Selection of Resistant Mutations to Dolutegravir in PLWH Treated in Mozambique

NCT06607588 | Recruiting

• 1 other identifier: REDOCh study
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV; HIV Antiretroviral Therapy (ART) Adherence

Keywords

HIV; ARV; Resistance; DTG; Africa

Outcome Measures

Primary Outcomes (1)

• Selection of DRM to dolutegravir and/or tenofovir and/or lamivudine

  % of Selection of DRM to dolutegravir and/or tenofovir and/or lamivudine

  3 months

Study Arms (1)

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

Other: Not applicable- observational study

Interventions

Not applicable- observational study OTHER

Not applicable- observational study

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Hospital Carmelo

Chokwé, F2C3+JPR, Mozambique

RECRUITING

Related Links

• Inquérito INSIDA

Central Study Contacts

Daniel Podzamczer, PhD

CONTACT

0034675335888; dpodzamczer@gmail.com

Antonio Navarro, MSc

CONTACT

+0034675335888; anavarro@igtp.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: September 23, 2024
• Study Start: October 25, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

MO (1)