- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05312918
Large Scale Transition to a Dolutegravir-based First-line ART in the South: Virological Response and Impact on HIV Drug Resistance in a Real Life Context (DoReaL Study)
Main objective The main objective of the study is to assess the virological efficacy of a Dolutegravir-based first-line ART in use under real-life conditions in national programs in resource-limited settings in patients infected with HIV-1 and initially under a NNRTI-based first-line, and determine the impact of NRTI resistance on the success of the new strategy.
Secondary objectives
- Determine the level of virological suppression (HIV-1 RNA <200 copies/ml) at 6, 12 and 24 months after transition from an NNRTI first-line to a DTG first-line.
- Determine the level of virological suppression at the WHO threshold (HIV-1 RNA <1000 copies/ml).
- To determine the frequency of development of resistance and the profiles of mutations in patients with virological failure (HIV-1 RNA ≥200 copies/ml) and the potential impact on the 2nd line strategies combining DTG and currently recommended by the WHO.
- To determine the impact of pre-transition resistance to NRTIs on the virological suppression under DTG first-line and on the development of resistance to integrase inhibitors.
- Study pre-transition resistance acquired under DTG first-lines at the thresholds of 20% and 5% of the viral population, respectively using Sanger and Ultra-deep Sequencing (UDS) approaches.
Identify program factors associated with virological failure and/or the development of drug resistance.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Avelin AGHOKENG
- Phone Number: 04 67 41 59 58
- Email: avelin.aghokeng@ird.fr
Study Contact Backup
- Name: Anoumou Claver DAGNRA
- Phone Number: 228 900 156 56
- Email: claverdagnra@gmail.com
Study Locations
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Abidjan, Côte D'Ivoire
- CIRBA
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Contact:
- Thomas d'Aquin TONI
- Phone Number: 225 05 89 81 49
- Email: tonithomasd@gmail.com
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Bamako, Mali
- SEREFO
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Contact:
- Almoustapha MIAGA
- Email: amaiga@icermali.org
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Lomé, Togo
- Biolim/Fss/Ul
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Contact:
- Anoumou Claver DAGNRA
- Phone Number: 228 900 156 56
- Email: claverdagnra@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Aged 18 years or over.
- Infected with HIV-1.
- On an NNRTI-based first-line for at least 6 months.
- Initiating a new 1st line ART based on DTG according to national recommendations.
- Agree to participate in the study and provide free, written and informed consent.
Exclusion Criteria:
- Infection with HIV-2 or HIV1+2.
- Ongoing participation in another virological study on HIV infection
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion virological success
Time Frame: 48 weeks
|
Proportion of patients with virological success at Week 48 (Month 12), defined by a VL <200 copies/ml.
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48 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Virological suppression at W24 (VL< 200 copies/ml)
Time Frame: 24 weeks
|
Proportion of patients with virological suppression at W24 (VL< 200 copies/ml).
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24 weeks
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Virological suppression at W96 (VL< 200 copies/ml)
Time Frame: 96 weeks
|
Proportion of patients with virological suppression at W96 (VL< 200 copies/ml).
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96 weeks
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Virological suppression at VL thresholds of 200 copies/ml, considering the first point of viral load and the control viral load if the first point of viral load was >200 copies/ml.
Time Frame: 36 weeks
|
Proportion of patients with virological suppression at VL thresholds of 200 copies/ml, considering the first point of viral load at W24 and the control viral load at W36 if the first point of viral load was >200 copies/ml.
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36 weeks
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Virological suppression at VL thresholds of 200 copies/ml, considering the first point of viral load and the control viral load if the first point of viral load was >200 copies/ml.
Time Frame: 60 weeks
|
Proportion of patients with virological suppression at VL thresholds of 200 copies/ml, considering the first point of viral load at W48, and the control viral load at W60 if the first point of viral load was >200 copies/ml.
|
60 weeks
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Virological suppression at VL thresholds of 200 copies/ml, considering the first point of viral load and the control viral load if the first point of viral load was >200 copies/ml.
