Selection of Resistant Mutations to Dolutegravir in PLWH Treated in Mozambique (REDOCH)

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

Status: Enrolling

Conditions: HIV Antiretroviral Therapy (ART) Adherence; HIV

Treatments: Other: Not applicable- observational study

Study type: Observational

Funder types: Other

Identifiers

NCT06607588

REDOCh study

Details and patient eligibility

About

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.

Full 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

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

200 participants in 1 patient group

HIV-1 infected men or women >18 years controlled in the day care center of Chokwé Hospital

Treatment:

Other: Not applicable- observational study