Selection of Resistant Mutations to Dolutegravir in PLWH Treated in Mozambique

Recruiting

• Conditions: HIV; HIV Antiretroviral Therapy (ART) Adherence
• Interventions: Other: Not applicable- observational study

• Registration Number: NCT06607588
• Lead Sponsor: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

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

Study Timeline

• Study First Submitted: 2024-09-17
• Study First Submitted QC: 2024-09-18
• Study First Posted: 2024-09-23
• Study Start: 2024-10-25
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-15
• Primary Completion: 2026-04
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HIV-1 infected men or women >18 years controlled in the day care center of Chokwé Hospital	Not applicable- observational study	-

Primary Outcome Measures

Name	Time	Method
Selection of DRM to dolutegravir and/or tenofovir and/or lamivudine	3 months	% of Selection of DRM to dolutegravir and/or tenofovir and/or lamivudine

Trial Locations

Locations (1)

Hospital Carmelo; 🇲🇿 Chokwe, Mozambique