Effectiveness and Safety of Tenofovir + Lamivudine + Efavirenz Generic Scheme for the Treatment of HIV Infection / AIDS in Patients of the CLS,Colombia, 2012-2013.

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000134
• Date of registration: 20/07/2012
• Primary sponsor: Corporación de Lucha Contra el Sida
• Public title: Effectiveness and Safety of Tenofovir + Lamivudine + Efavirenz Generic Scheme for the Treatment of HIV Infection / AIDS in Patients of the CLS,Colombia, 2012-2013.
• Scientific title: Effectiveness and safety of tenofovir + lamivudine + efavirenz generic scheme for the treatment of HIV infection / AIDS in patients of the Corporacion de lucha contra el Sida, Santiago de Cali-Colombia, 2012-2013.
• Date of first enrolment: 15/08/2012
• Target sample size: 80
• Recruitment status: Active
• URL: http://registroclinico.sld.cu/trials/RPCEC00000134-En
• Study type: Interventional
• Study design: Randomization: Nonrandomized Trial Blinding: Open. Placebo: Active Assignment: Parallel Purpose: Treatment

Countries of recruitment

Colombia

Contacts

• Name: Jaime Galindo-Quintero
• Affiliation: Corporación de Lucha Contra el Sida

• Name: Jaime Galindo-Quintero
• Affiliation: Corporación de Lucha Contra el Sida

Key inclusion & exclusion criteria

Inclusion criteria: 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.
Exclusion criteria: 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.

Age minimum: 18 years
Age maximum: 65 years
Gender: Both

Health Condition(s) or Problem(s) studied

HIV/AIDS

Intervention(s)

Generic scheme of treatment in Study: Tenofovir 300 mg (1 tablet daily) + lamivudine 150 mg (2 tablets a day) + Efavirenz 600 mg (1 tablet per day). This treatment will apply to two groups of patients: Group 1 (n1=40). Patients diagnosed as HIV+ by laboratory test and clinical findings who need antiretroviral treatment and have not yet started Group 2 (n2=40). Patients who need optimized antiretroviral treatment

Primary Outcome(s)

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(s)

Liver 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.

Secondary ID(s)

UTN: U1111-1130-8685

Source(s) of Monetary Support

Corporación de Lucha Contra el Sida HUMAX FARMACÉUTICA.

Secondary Sponsor(s)

HUMAX FARMACÉUTICA.