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ODYSSEY (PENTA 20)

NCT02259127 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 792

Last updated 2025-07-29

Study results available
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Summary

A new anti-HIV medicine (Dolutegravir) combined with 2 currently used anti-HIV medicines is non-inferior to the standard combination of medicines used in terms of efficacy and better in terms of toxicity.

Conditions

  • HIV Infection

Interventions

DRUG

Dolutegravir

DRUG

Standard of Care

PI or non nucleoside transcriptase inhibitors

Sponsors & Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

    collaborator OTHER_GOV

  • Program for HIV Prevention and Treatment (PHPT)

    collaborator UNKNOWN

  • ViiV Healthcare

    collaborator INDUSTRY

  • MRC CTU at UCL

    collaborator UNKNOWN

  • PENTA Foundation

    lead NETWORK

Principal Investigators

  • Diana Gibb · Medical Research Council Clinical Trials Unit at UCL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
28 Days
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-20
Primary Completion
2021-03-02
Completion
2023-12-07

Countries

  • Germany
  • Portugal
  • South Africa
  • Spain
  • Thailand
  • Uganda
  • United Kingdom
  • Zimbabwe

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 NCT02259127 on ClinicalTrials.gov