- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02354209
Targeted Clinical Strategies and Low Level Viraemia (LLV) in Boosted Protease Inhibitor Therapy
Targeted Clinical Strategies and Low Abundance HIV Viraemia in Boosted-PI Therapy: an Observational Study
Study Overview
Status
Conditions
Detailed Description
Phase of Study: Non-Drug Study
Objectives:
Primary To investigate the causes of low level viraemia (LLV) in HIV-infected individuals with no PI resistance associated mutations (RAMs) on conventional genotyping who have a detectable plasma HIV viral load (pVL) and report >95% adherence* to their ARV regimens containing a boosted protease inhibitor.
*in case the questionnaire cannot be performed, clinical documentation of adherence will be used for interpretation of adherence level.
Secondary To observe the evolution in virologic and immunologic responses following routine clinical intervention in HIV-infected individuals with no primary protease inhibitor mutations (IAS, USA) on conventional genotyping who have a detectable plasma HIV viral load (pVL) and report >95% adherence* to antiretroviral regimens containing a boosted protease inhibitor.
- in case the questionnaire cannot be performed, clinical documentation of adherence will be used for interpretation of adherence level.
Study Design: A multi-centre, non-drug, observational cohort study.
Methodology: HIV-infected individuals attending three selected HIV clinics at the Chelsea and Westminster Hospital, St Mary's Hospital and Guy's and St Thomas' Hospital over the duration of the study will be identified at weekly viral resistance meetings and routine clinic appointments if they demonstrate the following HIV pVL criteria:
- An HIV pVL of 41-2000 copies/ml (c/ml) on two consecutive tests after being <40 c/ml on at least two occasions on a bPI-containing regimen
- An HIV pVL of 41-2000 c/ml on two consecutive tests having never achieved <40 c/ml on a bPI-containing regimen after more than six months of treatment.
Eligible patients will be provided with a patient information sheet and a written consent form. Following consent:
- Virologic and immunologic assessments will be collected from the clinical records available
- Viral resistance test (VRT) (using VircoTYPE HIV-1 Virtual PhenotypeTM-LM for conventional genotyping and Ilumina MiSeq as next generation sequencing, NGS for minority species testing) will be performed on the first detectable HIV pVL(>40 c/mL) found in clinic and at 3 to 6 and 12 months later, if HIV pVL is still >40 c/mL.
Planned Sample Size: 120 to 240 samples over the one-year study period, with each centre providing 40 to 80 samples.
Summary of Eligibility Criteria: HIV-infected individuals with no primary protease inhibitor mutations (IAS, USA) on standard VRTs who have a detectable pVL and report >95% adherence* ARV regimens containing a boosted protease inhibitor with HIV VL criteria as detailed above. Individuals who have a detectable HIV VL after stopping ARV or having an 8-item Morisky score of above 2 (or <95% reported adherence will not be eligible.
*in case the questionnaire cannot be performed, clinical documentation of adherence will be used for interpretation of adherence level.
Number of Study Centres: Three
Duration of Study: One year from study approval. Samples for resistance testing will be collected over the duration of the study.
Criteria for Evaluation:
- Emergence of new primary protease inhibitor mutations (IAS, USA) using NGS will be described.
- Comparison of respective parameters (HIV VL and CD4 count) between different clinical interventions. The latter will not be dictated by the protocol but will be conducted as routine clinical practice.
Primary Endpoint:
Development of primary protease inhibitor mutations (IAS, USA) on NGS in HIV-infected patients with primary protease inhibitor mutations (IAS, USA) on standard VRTs who demonstrate LLV on ARV regimens containing a bPI.
Secondary Endpoints:
- Proportion of patients achieving an undetectable HIV VL following an intervention during periods of LLV on ARV regimens containing a bPI
- Evolution of CD4 cell count following an intervention during periods of LLV on ARV regimens containing a bPI.
Note: This is a non-drug study and no interventions will be dictated by this protocol.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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London, United Kingdom, W2 1NY
- St Mary's Hospital
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London, United Kingdom, SE1 7EH
- St Thomas Hospital
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London, United Kingdom, SW10 9NH
- St Stephen's Centre
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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:
A subject will be eligible for inclusion in the study if ALL of the following criteria apply:
- Chronic HIV-1 infection (adult male, female or transgender)
- Age >18 years
- Current HIV clinic attendee at the Chelsea and Westminster Hospital, St Mary's Hospital, and Guy's and St Thomas' Hospital [defined as at least 1 attended clinic visit since January 2010]
- Receiving a boosted protease inhibitor-containing antiretroviral regimen (bPI ARV)
- HIV plasma viral load (pVL) of 41-2000 copies/ml (c/ml) on two consecutive tests after being <40 c/ml on at least two occasions on a bPI-containing regimen OR HIV pVL of 41-2000 c/ml on two consecutive tests having never achieved <40 c/ml on a bPI containing regimen after more than six months of treatment.
Exclusion Criteria:
A subject will NOT be eligible for inclusion in this clinical trial if the following criteria apply:
- Demonstrable detectable HIV VL after stopping ARV
8-item Morisky score of 2 or more or documented poor adherence to combination ARV. (<95% adherence*)
- in case the questionnaire cannot be performed, clinical documentation of adherence will be used for interpretation of adherence level
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
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HIV-1 patients receiving bPI ARV
Non interventional study. Interventions will be clinically directed rather than by protocol. The following procedures will be carried out:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in primary protease inhibitor mutations on the HIV genome as defined by IAS-USA drug resistance mutations list.
Time Frame: Change between baseline and 12 months after first detectble viral load
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Change between baseline and 12 months after first detectble viral load
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of patients achieving an undetectable HIV VL following an intervention following LLV on ARV regimens containing a bPI
Time Frame: 12 months after first detectable VL on bPI
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12 months after first detectable VL on bPI
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Change in cell count following an intervention during periods of LLV on ARV regimens containing a bPI
Time Frame: Change in CD4 cell count from baseline to 1 year
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Change in CD4 cell count from baseline to 1 year
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marta Boffito, Chelsea & Westminster Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
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
- SSAT 057
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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