Effectiveness and Safety of Tenofovir + Lamivudine + Efavirenz Generic Scheme for the Treatment of HIV Infection / AIDS in Patients of the CLS,Colombia, 2012-2013.
- Conditions
- HIV/AIDS
- Registration Number
- RPCEC00000134
- Lead Sponsor
- Corporación de Lucha Contra el Sida
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 80
1) Outpatient adults (> 18 years), who agree to participate through informed consent, in the Program for Comprehensive Care Specialized Ambulatory of Corporación de Lucha contra el Sida diagnosed as HIV +, by laboratory testing (presumptive tests and confirmatory test, count of CD4 cells and percentage by flow cytometry and viral load values by virus copies/mL with PCR assay in reverse transcriptase real-time.
2) With the result of negative resistance genotypic study (analyzed and interpreted under the most current recommendations for the management of HIV infection in the world), and/or without clinical/epidemiological evidence of any possible effects of the susceptibility of the drugs under study.
3) Patients without past or present renal disease
4) Patients without prior exposure to ARVs, or with previous exposure to ARV first line (2 NRTIs + 1 NNRTI + Boosted PI) successful (maximum constant viral suppression), without therapeutic failure but with the appearance of a side or undesirable effects attributable(s) primarily to NRTIs used (such as severe gastrointestinal intolerance, blood disorders, lipid and cardiovascular risk changes, lipoatrophy, lactic acidosis, risk or occurrence of hypersensitivity reactions, etc.).
5) That clinically and by guides(2011-2012) of the Corporación de Lucha contra el Sida and supported by the latest recommendations for the initiation of such treatment in the world that they are willing to comply with this ARV treatment and they don't start it o receive previously.
1) Patients with renal failure (serum creatinine equivalent to an estimated creatinine clearance less than 60 mL/ minute). Patients with serum creatinine greater than 1.5 mg%. 2) Patients with liver failure associated with primary or other disease. 3) women who are pregnant or lactating, or of childbearing age without contraception permanent or safer method. 4) Patients who are using drugs or require a high probability of clinically relevant interactions (such as Rifampicin, Itraconazole, etc.). 5) Patients hospitalized. 6) Patients with major psychiatric disorders. 7) Patients with a history and / or substance abuse problems not intervened. 8) Patients with variable work schedules that include night shifts.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Virological status (viral load). Measurement time: at baseline, 3, 6, 12 months of treatment. Immunological status (CD4+ cell count). Measurement time: at baseline, 3, 6, 12 months of treatment. Frequency of adverse reactions to antiretrovirals (Description of the reactions, the severity of the reaction and its possible association with antiretroviral drugs, most convenient solution (symptomatic, adjustment of medication schedules, interruption and / or replacement of treatment)). Measurement time: at baseline,, 3, 6, 12 months of treatment
- Secondary Outcome Measures
Name Time Method iver test (Transaminases). Measurement time: at baseline, 3, 6, 12 months of treatment. Renal test (Creatinine, Urinalysis, Calciuria, phosphate. If phosphatemia and calciuria are abnormal, then the bone densitometry will be done). Measurement time: at baseline, 3, 6, 12 months of treatment. Hematologic test (Complete blood count: hemoglobin, hematocrit, corpuscular volume, total leukocyte and neutrophil differential cell count, platelet count). Measurement time: at baseline, 3, 6, 12 months of treatment. Metabolic function test and anthropometric measurements (glucose, total cholesterol, HDL, LDL, blood pressure index, triglycerides, weight in kilograms, height in centimeters, body mass index, blood pressure, waist circumference). Measurement time: at baseline, 3, 6, 12 months of treatment.