tratement HIV infection
Conditions
Interventions
Trade Name: KIVEXA( Abacavir 600 mg/ Lamivudine 300 mg) recovered tablets
Product Name: CoatedTablet600 mg de abacavir ( sulfate) 300 mg de lamivudine
Pharmaceutical Form: Coated tablet
INN or Propose
Sponsors
Fundació Clínic per a la Recerca Biomèdica
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. chronic infection by HIV-1. 2. equal to or more than 18 years old. 3 that you have not previously received anti-retroviral treatment. 4 digit baseline CD4 count 100 Celsµl (confirmed by two determinations). 5 result of baseline genotypic resistance study showing absence of mutations of resistance to drugs in the study. 6 that, properly informed, you grant your consent in writing to participate in the study and submit to the tests and scans that entails. 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 108 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Known hypersensitivity to drugs in the study. 2. hypersensitivity documented to sulfonamides and derivatives. 3 positivity in the determination of the HLA B5701. 4 pregnant women, nursing mothers, or those who intend to become pregnant during the study period. 5 lymphomas and other active Neoplasms that require chemotherapy. 6. less than 50 mlmin creatinine clearance. 7 liver failure moderate or severe (Child-Pugh classification C class). 8 ALT ?5 times the upper limit of normal (ULN), or ALT ?3 times the ULN and total bilirubin ?1, 5 times the ULN (with 35 of direct bilirubin). 9. need for treatment of HCV during the study. 10. current or recent treatment with nephrotoxic drugs. 11. treatment with immunomodulators, or products under investigation. 12. treatment with drugs or products whose pharmacokinetic interaction potential decrease efficiency or increase the toxicity of antiretroviral drugs in the study. 13. any formal contraindication to be treated with the drugs in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -Compare the change in the absolute number of CD4 in peripheral blood to 48 to 96 weeks of initiating treatment.;Secondary Objective: -Compare the proportion of patients with undetectable viral load at 48 and 96 weeks. -Compare the proportion of patients with CD4 above 200 celsmm3 to the 48 and 96 weeks of initiating treatment. -Compare the change in the parameters of immune activation (especially in CD8 and CD8CD38 cells). -Compare the change in the parameters of bacterial translocation (sCD14), inflammation (IL.6, TNF-alpha and ultrasensitive PCR) and coagulation (Dimer-D). -To compare the changes in the intestinal Microbiome. -Describe the proportion of patients who develop (SIRI) immune reconstitution syndrome. -Describe the clinical tolerability and toxicity of the three guidelines. -Describe the plasma lipid profile. -Determine the pattern of mutations of resistance in cases of treatment failure. -To compare the rate of progression of the disease and survival.;Primary end point(s): Compare the change in the absolute number of CD4 in peripheral blood to 48 to 96 weeks of initiating treatment.;Timepoint(s) of evaluation of this end point: Average increase in the absolute number of CD4 in peripheral blood to 48 to 96 weeks of initiating treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Compare the proportion of patients with undetectable viral load at 48 and 96 weeks. -Compare the proportion of patients with CD4 above 200 celsmm3 to the 48 and 96 weeks of initiating treatment. -Compare the change in the parameters of immune activation (especially in CD8 and CD8CD38 cells). -Compare the change in the parameters of bacterial translocation (sCD14), inflammation (IL.6, TNF-alpha and ultrasensitive PCR) and coagulation (Dimer-D). -To compare the changes in the intestinal Microbiome. -Describe the proportion of patients who develop (SIRI) immune reconstitution syndrome. -Describe the clinical tolerability and toxicity of the three guidelines. -Describe the plasma lipid profile. -Determine the pattern of mutations of resistance in cases of treatment failure. -To compare the rate of progression of the disease and survival.;Timepoint(s) of evaluation of this end point: Proportion of patients presenting with undetectable viral load (50 copiasmL or ultrasensitive) after 48 and 96 weeks for inclusion in the study. -Proportion of patients with CD4 above 200 celsmm3 to the 48 and 96 weeks of initiating treatment. -Compare the change in cells CD8 and CD8CD38 48 and 96 weeks of initiating treatment. - -Proportion of patients with immune reconstitution syndrome. -Incidence of clinical adverse events and laboratory abnormalities causing the withdrawal of treatment in study. -Changes in triglycerides, total cholesterol and HDL and LDL cholesterol. -Incidence and type of resistance mutations in patients presenting virologic failure. -Rate of progression to AIDS and death. | — |
Countries
Spain
Contacts
Public ContactAnna Cruceta
CTU Clinic (Clinical Trial Unit)
Outcome results
None listed