PT HIV-1 positive and naive to antiretroviral drug MedDRA version: 9.1 Level: LLT Classification code 10020161 Term: HIV infection
Conditions
Interventions
Trade Name: SUSTIVA
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Efavirenz
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 600-
Trade Name: KALETRA
Sponsors
AZIENDA OSPEDALIERA POLICLINICO DI MODENA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 18 years HIV-1 infection Negative Pregnancy Test No primary mutation of the three study drugs Naive to antiretroviral therapy symptomatic HIV-1 Infection asymptomatic HIV-1 Infection with CD4 350 asymptomatic HIV-1 Infection with CD4 350 and VL 100000 c/mL 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: AIDS dementia MDRD 60 mL/min or nephropathy Inability to comprehend the informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate toxicity and adherence of three antiretroviral regimen including NNRTI EFV or PI LPV/r or their stucures rotation.;Secondary Objective: Evaluate viroimmunologic efficacy of three antiretroviral regimen and the development of viral mutation;Primary end point(s): L obiettivo principale dello studio e confrontare nella popolazione naive alla terapia antiretrovirale, tre regimi di terapia antiretrovirale di associazione comprendenti NNRTI EFV , PI LPV/r o loro rotazione strutturata, analizzando il loro impatto sulla tossicita farmacologia e l aderenza, valutate con questionari autocompilativi di monitoraggio dei sintomi e dell aderenza e con rilevazione plasmatiche dei parametri bioumorali delle concentrazioni farmacologiche. | — |
Countries
Italy
Outcome results
None listed