Targeted Clinical Strategies and Low Level Viraemia (LLV) in Boosted Protease Inhibitor Therapy

NCT02354209 | Unknown

• 1 other identifier: SSAT 057
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 3

Brief 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). 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.

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

• Change in primary protease inhibitor mutations on the HIV genome as defined by IAS-USA drug resistance mutations list.

  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

  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

  Change in CD4 cell count from baseline to 1 year

Study Arms (1)

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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)

You may qualify if:

• 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.

You may not qualify if:

• Demonstrable detectable HIV VL after stopping ARV
• 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

Sponsors & Collaborators

• St Stephens Aids Trust: lead

Study Sites (3)

St Thomas Hospital

London, SE1 7EH, United Kingdom

Location

St Stephen's Centre

London, SW10 9NH, United Kingdom

Location

St Mary's Hospital

London, W2 1NY, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma samples

Study Officials

• Marta Boffito

  Chelsea & Westminster Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2015
• First Posted: February 3, 2015
• Study Start: March 1, 2015
• Primary Completion: March 31, 2018
• Study Completion: July 30, 2018
• Last Updated: May 22, 2018

Record last verified: 2018-05

Locations

GB (3)