Time Frame: 108 weeks
|
Proportion of patients with virological suppression at VL thresholds of 200 copies/ml, considering the first point of viral load at W96, and the control viral load at W108 if the first point of viral load was >200 copies/ml.
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108 weeks
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Virological suppression at the WHO threshold (< 1000 copies/ml).
Time Frame: 24 weeks
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Proportion of patients with virological suppression at the WHO threshold at W24 (< 1000 copies/ml).
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24 weeks
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Virological suppression at the WHO threshold (< 1000 copies/ml).
Time Frame: 48 weeks
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Proportion of patients with virological suppression at the WHO threshold at W48 (< 1000 copies/ml).
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48 weeks
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Virological suppression at the WHO threshold (< 1000 copies/ml).
Time Frame: 96 weeks
|
Proportion of patients with virological suppression at the WHO threshold at W96 (< 1000 copies/ml).
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96 weeks
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Virological suppression at VL thresholds of 1000 copies/ml, considering the first point of viral load, and the control viral load if the first point of viral load was >1000 copies/ml.
Time Frame: 36 weeks
|
Proportion of patients with virological suppression at VL thresholds of 1000 copies/ml, considering the first point of viral load at W24, and the control viral load at W36 if the first point of viral load was >1000 copies/ml.
|
36 weeks
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Virological suppression at VL thresholds of 1000 copies/ml, considering the first point of viral load, and the control viral load if the first point of viral load was >1000 copies/ml.
Time Frame: 60 weeks
|
Proportion of patients with virological suppression at VL thresholds of 1000 copies/ml, considering the first point of viral load at W48, and the control viral load at W60 if the first point of viral load was >1000 copies/ml.
|
60 weeks
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Virological suppression at VL thresholds of 1000 copies/ml, considering the first point of viral load, and the control viral load if the first point of viral load was >1000 copies/ml.
Time Frame: 108 weeks
|
Proportion of patients with virological suppression at VL thresholds of 1000 copies/ml, considering the first point of viral load at W96, and the control viral load at W108 if the first point of viral load was >1000 copies/ml.
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108 weeks
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Virological suppression at the optimal threshold (<50 copies/ml)
Time Frame: 24 weeks
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Proportion of patients with virological suppression at the optimal threshold at W24 (<50 copies/ml)
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24 weeks
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Virological suppression at the optimal threshold (<50 copies/ml)
Time Frame: 48 weeks
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Proportion of patients with virological suppression at the optimal threshold at W48 (<50 copies/ml)
|
48 weeks
|
Virological suppression at the optimal threshold (<50 copies/ml)
Time Frame: 96 weeks
|
Proportion of patients with virological suppression at the optimal threshold at W96 (<50 copies/ml)
|
96 weeks
|
Virological suppression at VL thresholds of 50 copies/ml, considering the first point of viral load, and the control viral load if the first point of viral load was >50 copies/ml.
Time Frame: 36 weeks
|
Proportion of patients with virological suppression at VL thresholds of 50 copies/ml, considering the first point of viral load at W24, and the control viral load at W36 if the first point of viral load was >50 copies/ml.
|
36 weeks
|
Virological suppression at VL thresholds of 50 copies/ml, considering the first point of viral load, and the control viral load if the first point of viral load was >50 copies/ml.
Time Frame: 60 weeks
|
Proportion of patients with virological suppression at VL thresholds of 50 copies/ml, considering the first point of viral load at W48, and the control viral load at W60 if the first point of viral load was >50 copies/ml.
|
60 weeks
|
Virological suppression at VL thresholds of 50 copies/ml, considering the first point of viral load, and the control viral load if the first point of viral load was >50 copies/ml.
Time Frame: 108 weeks
|
Proportion of patients with virological suppression at VL thresholds of 50 copies/ml, considering the first point of viral load at W96, and the control viral load at W108 if the first point of viral load was >50 copies/ml.
