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Improving HIV-1 Control in Africa with Long Acting Antiretrovirals

NCT05546242 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 540

Last updated 2024-09-27

No results posted yet for this study

Summary

IMPALA is a randomized, open-label, multicenter, interventional study of 540 virologically suppressed HIV-1 infected adults who have a history of sub-optimal adherence to daily oral ART and/or engagement in HIV care. The study will seek to demonstrate non-inferior antiviral effectiveness of the 2-monthly long-acting injectable combination of cabotegravir/rilpivirine as compared to continuation of first line oral antiretroviral therapy.

Conditions

Interventions

DRUG

Cabotegravir/Rilpivirine

injectable long-acting cabotegravir 600mg + long-acting rilpivirine 900mg administered every 2 months

DRUG

Antiretroviral

Oral antiretroviral therapy in the form of 2NRTIs + dolutegravir 50mg administered daily

Sponsors & Collaborators

  • Janssen Pharmaceuticals

    collaborator INDUSTRY

  • MRC/UVRI and LSHTM Uganda Research Unit

    lead OTHER

Principal Investigators

  • Fiona Cresswell, MBChB, PhD · MRC/UVRI & LSHTM

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-08
Primary Completion
2025-04-30
Completion
2026-03-31

Countries

  • Kenya
  • South Africa
  • Uganda

Study Locations

More Related Trials

Entities

Diseases

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 NCT05546242 on ClinicalTrials.gov