Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06607588

Selection of Resistant Mutations to Dolutegravir in PLWH Treated in Mozambique

The HIV infection not fully controlled, despite being under antiretroviral treatment, could make virus resistance against the antiretroviral treatments, making hardest the well control of HIV infection. The purpose of this research study is to confirm or deny if a not fully good controlled HIV infection could develop virus resistance against antiretroviral drugs that can difficult the good control of the HIV infection.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Carmelo

Chokwé, F2C3+JPR, Mozambique

Location status: Recruiting

Location contact

Elsa Jordao, MD

CONTACT

[email protected]

+2587190700

About this study

This research study consists of a single visit, in which you will be taken an additional vial of blood to analyze the presence or absence of mutations in your virus to HIV drugs. In addition, other HIV infection routine information will be recorded:

  • Demographic data
  • HIV infection history data
  • Virological failure information
  • Laboratory parameters Resistance tests techniques: Genotyping resistance test will be performed from plasma samples in those patients with viral load over 200 copies/ml, using ultracentrifugation if needed (Inzaule, Seth C et al. J Antimicrob Chemother, 2018). Briefly, RNA will be extracted and HIV-1 pol gene will be amplified, followed by a nested-PCR. Amplification products will be purified, quantified and finally diluted and prepared for sequencing following Illumina DNA Sample Preparation Kit protocol (Illumina, San Diego, CA). Samples will finally be pooled and sequenced in a MiSeq System (Illumina). MiSeq sequences will be downloaded from Basespace (Illumina) and analysed using PASeq (IrsiCaixa,Barcelona,ES), v1.4.18 (https://www.paseq.org). The questionnaire about clinical and demographic characteristics will be performed during the study visit

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients able to understand and sign the informed consent form.
  • Documented HIV-1 infection.
  • Under the first line TLD for at least 6 months.
  • At least 3 months follow-up with CV >200c/ml.

Exclusion criteria

  • Patients <18 years of age.
  • Under the first line regime other than TLD.
  • Patients with active neoplastic processes.
  • Patients with active opportunistic diseases.
  • Patients unable to give informed consent.

Treatment and study plan

Not applicable- observational study

Other

Not applicable- observational study

Primary outcomes

  1. Selection of DRM to dolutegravir and/or tenofovir and/or lamivudine

    Time frame: 3 months

    % of Selection of DRM to dolutegravir and/or tenofovir and/or lamivudine

Study contacts

Contact information is provided by the study sponsor or research team.

Antonio Navarro, MSc

CONTACT

[email protected]

+0034675335888

Daniel Podzamczer, PhD

CONTACT

[email protected]

0034675335888

Sponsors and collaborators

Lead sponsor

Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

Other

Registry information

Official study title

Selection of Resistant Mutations to Dolutegravir and Associated Drugs in PLWH Treated in Clinical Practice in Chokwé, Mozambique

Acronym: REDOCH

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 23, 2024
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.