HIVNCT02354209
Targeted Clinical Strategies and Low Level Viraemia (LLV) in Boosted Protease Inhibitor Therapy
An observational study of HIV, run by St Stephens Aids Trust at 3 sites in United Kingdom.
Trial summary
The purpose of the study is to look at possible reasons why some HIV positive people who take their drugs properly and have no resistance to these drugs, still have low amounts of virus detectable in their blood. This is known as Low Level Viraemia (LLV). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- How many people
- 50 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Mar 2015to 30 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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)
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
St Thomas Hospital
London, SE1 7EH
St Stephen's Centre
London, SW10 9NH
St Mary's Hospital
London, W2 1NY
About this study
Official title: Targeted Clinical Strategies and Low Abundance HIV Viraemia in Boosted-PI Therapy: an Observational Study
The purpose of the study is to look at possible reasons why some HIV positive people who take their drugs properly and have no resistance to these drugs, still have low amounts of virus detectable in their blood. This is known as Low Level Viraemia (LLV). When low levels of HIV virus are present, some can mutate and make the drugs less effective (i.e. some variants of the virus become more resistant). Currently, however, these resistance mutations may be difficult to detect using standard tests for resistance because the amount of virus in the blood is very low and the standard tests aren't sensitive enough to pick up the mutations. The investigators will use more sensitive mutation detection methods, known as Next Generation Sequencing (NGS), to look at whether see if there are any low levels of drug resistant HIV virus developing in the blood when LLV occurs. The investigators will look at the different treatment strategies that are used in routine standard practice when LLV is detected and evaluate which is most effective in preventing development of resistance. The investigators hope this research will help to inform guidelines on the best way to treat HIV in the future.
Read the 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.
- Conditions
- HIV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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: 1. Questionnaire on compliance and adherence 2. Clinic Visit 3. 20ml blood sample to be taken for Virological Resistance Testing and Next Generation Sequencing (only if plasma viral load is detectable) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in primary protease inhibitor mutations on the HIV genome as defined by IAS-USA drug resistance mutations list.
Measured: Change between baseline and 12 months after first detectble viral load
Secondary outcomes (2)
Proportion of patients achieving an undetectable HIV VL following an intervention following LLV on ARV regimens containing a bPI
Measured: 12 months after first detectable VL on bPI
Change in cell count following an intervention during periods of LLV on ARV regimens containing a bPI
Measured: Change in CD4 cell count from baseline to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2015 (estimated)
- Study startMar 2015
- Primary completion31 Mar 2018
- Study completion30 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- St Stephens Aids Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marta Boffito, Principal investigator, Chelsea & Westminster Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02354209
- Sponsor's protocol ID
- SSAT 057
- Status last verified
- May 2018
- First submitted
- 29 Jan 2015
- Last updated
- 22 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Clinical Strategies and Low Abundance HIV Viraemia in Boosted-PI Therapy: an Observational Study
- ClinicalTrials.gov ID
- NCT02354209
- Acronym / sponsor ID
- SSAT 057
- Conditions
- HIV
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- St Stephens Aids TrustUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 30 Jul 2018 (estimated)
- First posted
- 3 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to look at possible reasons why some HIV positive people who take their drugs properly and have no resistance to these drugs, still have low amounts of virus detectable in their blood. This is known as Low Level Viraemia (LLV). When low levels of HIV virus are present, some can mutate and make the drugs less effective (i.e. some variants of the virus become more resistant). Currently, however, these resistance mutations may be difficult to detect using standard tests for resistance because the amount of virus in the blood is very low and the standard tests aren't sensitive enough to pick up the mutations. The investigators will use more sensitive mutation detection methods, known as Next Generation Sequencing (NGS), to look at whether see if there are any low levels of drug resistant HIV virus developing in the blood when LLV occurs. The investigators will look at the different treatment strategies that are used in routine standard practice when LLV is detected and evaluate which is most effective in preventing development of resistance. The investigators hope this research will help to inform guidelines on the best way to treat HIV in the future.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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: 1. Questionnaire on compliance and adherence 2. Clinic Visit 3. 20ml blood sample to be taken for Virological Resistance Testing and Next Generation Sequencing (only if plasma viral load is detectable) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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)
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (4 listed)
- 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*)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2018.
Related trials for HIV
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marta Boffito principal investigator
Chelsea & Westminster Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by St Stephens Aids Trust at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2018.