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108 weeks
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Proportion of patients with virological suppression at VL thresholds of 50, 200 copies/ml and 1000 copies/ml, depending on the viral load at the time of switch
Time Frame: 24 weeks
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Proportion of patients with virological suppression at VL thresholds of 50, 200 copies/ml and 1000 copies/ml, at W24, depending on the viral load at the time of switch according to 3 groups (VL of D0 <200 copies/ml, between 200 and 1000 copies/ml, and ≥1000 copies/ml)
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24 weeks
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Proportion of patients with virological suppression at VL thresholds of 50, 200 copies/ml and 1000 copies/ml, depending on the viral load at the time of switch
Time Frame: 48 weeks
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Proportion of patients with virological suppression at VL thresholds of 50, 200 copies/ml and 1000 copies/ml, at W48, depending on the viral load at the time of switch according to 3 groups (VL of D0 <200 copies/ml, between 200 and 1000 copies/ml, and ≥1000 copies/ml)
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48 weeks
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Proportion of patients with virological suppression at VL thresholds of 50, 200 copies/ml and 1000 copies/ml, depending on the viral load at the time of switch
Time Frame: 96 weeks
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Proportion of patients with virological suppression at VL thresholds of 50, 200 copies/ml and 1000 copies/ml, at W96, depending on the viral load at the time of switch according to 3 groups (VL of D0 <200 copies/ml, between 200 and 1000 copies/ml, and ≥1000 copies/ml)
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96 weeks
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Frequency of drug resistance
Time Frame: 24 weeks
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Frequency of resistance mutations acquired at confirmed virological failure, at VL thresholds of 200 copies/ml and 1000 copies/ml.
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24 weeks
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Profiles of resistance mutations
Time Frame: 24 weeks
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Profiles of resistance mutations acquired at confirmed virological failure, at VL thresholds of 200 copies/ml and 1000 copies/ml.
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24 weeks
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Frequency of drug resistance
Time Frame: 48 weeks
|
Frequency of resistance mutations acquired at confirmed virological failure, at VL thresholds of 200 copies/ml and 1000 copies/ml.
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48 weeks
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Profiles of resistance mutations
Time Frame: 48 weeks
|
Profiles of resistance mutations acquired at confirmed virological failure, at VL thresholds of 200 copies/ml and 1000 copies/ml.
|
48 weeks
|
Frequency of drug resistance
Time Frame: 96 weeks
|
Frequency of resistance mutations acquired at confirmed virological failure, at VL thresholds of 200 copies/ml and 1000 copies/ml.
|
96 weeks
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Profiles of resistance mutations
Time Frame: 96 weeks
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Profiles of resistance mutations acquired at confirmed virological failure, at VL thresholds of 200 copies/ml and 1000 copies/ml.
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96 weeks
|
GSS (Genotypic susceptibility score)
Time Frame: 24 weeks
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Proportion of patients with a GSS ≤1 at W24
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24 weeks
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GSS (Genotypic susceptibility score)
Time Frame: 48 weeks
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Proportion of patients with a GSS ≤1 at W48
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48 weeks
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GSS (Genotypic susceptibility score)
Time Frame: 96 weeks
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Proportion of patients with a GSS ≤1 at W96.
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96 weeks
|
Frequency of pre-transition resistance mutations to NRTIs
Time Frame: At baseline, before DTG initiation
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Frequency of pre-transition resistance mutations to NRTIs
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At baseline, before DTG initiation
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Proportion of HIV minority variants
Time Frame: Up to 108 weeks.
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Proportion of minority variants (5% threshold) in patients with resistance mutations to NRTIs and/or DTG in the event of virological failure.
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Up to 108 weeks.
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Collaborators and Investigators
Investigators
- Study Director: Avelin AGHOKENG, IRD 224 - CNRS 5290 - UM1-UM2
- Study Director: Anoumou Claver DAGNRA, BIOLIM - FSS - UL
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ANRS 12427 DoReaL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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