HIV-1 infection MedDRA version: 9 Level: LLT Classification code 10008919 Term: Chronic HIV infection
Conditions
Interventions
Trade Name: PREZISTA 300 mg comprimidos recubiertos
Pharmaceutical Form: Coated tablet
INN or Proposed INN: DARUNAVIR ETANOLATO
Other descriptive name: DARUNAVIR ETANOLATO
Concentration unit: mg milli
Sponsors
Fundació Lluita contra la SIDA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.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) or 1 NNRTI (nevirapine or efavirenz.) 2.Undetectable plasma HIV-1 RNA (VL 100 cells/mm3. 4.Absence of major PI-resistance mutations in HIV-protease (IAS 2008).20 5.Good treatment adherence. 6.Voluntary written informed consent. 7.Patients and physician's preference to change the current HAART regimen for reasons of simplification and/or toxicity. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.History of virological failure to a previous antiretroviral protease-containing regimens. 2.History of virological failure defined as two consecutive plasma HIV-1 RNA > 50 copies/mL while on current antiretroviral therapy 3.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 4.Pregnancy or fertile women willing to be pregnant. 5.Patients co-infected with hepatitis B. 6.Concomitant use of any drug with potential drug-drug interaction with DRV/r or LPV/r at study entry. 7.Therapies including interferon, interleukin-2, cytotoxic chemotherapy or immunosuppressors at study entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 sustained viral suppression on stable PI or NNRTI-antiretroviral regimens.;Primary end point(s): Plasmatic HIV-1 Viral load;Secondary Objective: -To compare CD4-cell count, liver enzymes, lipids, and resolution of toxicities at baseline and over 48 weeks of therapy in both treatment groups. -To evaluate the neurocognitive functioning in both groups, comparing global neurocognitive performance between study arms. -In a subgroup of voluntary patients: oTo compare the percentage of patients that mantained CSF-viral suppression (VL<50 copies/mL) at 48 weeks between treatment groups. oTo assess and compare the percentage of patients that allow genital tract and CSF-trough drug concentrations under MIC in both treatment groups. oTo evaluate the function of genital tract and CSF as HIV-1-reservoires, in case of virological failure, by means of phylogenetic and evolutionary analysis. oTo compare the percentage of patients that mantained viral suppression in genital tract (VL<50 copies/mL) at 24 and 48 weeks between treatment groups. | — |
Countries
Spain
Outcome results
None listed