EFFECTIVENESS AND SAFETY IN GENERIC ABACAVIR/LAMIVUDINE AND EFAVIRENZ IN HIV NAIVE PATIENTS

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General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Acronym of Public Title:

EFECTSEGABC

Scientific title:

EFFECTIVENESS AND SAFETY OF GENERIC REGIMEN ABACAVIR/LAMIVUDINE AND EFAVIRENZ IN HIV NAIVE PATIENTS OF THE CORPORACION DE LUCHA CONTRA EL SIDA, SANTIAGO DE CALI-COLOMBIA,2011-2012.

Acronym of Scientific Title:

EFSEGABCLAMEFVCALI

Secondary indentifying numbers:

NOT APPLICABLE

Issuing authority of the secondary identifying numbers:

NOT APPLICABLE

Source(s) of monetary or material support:

CORPORACION DE LUCHA CONTRA EL SIDA UNIVERSIDAD DE ANTIOQUIA FACULTAD DE QUIMICA FARMACEUTICA

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Only approved by Ethics Committees

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

JAIME

Last name:

GALINDO QUINTERO

Medical Specialty :

MD. SPECIALIST OF INTERNAL MEDICINE

Affiliation:

CORPORACION DE LUCHA CONTRA EL SIDA

Postal address:

CARRERA 56 2-120

City:

CALI

País:

COLOMBIA

Zip Code:

760035

Telephone:

+57-25136152

Email address:

centroinvestigaciones@cls.org.co

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

COLOMBIA

Clinical sites:

NOT APPLICABLE

Research ethics committees:

CORPORACION DE LUCHA CONTRA EL SIDA, DECEMBER 1TH, 2010

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Complete

Date of first enrollment:

26/01/2011

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Human Immunodeficiency Viruses

Health condition(s) code:

HIV Infections

Lentivirus Infections

Immunologic Deficiency Syndromes

Sexually Transmitted Diseases, Viral

Intervention(s):

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

Intervention code:

Lamivudine

Anti-HIV Agents

Anti-Retroviral Agents

Anti-Infective Agents

Intervention keyword:

Abacavir Efavirenz therapeutic use

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

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.

Key secondary outcomes:

Adherence to treatment compliance (SMAQ test). Measuring time: at baseline, monthly until 12 months of treatment.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

None

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:

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 (<7.0 gm.) of origin not related to HIV, or of unknown cause, and / or that has not been resolved or is already under specific treatment. 6. Patients with high-sensitivity C-reactive protein (hs-CRP) >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.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

4

Target sample size:

40

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

JAIME

Last Name:

GALINDO QUINTERO

Specialty:

MD. SPECIALIST OF INTERNAL MEDICINE

Affiliation:

CORPORACION DE LUCHA CONTRA EL SIDA

Postal Address:

CARRERA 56 2-120

City:

CALI

País:

COLOMBIA

Zip Code:

760035

Telephone:

+5725136152 572-5136152

Email :

CENTROINVESTIGACIONES@CLS.ORG.CO

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

JAIME

Last Name:

GALINDO QUINTERO

Specialty:

MD. SPECIALIST OF INTERNAL MEDICINE

Affiliation:

CORPORACION DE LUCHA CONTRA EL SIDA

Postal Address:

CARRERA 56 2-120

City:

CALI

País:

COLOMBIA

Zip Code:

760035

Telephone:

+572-5136152

Email :

CENTROINVESTIGACIONES@CLS.ORG.CO

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000202

Date of Registration in Primary Registry:

19/11/2015

Record Verification Date:

2017/02/23

Next update date:

2018/02/23

Link to the spanish version:

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EFFECTIVENESS AND SAFETY IN GENERIC ABACAVIR/LAMIVUDINE AND EFAVIRENZ IN HIV NAIVE PATIENTS

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