Primary Resistance in HIV Patients in Colombia

Prevalence of NRTI, NNRTI, PI and INSTI Primary Resistance-Associated Mutations of Adult Naïve HIV-1 Seropositive Patients in Colombia

The investigators' main objective is to determine the prevalence of pre-treatment of resistance-associated mutations (RAMs) in a naïve and recently diagnosed HIV infection in 18 centers from 12 cities in Colombia. This evaluation will include the genotyping of all three enzymes, reverse transcriptase, protease, and integrase. This type of complete primary resistance profile has not yet been reported in Colombia and there is only scanty data regarding resistance-associated mutations to NRTIs, NNRTIs, and PIs in the country

Study Overview

• Status: Recruiting
• Conditions: HIV Infection
• Intervention / Treatment: Diagnostic test: HIV-1 plasma RNA Genotyping secuencing by Sanger technique; Diagnostic test: HIV-1 plasma RNA Genotyping secuencing by Ultra-deep sequencing technique

Detailed Description

The number of patients and sample size:

The proportion formula for finite populations was used to determine the sample size (with appropriate confidence intervals) needed to find the prevalence of RAMs in naive HIV population from Colombia.

As shown below, estimating 20% of loss, the sample size will be 500 study subjects considering a CI 97%.

The sample size is estimated in 501 patients, considering 1% or less of the probability of finding pre-treatment resistance-associated mutations affecting integrase inhibitors, a CI of 97%, and 20% of blood samples loss or not processable.

Sample selection:

The investigators chose 12 cities (Bogotá, Cali, Medellín, Barranquilla, Montería, Cartagena, Bucaramanga, Cúcuta, Pereira, Villavicencio, Pasto, and Florencia) in which the majority of the HIV population is found in Colombia, accounting for around 80% according to data from the High-Cost Account (CAC, in its Spanish acronym) 2016. Moreover, this allows the selection of patients with diverse races or ethnic groups.

The healthcare provider institutions (Instituciones Prestadoras de Salud - IPS in Spanish) with integral HIV care programs in accordance with the quality and service requirements demanded by the Colombian Ministry of Social Protection.

The sample will be selected as follows:

1. Patients will be chosen based on the opportunity to attend the healthcare provider institutions (IPS) if they meet the inclusion criteria.
2. Treating physicians in charge of HIV care in the healthcare provider institutions will invite patients to participate upon explanation of the nature, purposes, and benefits of the study. If a patient agrees to participate, informed consent will be asked. Once this consent is given and the respective written form is signed, the collection of data will be collected and a blood sample will be drawn.
3. If a patient has signed the written informed consent form but does not provide the blood sample, he or she will be excluded and another patient will be expected to be included in order to complete the sample size calculated for the study.

Data collection:

A unique identification code, assigned to each patient, will be registered in the case report forms and in the laboratory report. The research group will keep the absolute privacy of collected data that relates the patient's name with the identification code.

Procedures for primary resistance-associated mutations determination in the blood samples:

Genotyping sequencing will be performed using traditional and ultradeep sequencing techniques in plasma samples by Sanger and Next-Generation Sequencing, respectively. Stanford database analysis criteria will be used to compare the performance of these techniques. Both techniques will be performed in all samples.

Plasma samples will be sent for processing for both techniques at Centro de Investigación en Enfermedades Infecciosas - CIENI in Mexico City.

• Study Type: Observational
• Enrollment (Anticipated): 501

Contacts and Locations

• Study Contact: Name: ERNESTO MARTINEZ, MD; Phone Number: +573164484799; Email: emarbui@gmail.com
• Study Contact Backup: Name: ERNESTO M B., RPT; Phone Number: +57 3006005299; Email: Emarbui@gmail.com

Study Locations

• Colombia
  • Valle
    • Cali, Valle, Colombia, 760043
      • Recruiting
      • REVIVA, Red de VIH del Valle del Cauca
      • Contact: ERNESTO MARTINEZ, MD; Phone Number: +57 3164484799; Email: emarbui@gmail.com
      • Contact: LUZ M SAÑUDO, RPT; Phone Number: +57 3006005299; Email: luzma56@gmail.com
      • Sub-Investigator: JOSE M OÑATE, MD
      • Sub-Investigator: JOSE F GARCÍA-GOEZ, MD
      • Sub-Investigator: WILLIAM LENIS, MD
      • Sub-Investigator: LUISA C CONSUELO, MD, MSc
      • Sub-Investigator: JORGE ALVAREZ, MD
      • Sub-Investigator: ANDRES F ZAPATA, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adults with HIV infection not exposed to any HIV antiretroviral drugs, regardless of the time of the HIV diagnosis

Description

Inclusion Criteria:

1. Naive HIV-positive individuals aged 18 years or older.
2. Consent to participate in the research.

Exclusion Criteria:

1. Patients with any type of antiretroviral exposure

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Adult naive HIV positive individuals; HIV-diagnosed subjects, older than 18 years, with no prior exposure to antiretroviral drugs.

Diagnostic test: HIV-1 plasma RNA Genotyping secuencing by Sanger technique; After signing informed consent, we will collect whole blood for HIV genotyping in plasma HIV-1 RNA for testing of resistance-associated mutations to reverse transcriptase, protease, and integrase enzymes.; Other Names: Sanger Sequencing; Diagnostic test: HIV-1 plasma RNA Genotyping secuencing by Ultra-deep sequencing technique; After signing informed consent, we will collect whole blood for HIV genotyping in plasma HIV-1 RNA for testing of resistance-associated mutations to reverse transcriptase, protease, and integrase enzymes.; Other Names: Next-Generation Sequencing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of primary HIV drug associated resistance in Colombia	Prevalence estimated by nationwide sampling of adults HIV positive individuals	November 2019 - December 2020

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Outcomes by demographic characteristics	Estimate HIV drug resistance by age, sex, race and ethnic groups overall and in each of the different included Colombian regions and 12 Colombian cities	November 2019 - September 2022
Resistance to integrase	Determine the presence of RAMs to integrase to correlate with primary resistance to integrase inhibitors in Colombia	November 2019 - September 2022
Correlate of HIV-1 sequencing by Sanger vs Next-Generation Sequencing techniques	Compare the results from sequencing plasma HIV-1 RNA by both proposed techniques	November 2019 - September 2022

Collaborators and Investigators

• Sponsor: Fundacion REVIVA, Red de VIH del Valle del Cauca
• Collaborators: ViiV Healthcare; Centro de Investigación en. Enfermedades Infecciosas, Mexico
• Investigators: Principal Investigator: ERNESTO MARTINEZ, Fundacion REVIVA, Red de VIH del Valle del Cauca

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2020
• Primary Completion (Anticipated): July 30, 2023
• Study Completion (Anticipated): September 30, 2023

Study Registration Dates

• First Submitted: May 17, 2019
• First Submitted That Met QC Criteria: May 17, 2019
• First Posted (Actual): May 21, 2019

Study Record Updates

• Last Update Posted (Actual): March 29, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: HIV infection; Colombia; Cross sectional study; Primary resistance; Antiretroviral drugs
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: 212167

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No