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

• Register: RPCEC
• Last refreshed on: 29 April 2024
• Main ID: RPCEC00000202
• Date of registration: 19/11/2015
• Prospective Registration: No
• Primary sponsor: CORPORACION DE LUCHA CONTRA EL SIDA
• Public title: EFFECTIVENESS AND SAFETY IN GENERIC ABACAVIR/LAMIVUDINE AND EFAVIRENZ IN HIV NAIVE PATIENTS
• 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. - EFSEGABCLAMEFVCALI
• Date of first enrolment: 26/01/2011
• Target sample size: 40
• Recruitment status: Complete
• URL: https://rpcec.sld.cu/en/trials/RPCEC00000202-En
• Study type: Interventional
• Study design: Allocation: N/A: single arm study. Masking: Open. Control group: Uncontrolled. Assignment: Single group. Purpose: Treatment
• Phase: 4

Countries of recruitment

COLOMBIA

Contacts

• Name: JAIME GALINDO QUINTERO
• Affiliation: CORPORACION DE LUCHA CONTRA EL SIDA

• Name: JAIME GALINDO QUINTERO
• Affiliation: CORPORACION DE LUCHA CONTRA EL SIDA

Key inclusion & exclusion 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: 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.

Age minimum: 18 years
Age maximum: None
Gender: Male/Female

Health Condition(s) or Problem(s) studied

Human Immunodeficiency Viruses

HIV Infections

Immunologic Deficiency Syndromes

Lentivirus Infections

Sexually Transmitted Diseases, Viral

Intervention(s)

Abacavir
Efavirenz
therapeutic use

Anti-Retroviral Agents

Lamivudine

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

Anti-HIV Agents

Anti-Infective Agents

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.

Secondary Outcome(s)

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

Secondary ID(s)

NOT APPLICABLE

Source(s) of Monetary Support

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

Secondary Sponsor(s)

UNIVERSIDAD DE ANTIOQUIA FACULTAD DE QUIMICA FARMACEUTICA