Primary Resistance in HIV Patients in Colombia

NCT03957369 | Completed

• 1 other identifier: 212167
• Study Type: observational
• Target: 527
• Locations: 1 country
• Sites: 1

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

Conditions

HIV Infection

Keywords

HIV infection; Primary resistance; Antiretroviral drugs; Colombia; Cross sectional study

Outcome Measures

Primary Outcomes (1)

• Prevalence of primary HIV drug associated resistance in Colombia

  Prevalence estimated by nationwide sampling of adults HIV positive individuals

  November 2019 - December 2020

Secondary Outcomes (3)

• Outcomes by demographic characteristics

  November 2019 - September 2022

• Resistance to integrase

  November 2019 - September 2022

• Correlate of HIV-1 sequencing by Sanger vs Next-Generation Sequencing techniques

  November 2019 - September 2022

Study Arms (1)

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; Diagnostic Test: HIV-1 plasma RNA Genotyping secuencing by Ultra-deep sequencing technique

Interventions

HIV-1 plasma RNA Genotyping secuencing by Sanger technique DIAGNOSTIC_TEST

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.

Also known as: Sanger Sequencing

Adult naive HIV positive individuals

HIV-1 plasma RNA Genotyping secuencing by Ultra-deep sequencing technique DIAGNOSTIC_TEST

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.

Also known as: Next-Generation Sequencing

Adult naive HIV positive individuals

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• \. Patients with any type of antiretroviral exposure

Sponsors & Collaborators

• Fundacion REVIVA, Red de VIH del Valle del Cauca: lead
• ViiV Healthcare: collaborator
• Centro de Investigación en. Enfermedades Infecciosas, Mexico: collaborator

Study Sites (1)

REVIVA, Red de VIH del Valle del Cauca

Cali, Valle del Cauca Department, 760043, Colombia

Location

Biospecimen

Retention: SAMPLES WITH DNA

Collection of whole blood from study subjects from July 2021 thru July 2022, with an estimated sample size of 501 HIV positive naive individuals.

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• ERNESTO MARTINEZ

  Fundacion REVIVA, Red de VIH del Valle del Cauca

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2019
• First Posted: May 21, 2019
• Study Start: December 3, 2020
• Primary Completion: November 30, 2023
• Study Completion: April 1, 2024
• Last Updated: February 19, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)