NCT04612452

Brief Summary

This is a prospective observational cohort study of 2820 patients on first-line ART switching to a DTG-based first-line regimen, according to the standard of care. The study is conducted in Malawi and Zambia, in ART programs that participate in the IeDEA collaboration. Sequencing will be done on blood samples of patients with a viral load above 400 copies/mL to identify mutations.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
2,820

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Typical duration for all trials

Geographic Reach
2 countries

2 active sites

Status
completed

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

Study Start

First participant enrolled

November 5, 2019

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 3, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2023

Completed
Last Updated

March 24, 2023

Status Verified

March 1, 2023

Enrollment Period

3.4 years

First QC Date

October 27, 2020

Last Update Submit

March 23, 2023

Conditions

HivDrug ResistancyVirologic Failure

Keywords

HivDrug resistancyVirologic failureDTG-based regimenDrug resistance mutations

Outcome Measures

Primary Outcomes (1)

  • The proportion of patients with VF at 48 weeks between patients with and without VF at baseline.

    48 weeks

Secondary Outcomes (10)

  • The proportion of patients with VF at 96 weeks between patients with and without VF at baseline.

    96 weeks

  • The incidence of TLD drug resistances at 48 and 96 weeks in patients with and without VF at switch.

    48 and 96 weeks

  • The proportion of HIV-infected patients with VF at baseline.

    Baseline

  • The proportion of patients with VF at 48 weeks and 96 weeks in patients with VF at baseline who have at least one or no fully active NRTI on resistance testing.

    48 and 96 weeks

  • Prevalence of neuropsychiatric symptoms at baseline, 48 weeks and 96 weeks.

    48 and 96 weeks

  • +5 more secondary outcomes

Study Arms (2)

Lighthouse Trust in Lilongwe

CIDRZ in Lusaka

Eligibility Criteria

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

People living with HIV.

You may qualify if:

  • Patients
  • On first-line ART for 6 months or longer
  • Switching to any DTG-based treatment

You may not qualify if:

  • No informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Lighthouse Trust

Lilongwe, Malawi

Location

CIDRZ

Lusaka, Zambia

Location

Related Publications (1)

  • Skrivankova VW, Huwa J, Muula G, Chiwaya GD, Banda E, Buleya S, Chihota B, Chintedza J, Bolton C, Tweya H, Kalua T, Hossmann S, Kouyos R, Wandeler G, Egger M, Lessells RJ. Virologic Failure and Drug Resistance After Programmatic Switching to Dolutegravir-based First-line Antiretroviral Therapy in Malawi and Zambia. Clin Infect Dis. 2025 Feb 5;80(1):120-128. doi: 10.1093/cid/ciae261.

    PMID: 38847281DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

  • Matthias Egger, Prof.

    University of Berne

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

October 27, 2020

First Posted

November 3, 2020

Study Start

November 5, 2019

Primary Completion

March 22, 2023

Study Completion

March 22, 2023

Last Updated

March 24, 2023

Record last verified: 2023-03

Locations

ZA(1)MA(1)