HIV InfectionNCT03957369
Primary Resistance in HIV Patients in Colombia
An observational study of HIV Infection, run by Fundacion REVIVA, Red de VIH del Valle del Cauca at 1 site in Colombia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection
- What is being tested?
- HIV-1 plasma RNA Genotyping secuencing by Sanger technique and HIV-1 plasma RNA Genotyping secuencing by Ultra-deep sequencing technique
- How many people
- 527 participants
- Where
- 1 siteColombia
- Study dates
- 3 Dec 2020to 1 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with HIV infection not exposed to any HIV antiretroviral drugs, regardless of the time of the HIV diagnosis
Who may be able to join
- Naive HIV-positive individuals aged 18 years or older.
- Consent to participate in the research.
Who cannot join
- 1. Patients with any type of antiretroviral exposure
Trial locations and contacts
1 site in 1 country.
Colombia1 site
REVIVA, Red de VIH del Valle del Cauca
Cali, Valle del Cauca Department, 760043
About this study
Official title: 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
Read the 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:
- Patients will be chosen based on the opportunity to attend the healthcare provider institutions (IPS) if they meet the inclusion criteria.
- 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.
- 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.
- Conditions
- HIV Infection
- Being tested
- HIV-1 plasma RNA Genotyping secuencing by Sanger technique, HIV-1 plasma RNA Genotyping secuencing by Ultra-deep sequencing technique
- Keywords
- HIV infection, Primary resistance, Antiretroviral drugs, Colombia, Cross sectional study
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV-1 plasma RNA Genotyping secuencing by Sanger techniqueDiagnostic test
Also called Sanger Sequencing
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.
HIV-1 plasma RNA Genotyping secuencing by Ultra-deep sequencing techniqueDiagnostic test
Also called Next-Generation Sequencing
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.
| Study group | Role | What they receive |
|---|---|---|
| Adult naive HIV positive individuals | HIV-diagnosed subjects, older than 18 years, with no prior exposure to antiretroviral drugs. Receives: Diagnostic Test: HIV-1 plasma RNA Genotyping secuencing by Sanger technique; Diagnostic Test: HIV-1 plasma RNA Genotyping secuencing by Ultra-deep sequencing technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of primary HIV drug associated resistance in Colombia
Prevalence estimated by nationwide sampling of adults HIV positive individuals
Measured: November 2019 - December 2020
Secondary outcomes (3)
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
Measured: November 2019 - September 2022
Resistance to integrase
Determine the presence of RAMs to integrase to correlate with primary resistance to integrase inhibitors in Colombia
Measured: 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
Measured: November 2019 - September 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start3 Dec 2020
- Primary completion30 Nov 2023
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 527 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion REVIVA, Red de VIH del Valle del Cauca
- Sponsor type
- Research network
- Collaborators
- ViiV Healthcare, Centro de Investigación en. Enfermedades Infecciosas, Mexico
- Responsible party
- Sponsor
- Investigators
- ERNESTO MARTINEZ, Principal investigator, Fundacion REVIVA, Red de VIH del Valle del Cauca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03957369
- Sponsor's protocol ID
- 212167
- Status last verified
- Apr 2024
- First submitted
- 17 May 2019
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of NRTI, NNRTI, PI and INSTI Primary Resistance-Associated Mutations of Adult Naïve HIV-1 Seropositive Patients in Colombia
- ClinicalTrials.gov ID
- NCT03957369
- Acronym / sponsor ID
- 212167
- Conditions
- HIV Infection
- Keywords
- HIV infection, Primary resistance, Antiretroviral drugs, Colombia, Cross sectional study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 527 participants (actual)
- Lead sponsor
- Fundacion REVIVA, Red de VIH del Valle del CaucaResearch network
- Collaborators
- ViiV Healthcare, Centro de Investigación en. Enfermedades Infecciosas, Mexico
- Study start
- 3 Dec 2020 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 21 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Patients will be chosen based on the opportunity to attend the healthcare provider institutions (IPS) if they meet the inclusion criteria.
- 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.
- 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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult naive HIV positive individuals | – | Diagnostic Test: HIV-1 plasma RNA Genotyping secuencing by Sanger technique, Diagnostic Test: HIV-1 plasma RNA Genotyping secuencing by Ultra-deep sequencing techniqueHIV-diagnosed subjects, older than 18 years, with no prior exposure to antiretroviral drugs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with HIV infection not exposed to any HIV antiretroviral drugs, regardless of the time of the HIV diagnosis
Key inclusion criteria (2 listed)
- Naive HIV-positive individuals aged 18 years or older.
- Consent to participate in the research.
Key exclusion criteria (1 listed)
- 1. Patients with any type of antiretroviral exposure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIV-1 plasma RNA Genotyping secuencing by Sanger techniqueAlso: Sanger SequencingAfter 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. | Diagnostic test | Adult naive HIV positive individuals |
| HIV-1 plasma RNA Genotyping secuencing by Ultra-deep sequencing techniqueAlso: Next-Generation SequencingAfter 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. | Diagnostic test | Adult naive HIV positive individuals |
Primary outcome
Prevalence of primary HIV drug associated resistance in Colombia
Time frame: November 2019 - December 2020
Prevalence estimated by nationwide sampling of adults HIV positive individuals
3 secondary outcomes
Outcomes by demographic characteristics
Time frame: November 2019 - September 2022
Resistance to integrase
Time frame: November 2019 - September 2022
Correlate of HIV-1 sequencing by Sanger vs Next-Generation Sequencing techniques
Time frame: November 2019 - September 2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ERNESTO MARTINEZ principal investigator
Fundacion REVIVA, Red de VIH del Valle del Cauca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infection, run by Fundacion REVIVA, Red de VIH del Valle del Cauca at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of primary HIV drug associated resistance in Colombia (time frame: November 2019 - December 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.