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Selection of Resistant Mutations to Dolutegravir in PLWH Treated in Mozambique

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06607588
Acronym
REDOCH
Enrollment
200
Registered
2024-09-23
Start date
2024-10-25
Completion date
2026-09-30
Last updated
2025-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV, HIV Antiretroviral Therapy (ART) Adherence

Keywords

HIV, ARV, Resistance, DTG, Africa

Brief summary

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.

Detailed description

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

Interventions

OTHERNot applicable- observational study

Not applicable- observational study

Sponsors

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

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Selection of DRM to dolutegravir and/or tenofovir and/or lamivudine3 months% of Selection of DRM to dolutegravir and/or tenofovir and/or lamivudine

Countries

Mozambique

Contacts

Primary ContactDaniel Podzamczer, PhD
dpodzamczer@gmail.com0034675335888
Backup ContactAntonio Navarro, MSc
anavarro@igtp.cat+0034675335888

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026