Clinical trial NCT06607588: Selection of Resistant Mutations to Dolutegravir in PLWH Treated in Mozambique
Official title: Selection of Resistant Mutations to Dolutegravir and Associated Drugs in PLWH Treated in Clinical Practice in Chokwé, Mozambique
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HIV
HIV Antiretroviral Therapy (ART) Adherence
Keywords: HIV
ARV
Resistance
DTG
Africa
Lead sponsor: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Sponsor class: OTHER
First posted: 2024-09-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: HIV-1 infected men or women \&amp;gt;18 years controlled in the day care center of Chokwé Hospital

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

Eligibility criteria: 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 \&amp;amp;gt;200c/ml.

Exclusion Criteria:

* Patients \&amp;amp;lt;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.

Primary outcomes:
measure: Selection of DRM to dolutegravir and/or tenofovir and/or lamivudine
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chokwe
country: Mozambique
facility: Hospital Carmelo
Study officials:
References: