Each subject must be ? 18 years of age with a diagnosis of HIV Infections
Conditions
Interventions
Trade Name: ISENTRESS ®
Product Name: ISENTRESS
Product Code: MK0518
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: RALTEG
Sponsors
MSD Italia s.r.l
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Each subject must be ? 18 years of age. 2. Each subject must be male or non-pregnant, non-breastfeeding female 3. Each subject must have diagnosis of HIV infection. 4. Each subject must have no history of previous virological failure (defined as 2 consecutive plasma HIV-1 RNA >200 copies/mL while on previous or current ARV therapy) 5. Each subject must have no history of previous exposure to NNRTIs or INIs prior to entering the study 6. Each subject must have no history of previous intolerance to Lamivudine 7. Each subject must have at least 2 documented plasma HIV-1 RNA 50 copies/mL in the 12 months prior to the screening visit 8. Each subject must be taking the same PI/r + TDF/FTC based ARV combination for at least 6 months before screening 9. Each subject mustn't have major IAS-USA mutations on genotypic testing performed before starting ARV treatment. 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 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: 1.The subject has HBsAg+ or anticipated need for HCV-treatment 2. The subject has grade 2-4 laboratory abnormality of liver transaminases (ALT and AST) 3. The subject has experiencing liver cirrhosis 4. The subject has an allergy/sensitivity to investigational product or its/their excipients. 5. The female subject is nursing. 6. The female subject is pregnant or intending to become pregnant. 7. The subject has any clinically significant condition or situation, other than the condition being studied that, in the opinion of the investigator, would interfere with the trial evaluations or optimal participation in the trial. 8. The subject has active AIDS-defining event (CDC-C), exception for stable Kaposi Sarcoma, HIV Wasting Syndrome.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: The detection time is between baseline and week 48;Primary end point(s): The primary end-point will be the change from BL in eGFR (MDRD) at Week 48.; Main Objective: To assess the changes in renal function (e.g. estimated GFR measured by MDRD formula with 6 variables that is MDRD 4 variables plus blood urea nitrogen and albumin) and the frequency of experiencing a decline of renal function in HIV-infected patients with an eGFR (MDRD-6 variables) < 60 mL/ min/1.73 m2 at 48 weeks of follow up. ; Secondary Objective: To evaluate changes in eGDR-MDRD during 96 weeks of follow up. To assess the efficacy (stable suppressed HIV-RNA <50c/ml) after switch from PI/r (LPV/r, ATV/r, DAR/r)+TDF/FTC to RAL + NVP + 3TC in patients with a stable HIV-1 RNA < 50 copies/mL in the previous 12months during 48 and 96 weeks. To assess laboratory alterations (liver enzymes, lipid profile) after switch from PI/r (LPV/r, ATV/r, DAR/r) + TDF/FTC to RAL + NVP + 3TC in patients with a stable HIV-1 RNA < 50 copies/mL in the previous 12 months during 48 and 96 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The Main Secondary Efficacy End-point will be the proportion of subjects with HIV-RNA < 50 cp/ml at 48 weeks according to intent-to-treat (ITT) analysis.;Timepoint(s) of evaluation of this end point: The detection time is between baseline and week 48 | — |
Countries
Italy
Contacts
Public ContactDivisione Ricerca Clinica
MSD Italia s.r.l
Outcome results
None listed