ClinicalTrials.gg
RecruitingNCT06607588REDOCHUpdated May 15, 2025

Selection of Resistant Mutations to Dolutegravir in PLWH Treated in Mozambique

An observational study in HIV and HIV Antiretroviral Therapy (ART) Adherence, sponsored by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia. Recruiting at 1 site in Mozambique. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-15.

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

From the registry’s dates

  • Primary completion was expected by Apr 2026, 7 months ago, but the record still lists the study as recruiting.
  • Started Oct 2024; still recruiting 2 years later.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • HIV
  • HIV Antiretroviral Therapy (ART) Adherence

Keywords

  • HIV
  • ARV
  • Resistance
  • DTG
  • Africa
03

In context

Lead sponsor

Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia is the lead sponsor of 45 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients able to understand and sign the form.
  • Documented -1 infection.
  • Under the TLD for at least 6 months.
  • At least 3 months follow-up with CV \>200c/ml.

Exclusion criteria

Exclusion Criteria:

  • Patients \<18 years of age.
  • Under the regime other than TLD.
  • Patients with active neoplastic processes.
  • Patients with active opportunistic diseases.
  • Patients unable to give .
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
200 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

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

    Other: Not applicable- observational study

Interventions

  • OtherNot applicable- observational study

    Not applicable- observational study

06

What researchers measure

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

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
  • Hospital Carmelo
    Chokwe, F2C3+JPR, Mozambique
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2024 (actual). Primary completion is estimated for Apr 2026, 18 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 17, 2024
First posted
Sep 23, 2024
StartActual
Oct 25, 2024
Primary completionEst.
Apr 2026
CompletionEst.
Sep 2026
Last update
May 15, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06607588
Lead sponsor
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Responsible party
Sponsor
First posted
Sep 23, 2024
Start date
Oct 25, 2024
Primary completion
Apr 2026 (estimated)
Completion
Sep 2026 (estimated)
Last update
May 15, 2025

Study contacts

Daniel Podzamczer, PhD
Contact
dpodzamczer@gmail.com
0034675335888
Antonio Navarro, MSc
Contact
anavarro@igtp.cat
+0034675335888

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Discussion

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