NCT05312918

Brief Summary

Main objective The main objective of the study is to assess the virological efficacy of a Dolutegravir-based first-line ART in use under real-life conditions in national programs in resource-limited settings in patients infected with HIV-1 and initially under a NNRTI-based first-line, and determine the impact of NRTI resistance on the success of the new strategy. Secondary objectives

  • Determine the level of virological suppression (HIV-1 RNA \<200 copies/ml) at 6, 12 and 24 months after transition from an NNRTI first-line to a DTG first-line.
  • Determine the level of virological suppression at the WHO threshold (HIV-1 RNA \<1000 copies/ml).
  • To determine the frequency of development of resistance and the profiles of mutations in patients with virological failure (HIV-1 RNA ≥200 copies/ml) and the potential impact on the 2nd line strategies combining DTG and currently recommended by the WHO.
  • To determine the impact of pre-transition resistance to NRTIs on the virological suppression under DTG first-line and on the development of resistance to integrase inhibitors.
  • Study pre-transition resistance acquired under DTG first-lines at the thresholds of 20% and 5% of the viral population, respectively using Sanger and Ultra-deep Sequencing (UDS) approaches. Identify program factors associated with virological failure and/or the development of drug resistance.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
603

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2022

Typical duration for all trials

Geographic Reach
3 countries

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2021

Completed
7 months until next milestone

First Posted

Study publicly available on registry

April 6, 2022

Completed
25 days until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

April 6, 2022

Status Verified

March 1, 2022

Enrollment Period

10 months

First QC Date

September 22, 2021

Last Update Submit

March 28, 2022

Conditions

HIV Infections

Keywords

HIV InfectionsDolutegravirHIV drug resistanceReal Life

Outcome Measures

Primary Outcomes (1)

  • Proportion virological success

    Proportion of patients with virological success at Week 48 (Month 12), defined by a VL \<200 copies/ml.

    48 weeks

Secondary Outcomes (31)

  • Virological suppression at W24 (VL< 200 copies/ml)

    24 weeks

  • Virological suppression at W96 (VL< 200 copies/ml)

    96 weeks

  • Virological suppression at VL thresholds of 200 copies/ml, considering the first point of viral load and the control viral load if the first point of viral load was >200 copies/ml.

    36 weeks

  • Virological suppression at VL thresholds of 200 copies/ml, considering the first point of viral load and the control viral load if the first point of viral load was >200 copies/ml.

    60 weeks

  • Virological suppression at VL thresholds of 200 copies/ml, considering the first point of viral load and the control viral load if the first point of viral load was >200 copies/ml.

    108 weeks

  • +26 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

HIV-1 infected individuals who are transitioning from an NNRTI-based first-line to a Dolutegravir-based first-line treatment.

You may qualify if:

  • Aged 18 years or over.
  • Infected with HIV-1.
  • On an NNRTI-based first-line for at least 6 months.
  • Initiating a new 1st line ART based on DTG according to national recommendations.
  • Agree to participate in the study and provide free, written and informed consent.

You may not qualify if:

  • Infection with HIV-2 or HIV1+2.
  • Ongoing participation in another virological study on HIV infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CIRBA

Abidjan, Côte d’Ivoire

Location

SEREFO

Bamako, Mali

Location

Biolim/Fss/Ul

Lomé, Togo

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood samples will be collected for this study and will be used for viral load testing and drug resistance evaluation.

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Avelin AGHOKENG

    IRD 224 - CNRS 5290 - UM1-UM2

    STUDY DIRECTOR

  • Anoumou Claver DAGNRA

    BIOLIM - FSS - UL

    STUDY DIRECTOR

Central Study Contacts

Avelin AGHOKENG

CONTACT

04 67 41 59 58avelin.aghokeng@ird.fr

Anoumou Claver DAGNRA

CONTACT

228 900 156 56claverdagnra@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2021

First Posted

April 6, 2022

Study Start

May 1, 2022

Primary Completion

March 1, 2023

Study Completion

October 1, 2024

Last Updated

April 6, 2022

Record last verified: 2022-03

Locations

MA(1)CÔ(1)TO(1)