CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 72 target
Drug / intervention
Investigational Medicinal Productdrug
Likely dose
Not stated in record
Key inclusion· 15
  • ✓Aged 18 to 60 years old at screening
  • ✓Able to give informed written consent including consent to long-term follow-up
  • ✓Willing and able to comply with visit schedule and blood sampling
  • ✓Started ART within 6 months of primary infection by one of six documented methods
Key exclusion· 21
  • ✕Previous ischemic heart disease (MI, stroke, angina)
  • ✕Any current or past history of malignancy, excluding squamous cell skin cancers
  • ✕Concurrent opportunistic infection or other comorbidity likely during trial
  • ✕Any contraindication to BHIVA recommended combination antiretrovirals

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04319367
NCT04319367Phase 2RecruitingOn TrackUpdated 26mo ago
Long Recruiting
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A Randomised Placebo Controlled Trial of ART Plus Dual Long-acting HIV-specific Broadly Neutralising Antibodies (bNAbs) vs ART Plus Placebo in Treated Primary or Early Stage HIV Infection on Viral Control Off ART

Imperial College London·interventional·Posted Mar 24, 2020·Updated Apr 17, 2024

In Brief

A Phase 2 clinical trial evaluating Investigational Medicinal Product for HIV/AIDS and Infections. Currently recruiting, targeting 72 participants across 12 sites in 2 countries.

Detailed Summary

RIO is a placebo-controlled double-blinded two arm prospective phase II randomised controlled trial . This study will test the use of broadly neutralising antibodies (bNAbs) in participants with treated primary HIV infection (PHI).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV/AIDS and Infections
CountriesDenmark, United Kingdom
CollaboratorsBill and Melinda Gates Foundation, University of Oxford, Rockefeller University

Timeline

Phase 2Recruiting
2021202220232024202520262027
First PostedMar 24, 2020
Enrollment StartMay 17, 2021
Primary CompletionJul 31, 2027
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 6.3 years agoPrimary completion in 1.1 years

Interventions

Investigational Medicinal Productdrug

Recombinant human monoclonal antibody (mAb) or placebo