HIV-1 infection MedDRA version: 14.0 Level: LLT Classification code 10068341 Term: HIV-1 infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Truvada 200mg/ 245mg comprimidos recubiertos con película
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: TENOFOVIR DISOPROXIL FUMARATE
CAS Number: 202138-50-9
Concentration u
Sponsors
Fundació Lluita contra la SIDA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 18 years 2. Chronic HIV-1 infection 3. Antiretroviral treatment with either DRV/r (800/100 mg QD) or LPV/r (400/100 mg BID) monotherapy during at least 6 months prior to screening. 4. Fasting total cholesterol or LDL-cholesterol levels ? 200 and ?130 mg/dL respectively, in the previous two consecutive tests obtained at least 4 weeks apart before screening. 5. Calculated creatinine clearance ? 60 mL/min, according to the Cockcroft-Gault formula. 6. Undetectable plasma HIV-1 RNA levels (=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Acute infections or uncontrolled chronic infection in the 2 months previous to the inclusion or physical examination that, in the investigator's opinion, would compromise the patient's safety or outcome of the study 2. Lactating, pregnancy or fertile women willing to be pregnant. 3. Concomitant use of any drug with potential drug-drug interaction with DRV/r, LPV/r or TDF/FTC co-formulation at study entry. 4. Concomitant use of any lipid-lowering drugs at study entry. 5. Prior documented intolerance or hypersensitivity to TDF, FTC, LPV/r or DRV/r. 6. Therapies including interferon, interleukin-2, cytotoxic chemotherapy or immunosuppressors at study entry. 7. Acute or chronic renal documented pathologies. 8. Documented resistance to any of the study drugs (either genotypic or phenotypic) 9. Life expectancy less or equal to 1 year. 10. Current alcohol or substance use judged by the investigator to potentially interfere with subject study compliance. 11. Subjects currently taking part in any other clinical trial using an investigational product, with the exception of studies where the treatment studied have stopped for more than 12 weeks. 12. Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the cholesterol-lowering ability of TDF/FTC co-formulation in HIV-1-infected subjects with high cholesterol levels.;Primary end point(s): Changes in median fasting total and LDL cholesterol levels during TDF/FTC co-formulation addition compared to placebo.;Timepoint(s) of evaluation of this end point: Every 3 months throughout the study;Secondary Objective: - To assess the ability of TDF/FTC co-formulation to decrease trygliceride levels and increase HDL-cholesterol levels in HIV-1-infected subjects with dyslipidemia. - To evaluate changes in CD4-cell count, liver enzymes, phosphate, creatinine and glomerular filtration rate during the addition of TDF/FTC co-formulation. - To evaluate the rates of sustained RNA HIV viral load suppression <50 copies/mL during the study, particularly during the addition of TDF/FTC co-formulation. - To evaluate adverse events, including laboratory abnormalities. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Percentage of patients with dyslipidemia during TDF/FTC co-formulation addition, compared to placebo. Hypercholesterolemia will be defined according to the National Cholesterol Education Program, ATP III guidelines, i.e.: total cholesterol >= 200 mg/dL, LDL cholesterol >= 130 mg/dL and HDL cholesterol = 50 copies/mL while receiving ART. - Median changes in CD4-cell count, triglycerides, liver enzymes, phosphate, creatinine and glomerular filtration rate during the addition of TDF/FTC. - Percentage of patients with >= grade 3 toxicity. - Percentage of patients who withdraw from the study. - Percentage of patients who withdraw from the study due to toxicity. - Percentage of patients requiring lipid-lowering drugs.;Timepoint(s) of evaluation of this end point: Every 3 months throughout the study | — |
Countries
Spain
Contacts
Public ContactCRA
Fundació Lluita contra la SIDA
Outcome results
None listed