HIV Specimen Collection Study
Research type
Research Study
Full title
Collection of Specimens from Suppressed HIV Infected Subjects on Antiretroviral Therapy for Biomarker Development
IRAS ID
245489
Contact name
Marta Boffito
Contact email
Sponsor organisation
Merck Sharp & Dohme Limited
Eudract number
2017-003711-19
Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
Human immunodeficiency virus type 1 (HIV-1) infection is an autoimmune disease associated with substantial complications and mortality. Treatment of HIV-1 infection has improved significantly in recent years and can suppress infection enough to allow control of the effects of HIV. Because treatment does not cure HIV infection, people with HIV infection need to receive life-long antiretroviral therapy (ART), which has been highly successful in suppressing the number of HIV viruses in the bloodstream (viral loads) and dramatically improving survival and quality of life.
However, when ART is withdrawn, viral loads rebound to levels before starting ART in over half of patients within 4 weeks (and over 90% of patients within 3 months). The HIV reservoir, a group of immune cells infected and replicating to produce more virus, is the source of on-going circulating viremia (presence of virus in the blood).
The HIV reservoir and viral rebound, which occurs in the absence of therapy is not entirely understood. To further understand this, biomarkers (substances caused by the HIV infection) need to be measured to detect viremia. The aim of this study is to enhance ART, which will target further reduction of residual viremia below that achievable with standard ART.
Approximately 24 participants (aged 18-65 years inclusive) will be enrolled in this unblinded, open label study intended to collect whole blood and rectal tissue samples from HIV-1 infected participants. Study participants will need to be currently taking stable ART with suppressed viral loads (<50 copies/mL) for at least the last 6 months to be enrolled. The study will analyse whole blood and rectal samples for HIV virus concentrations and analyse these tissues for cell associated biomarkers and drug concentrations.
The study is funded by Merck Sharp & Dohme Limited and will take place at one study centre in the UK.
REC name
London - Chelsea Research Ethics Committee
REC reference
18/LO/0735
Date of REC Opinion
12 Jul 2018
REC opinion
Further Information Favourable Opinion