Actively Recruiting
Selection of Resistant Mutations to Dolutegravir and Associated Drugs in People Living with HIV Treated in Clinical Practice in Chokw e9, Mozambique
Led by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia · Updated on 2025-05-15
200
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying people living with HIV in Mozambique to understand if the virus develops resistance to antiretroviral drugs when the infection is not fully controlled despite treatment. This observational study focuses on patients receiving a common first-line treatment called TLD but who still have detectable virus levels. The goal is to see if the virus mutates in ways that make controlling HIV infection more difficult. During one study visit, participants will have a blood sample taken to test for mutations in the HIV virus that might resist antiretroviral drugs. The study uses advanced genetic testing techniques to analyze the virus, including RNA extraction, gene amplification, and sequencing. Along with the blood test, researchers will collect routine clinical and demographic information and record medical history related to HIV infection and treatment. Participants will provide information through a questionnaire during the visit, and their blood samples will be analyzed for drug resistance mutations. The researchers will measure the selection of resistance mutations to dolutegravir and other drugs over three months. The study involves a single visit and includes safety and laboratory assessments but does not involve any changes in treatment. Participation lasts only for this one visit, and results will help understand virus behavior under current treatment conditions.
CONDITIONS
Brief Title
Selection of Resistant Mutations to Dolutegravir in PLWH Treated in Mozambique
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 viral load greater than 200 copies/ml.
You will not qualify if you...
- Patients younger than 18 years of age.
- Under the first line regimen other than TLD.
- Patients with active cancer.
- Patients with active opportunistic diseases.
- Patients unable to give informed consent.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for consent and eligibility assessment
Duration - Single visit
Participants undergo a single study visit during which blood samples are taken to analyze the presence or absence of resistant mutations in the HIV virus, along with collection of clinical and demographic information.
1 visit (in-person) including blood draw and questionnaire
Duration - Up to 3 months
Participants' viral load and resistance to HIV drugs are monitored through routine clinical care following the study visit.
Follow-up visits as per routine clinical care
Trial Site Locations
Total: 1 location
1
Hospital Carmelo
Chokwé, Mozambique, F2C3+JPR
Actively Recruiting
Research Team
D
Daniel Podzamczer, PhD
A
Antonio Navarro, MSc
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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