Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03957369 |
| Other study ID # |
212167 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 3, 2020 |
| Est. completion date |
September 30, 2023 |
Study information
| Verified date |
March 2023 |
| Source |
Fundacion REVIVA, Red de VIH del Valle del Cauca |
| Contact |
ERNESTO MARTINEZ, MD |
| Phone |
+573164484799 |
| Email |
emarbui[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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
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.
