (protease: V11I, V32I, L33F, I47V, I50V, I54M/L, T74P, L76V, I84V, L89V) resistance associated mutation (RAM), according to the November 2011 IAS-USA list;
- Child-Pugh C or grade 3-4 AST or ALT values;
- Acute cardiovascular event within 6 months;
- AIDS event within 6 months;
- Current IVDU;
- HBsAg +;
- Pregnancy or lactation.
Key Trial Info
Start Date :
September 30 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2018
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT01792570
Start Date
September 30 2014
End Date
December 31 2018
Last Update
April 2 2020
Active Locations (12)
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1
Clinica delle Malattie Infettive, Policlinico Universitario
Bari, BA, Italy
2
Divisione di Malattie Infettive, Ospedale S. Maria Annunziata, Antella
Florence, FI, Italy
3
Clinica delle Malattie Infettive, Ospedale San Martino, Università degli Studi
Genova, GE, Italy
4
Divisione di Malattie Infettive, Ospedale San Gerardo
Monza, MB, Italy