Primary objectivesLongitudinal quantification of the total latent HIV reservoir with determination of the size of the replication competent HIV reservoir and investigate potential biomarkers of the HIV reservoir size and nature.Cross compare the…
ID
Source
Brief title
Condition
- Immunodeficiency syndromes
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Quantify the size of the reservoir and explore potential biomarkers of the size
and nature of the reservoir.
Secondary outcome
Correlate study findings to other known biomarkers (from other research
groups).
Background summary
c-ART blocks intracellular HIV-1 replication in CD4+ T-lymphocytes, but fails
to eliminate latent HIV-1 infected CD4+ T-lymphocytes. About 7 in 106 of these
cells are latently infected and can cause reactivation when c-ART is stopped.
For accurate assessment of the impact of potential latency reversing agents
(LRA) on the reservoir, a large reservoir is desirable. The biomarkers that are
correlated with large circulating latent reservoirs are not well characterised.
The purpose of this study is to quantify the reservoir and explore potential
biomarkers of the HIV reservoir size.
Study objective
Primary objectives
Longitudinal quantification of the total latent HIV reservoir with
determination of the size of the replication competent HIV reservoir and
investigate potential biomarkers of the HIV reservoir size and nature.
Cross compare the outcomes of Erasmus and Merck Research Laboratory (MRL)
quantitative HIV latency assays.
Secondary objectives
Assessment of T-cell subsets and explore correlation with reservoir size in
peripheral blood.
Correlate study findings to known data on biomarkers of the HIV reservoir.
Study design
In vitro observational study.
Study burden and risks
Participation involves visiting the research OPD for blood sampling at
enrolment. Follow up blood sampling will be done during routine visits at their
HIV physicians. Blood sampling is by standard phlebotomy, which is a very safe
procedure. The amount of blood drawn is one fifth of a standard blood donation
at the blood bank.
'sGravendijkwal 230
Rotterdam 3011PL
NL
'sGravendijkwal 230
Rotterdam 3011PL
NL
Listed location countries
Age
Inclusion criteria
1. Age >18 years.
2. Confirmed HIV-1 infection.
3. Plasma HIV RNA viral load <50 copies per mL.
4. Taking cART
Exclusion criteria
1 Anemia, defined as a hemoglobin level of <6.0 mmol/L (women) or <6.5 mmol/L (men).
2 Any other condition that, at the discretion of the investigators, prevents proper informed consent procedure and study participation. This include patients with active and disabling substance use or severe psychiatric disorders.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL56568.078.16 |