Clinical trial NCT03957369: Primary Resistance in HIV Patients in Colombia
Official title: Prevalence of NRTI, NNRTI, PI and INSTI Primary Resistance-Associated Mutations of Adult Naïve HIV-1 Seropositive Patients in Colombia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infection
Keywords: HIV infection
Primary resistance
Antiretroviral drugs
Colombia
Cross sectional study
Lead sponsor: Fundacion REVIVA, Red de VIH del Valle del Cauca
Sponsor class: NETWORK
Collaborators: name: ViiV Healthcare
name: Centro de Investigación en. Enfermedades Infecciosas, Mexico
First posted: 2019-05-21
Enrollment: 527
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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

Brief summary: 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of primary HIV drug associated resistance in Colombia
timeFrame: November 2019 - December 2020
Secondary outcomes:
measure: Outcomes by demographic characteristics
timeFrame: November 2019 - September 2022
measure: Resistance to integrase
timeFrame: November 2019 - September 2022
measure: Correlate of HIV-1 sequencing by Sanger vs Next-Generation Sequencing techniques
timeFrame: November 2019 - September 2022
Other outcomes:
Locations:
city: Cali
country: Colombia
facility: REVIVA, Red de VIH del Valle del Cauca
state: Valle
Study officials:
affiliation: Fundacion REVIVA, Red de VIH del Valle del Cauca
name: ERNESTO MARTINEZ
role: PRINCIPAL_INVESTIGATOR
References: