HIV disease
Conditions
Interventions
Trade Name: Isentress
Product Name: Isentress
Product Code: 518048-05-0
Pharmaceutical Form: Tablet
INN or Proposed INN: Raltegravir
CAS Number: 518048-05-0
Other descriptive name: Isentress
Concentra
Sponsors
Rheinische Friedrich-Wilhelms-Universität Bonn
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - HIV and Hepatitis C co-infected patients - indication for HAART according to current German-Austrian guidelines - HAART naive - no primary NRTI / Integrase / PI associated resistance mutation according to the Stanford algorithm at screening; every patient MUST have a genotypic resistance assay prior baseline available (=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - advanced liver cirrhosis Child-Pugh B or C or decompensated liver disease - pegylated interferon / ribavirin or other anti-HCV therapy; planned anti-HCV therapy for duration of the study (48 weeks). - acute or chronic hepatitis B infection - acute hepatitis A or other hepatotropic virus infections - any other chronic liver disease such as alcohol abuse or hemosiderosis - use or planned use (for the duration of the study, 48 weeks) of rifampicin, St. John´s wort and drugs that are metabolizd via the cytochrome P450 system with a narrow therapeutic PK-range such as astemizole, terfenadine, cisapride, pimozide, chinidine, bepridile, triazolam, midazolam, ergotamine, dihydroergotamine, ergometrine, methyl-ergomethrine. FOR OTHER COMEDICATIONS please consult with the SPC of Raltegravir (Isentress®), Atazanavir (Reyataz®), Ritonavir (Norvir®), your hospital pharmacist, www.hiv-drug-interactions.org or the principal investigator in case of uncertainty. - new AIDS defining event, except for Kaposi sarcoma, < 1 months prior to screening - malignancy, except for Kaposi sarcoma, with current radio- or chemotherapy -history of organ transplantation - ALT = 5 fold the upper limit of norm - creatinine clearance < 70 ml / min according to Cockcroft-Gault - serum phosphate < 2.0 mg/dl - chronic kidney disease - diabetes mellitus - active use of illicit drugs - pregnancy, brest-feeding (not recommended for HIV-infected mothers because of risk of HIV transmission to the new-born) - any medical condition that in the view of the investigator is not suitable for participation in a clinical trial -participation in another clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: a. the number of grade 1/2 and 3/4 liver transaminase elevations at week 24 / 48 compared to baseline b. the number of grade 1/2 and 3/4 total bilirubin elevations at week 2 / 12 / 24 / 48 compared to baseline ;Secondary Objective: Secondary objectives: a. time to viral load < 50 copies/ml b. percent of patients achieving maximal suppression of HIV-RNA (< 50 copies/ml) at week 24 / 48 c. number of clinical adverse events related to hepatotoxicity at week 24 / 48 d. glucose sensitivity (HOMA index) at baseline, week 24 and 48 e. lipid abnormalities (total cholesterol, HDL, LDL, triglycerides) at baseline, week 24 and 48 f. number of gastrointestinal adverse events at week 24 / 48 g. number of any clinical or laboratory adverse events at week 24 / 48 h. patient satisfaction and adherence at Baseline and week 12 / 24 / 48 ;Primary end point(s): Primary objective: a. there is no difference in the rate of grade 1/2, or 3/4 ALT elevations b. there is a higher incidence of grade 1 – 4 hyperbilirubinemias in the ATV/r arm Secondary objectives: a. there is a faster time to viral load < 50 copies/ml in the RGV arm b. there is no difference in the rate of patients achieving maximal suppression of HIV-RNA at week 24 and 48 c. there is no difference in the rate of clinical adverse events related to hepatotoxicity d. there is no difference in the glucose sensitivity between ATV/r and RGV e. there is no difference in lipid abnormalities between ATV/r and RGV f. there is no difference in the number of gastrointestinal adverse events between ATV/r and RGV g. the number of any clinical or laboratory adverse event is lower in the RGV arm. h. there is no difference in patient satisfaction or adherence between ATV/r and RGV | — |
Countries
Germany
Outcome results
None listed