HIV-1 infection
Conditions
Interventions
Trade Name: Invirase
Product Name: Saquinavir
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: saquinavir
CAS Number: 149845
Sponsors
IATEC B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Provide written informed consent. •HIV-1 infected patients. •At least 18 years of age. •Males or non-pregnant, non-lactating females. •Anti-retroviral treatment naive. •Indication for antiretroviral therapy according to current treatment guidelines. 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •CD4 count > 350 cells/mm3,, except in case of symptomatic HIV disease and/or an AIDS-defining illness. •HIV-2 co-infection. •Use of co-medication with a known or suspected pharmacological interaction which precludes the appropriate use of one or more of the study drugs. •Anticipated non-compliance with the protocol. •Presence of a newly (within 30 days prior to the time of enrolment) diagnosed HIV-related opportunistic infection or condition which may interfere with the ability to comply with the study. Women who are pregnant, or have the intention to become pregnant during the study period. •Chronic active viral hepatitis or other chronic liver disease, which in the opinion of the investigator is a contraindication for the use of any of the study drugs. Chronic hepatitis C is allowed, provided that treatment for hepatitis C is not anticipated during the study period. •Clinically relevant laboratory abnormalities: anaemia, thrombocytopenia, leucopenia, elevated liver transaminases, elevated bilirubin, elevated amylase, elevated lipase, which in the opinion of the investigator is a contraindication for the use of any of the study drugs. •Significant renal dysfunction (creatinine clearance [CrCl] 3 X ULN and/or documented liver cirrhosis) •Use of nephrotoxic agents which in the opinion of the investigator are a contraindication for the use of tenofovir disoproxil fumarate and any other of the study drugs. •Patients who have received within 4 weeks prior to entry, or who have an anticipated need for treatment with radiation therapy or cytotoxic chemotherapeutic agents during the protocol study period. •Patients who have taken any investigational drug 30 days prior to the start of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This study is primarily designed as a study to assess estimates and confidence intervals for the differences in changes in lipids of patients treated with once-daily antiretroviral therapy containing either saquinavir/r or atazanavir/r both in combination with tenofovir disoproxil fumarate and emtricitabine either in a fixed dose tablet (Truvada®) or dosed separately.; Secondary Objective: •To assess the differences in changes in plasma lipids after once-daily saquinavir/ritonavir (2000/100 mg QD) or atazanavir/ritonavir (300/100 mg QD) each in combination with tenofovir disoproxil fumarate and emtricitabine for 48 weeks. •To compare differences in changes in glucose metabolism. •To compare changes in fat redistribution in both study arms. •To relate differences in changes in lipids, glucose metabolism and abdominal fat distribution to the plasma exposure of the different protease inhibitors (including ritonavir) used in the trial. •To assess the change in estimated glomerular filtration rate (GFR) by Cockcroft-Gault, MDRD and cystatin C-derived equations in both study arms. •To compare the antiviral efficacy of both regimens. ;Primary end point(s): Estimates and 95% confidence intervals of the difference between the sanquinavir (SQV) arm and the atazanavir (ATV) arm of changes in total cholesterol, triglycerides, HDL, and LDL after 24 weeks. | — |
Countries
Germany, United Kingdom
Outcome results
None listed