Human Immunodeficiency Viruses
Conditions
Interventions
Lamivudine 300 mg/Abacavir 600 mg (LAMCAVIR 1 tablet daily), by oral route for 12 months and Efavirenz 600 mg (1 tablet daily) by oral route for 12 months
Lamivudine
Anti-Infective Agents
Abacavir
Efavirenz
therapeutic use
Sponsors
CORPORACION DE LUCHA CONTRA EL SIDA
UNIVERSIDAD DE ANTIOQUIA FACULTAD DE QUIMICA FARMACEUTICA
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Adult patients (> 18 years) who agree to participate by informed consent. The patients belong to the Comprehensive Outpatient Specialty Care Corporation Fight Against AIDS; diagnosed as HIV +, by laboratory testing (presumptive tests and confirmatory test, numbers of CD4 lymphocyte cells / mm3 and percentage by flow cytometry, and viral load values in virus copies / mL by PCR assay in real time reverse transcriptase. 2. Patients with viral load less than 100,000 copies at the beginning of the study (maximum taken one month before) 3. Genotyping result of negative resistance (analyzed and interpreted under the latest recommendations in the world for the management of HIV infection), without clinical/epidemiological evidence of a possible involvement of drug susceptibility under study. 4. Patients with documented absence of HLA B57 marker at the beginning of the study. 5. Cardiovascular (CV) risk assessed as low (<10%), using the Framingham risk score and, absence of metabolic syndrome or diabetes and cardiovascular disease, current or past. 6. Patients who clinically and according to the recommendations 2010 of the Corporation for AIDS and supported by the most current recommendations for beginning such treatment in the world require, are willing to comply with the antiretroviral treatment under study and, they not have any antiretroviral treatment previous.
Exclusion criteria
Exclusion criteria: 1. Patients with renal failure (serum creatinine equal to an estimate of less than 60 mL / min creatinine clearance). 2. Patients with primary liver failure or associated with another disease. 3. Women who are pregnant or lactating, or of childbearing age not using a safe method of contraception. 4. Patients who use drugs or require it and the drugs have high likelihood of clinically relevant interactions (such as rifampicin, itraconazole). 5. Severe anemia (2.0 mg/L, and at least two of the following CV risk factors: 1) smoking, 2) total cholesterol (TC) =240 mg/dL, 3) triglycerides >200 mg/dL, 4) high-density lipoprotein cholesterol (HDL-C) =40 mg/dL, 5) glycemia >110 mg/dL, or 6) large waist circumference and waist/hip ratio (men with waist circumference >102 cm and waist/hip ratio >0.9 or women with waist circumference >88 cm and waist/hip ratio >0.8) 7. Patients with three of the 6 CV risk factors cited above even hs-CRP) <2.0 mg/L or normal. 8. Patients who are hospitalized. 9. Patients with major psychiatric disorders. 10. Patients with current or past medical history of substance abuse without intervention 11. Patients with variable work schedules that include night shifts.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effectiveness assessment: CD4 cell count (cells/mm3). Measuring time: at baseline, 3, 6, and 12 months of treatment. Viral Load (RNA copies/mL). Measuring time: at baseline, 3, 6, and 12 months of treatment. Safety assessment: Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters (U/L). Measuring time: at baseline, 1, 3, 6, and 12 months of treatment. Creatinine (mg/dL).Measuring time: at baseline, 1, 3, 6, and 12 months of treatment. Lipid profile (mg/dL).Measuring time: at baseline, 1, 3, 6, and 12 months of treatment. Glucose (mg/dL).Measuring time: at baseline, 1, 3, 6, and 12 months of treatment. Anthropometric measurements (Weight (kg), Height (m), Waist sizet (cm)).Measuring time: at baseline, 1, 3, 6, and 12 months of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Adherence to treatment compliance (SMAQ test). Measuring time: at baseline, monthly until 12 months of treatment. | — |
Countries
COLOMBIA
Contacts
Public ContactJAIME GALINDO QUINTERO
CORPORACION DE LUCHA CONTRA EL SIDA
Outcome results
None listed