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Nucleosides And Darunavir/Dolutegravir In Africa

NCT03988452 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 465

Last updated 2020-07-30

No results posted yet for this study

Summary

This trial evaluates options for second-line antiretroviral therapy in patients failing on a non-nucleoside reverse transcriptase inhibitor (NNRTI) and tenofovir (TDF)-based first-line regimen in the setting of the public health approach in sub-Saharan Africa (with assumed substantial nucleoside reverse transcriptase inhibitor (NRTI) cross-resistance). The trial tests two hypotheses. Firstly that a regimen of dolutegravir (DTG) with two NRTIs is non-inferior to a regimen of ritonavir-boosted darunavir (DRV/r) with two NRTIs. Secondly that continuing an NRTI regimen of TDF and lamivudine (3TC) is non-inferior to switching to zidovudine (ZDV) and 3TC.

The trial is a parallel group, open-label, multi-centre, factorial (2X2) randomised, controlled trial. Patients will be randomised to either DTG or DRV/r with a second randomisation to ZDV and 3TC or TDF and 3TC. Treatment efficacy will be monitored by testing viral load (VL). Analyses will compare DRV/r with DTG; and ZDV/3TC with TDF/3TC by intention to treat analysis on the primary outcome parameter of plasma VL below 400 copies/ml at 48 weeks. Trial follow-up will continue to 96 weeks.

Conditions

  • Human Immunodeficiency Virus

Interventions

DRUG

Darunavir

Antiretroviral therapy

DRUG

Ritonavir

Antiretroviral therapy

DRUG

Dolutegravir

Antiretroviral therapy

DRUG

Zidovudine

Antiretroviral therapy

DRUG

Tenofovir

Antiretroviral therapy

DRUG

Lamivudine

Antiretroviral therapy

Sponsors & Collaborators

  • Infectious Diseases Institute, Uganda

    collaborator OTHER

  • Makerere University

    lead OTHER

Principal Investigators

  • Nicholas Paton, MD · National University of Singapore

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-30
Primary Completion
2020-09-30
Completion
2021-09-30

Countries

  • Uganda

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03988452 on ClinicalTrials.gov