Identifying HIV Drug Resistance Mutations in Mozambique
Selection of Resistant Mutations to Dolutegravir and Associated Drugs in PLWH Treated in Clinical Practice in Chokwé, Mozambique
This study is trying to see if people with uncontrolled HIV who are on treatment develop changes in the virus that make their medications less effective.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia Academic / other |
| Locations | 1 site (Chokwé) |
| Trial ID | NCT06607588 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate whether patients with uncontrolled HIV infection, despite being on antiretroviral therapy, develop mutations that confer resistance to these treatments. Participants will provide a blood sample for analysis of HIV mutations, alongside demographic and clinical data. The study will focus on patients who have been on the first-line treatment regimen for at least six months and have a viral load above 200 copies/ml. The findings could help understand the relationship between treatment adherence and the emergence of drug resistance.
Who should consider this trial
Good fit: Ideal candidates are adults with documented HIV-1 infection who have been on the first-line TLD regimen for at least six months and have a viral load greater than 200 copies/ml.
Not a fit: Patients under 18 years of age or those with active neoplastic processes or opportunistic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for managing HIV treatment and preventing drug resistance.
How similar studies have performed: Other studies have shown success in identifying drug resistance mutations in HIV, making this approach both relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion 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 \>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.
Where this trial is running
Chokwé
- Hospital Carmelo — Chokwé, Mozambique (Recruiting)
Study contacts
- Study coordinator: Daniel Podzamczer, PhD
- Email: dpodzamczer@gmail.com
- Phone: 0034675335888
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.