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

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.

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.

Secondary indentifying numbers:

UTN: U1111-1130-8685

Source(s) of monetary or material support:

Corporación de Lucha Contra el Sida HUMAX FARMACÉUTICA.

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:

Corporación de Lucha Contra el Sida

Postal address:

Carrera 56 # 2-120

City:

Cali

País:

Colombia

Zip Code:

760020

Telephone:

+57-25136152

Email address:

centroinvestigaciones@cls.org.co [1]

jaimegalindo@cls.org.co [2]

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:

Corporación de Lucha Contra el Sida, 18 de abril de 2012 (IRB00005732 - Act 024)

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

15/08/2012

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:

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

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):

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

Key secondary outcomes:

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.

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:

65 years

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.

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:

Non-randomized controlled trial

Masking:

Open

Control group:

Active

Study design:

Parallel

Phase:

Target sample size:

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:

Corporación de Lucha Contra el Sida

Postal Address:

Carrera 56 2-120, Cali-Colombia.

City:

Santiago de Cali

País:

Colombia

Zip Code:

760020

Telephone:

752-5136152

Email :

jaimegalindo@cls.org.co [2]

centroinvestigaciones@cls.org.co [1]

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:

Corporación de Lucha Contra el Sida

Postal Address:

Carrera 56 2-120, Cali-Colombia.

City:

Santiago de Cali

País:

Colombia

Zip Code:

760020

Telephone:

752-5136152

Email :

jaimegalindo@cls.org.co [2]

centroinvestigaciones@cls.org.co [1]

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:

RPCEC00000134

Date of Registration in Primary Registry:

2012-07-20

Record Verification Date:

2015/08/04

Next update date:

2016/08/04

Link to the spanish version:

Click here [3]