- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02526940
Impact of Pre-ART Blood CD4+ T Cell Level on the Rectal Reservoir in Long-term HIV-1 Treated Men (VIRECT)
Impact of Pre- Antiretroviral Therapy (ART) Blood Cluster of Differentiation (CD)4+ T Cell Level on the Rectal Reservoir in Long-term HIV-1 Treated Men
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Saint-Etienne, France, 42055
- CHU Saint-etienne
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Seropositive for HIV
- Under HAART since at least one and less than 4 years
- No blood HIV RNA rebound during the therapy
- Indication of Human Papilloma Virus (HPV) screening by anal rectoscopy
- Signature of the informed consent form
Exclusion Criteria:
- Patient under tutelage
- No signature of the informed consent form
- No CD4 cell count available at the time of HAART initiation
- One or several viral rebound(s) during therapy
- Coinfection by hepatitis B virus (HBV) or hepatitis C virus (HCV)
- Hemostasis disorders, anticoagulant therapy
- No medical indication of rectoscopy
- Inflammatory bowel disease
- No understanding of the protocol
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
blood CD4 cells count < 200/mm3
patients with blood CD4 cells count at the time of initiation of HAART< 200/mm3. Six rectal biopsies and blood samples collected for each patient treated by HAART more than 1 year and less than 4 years |
Blood samples
6 rectal biopsies
|
blood CD4 cells count : 200 - 300/mm3
patients with blood CD4 cells count at the time of initiation of HAART between 200 and 300/mm3 Six rectal biopsies and blood samples collected for each patient treated by HAART more than 1 year and less than 4 years
|
Blood samples
6 rectal biopsies
|
blood CD4 cells count >350/mm3
patients with blood CD4 cells count at the time of initiation of HAART> 350/mm3. Six rectal biopsies and blood samples collected for each patient treated by HAART more than 1 year and less than 4 years |
Blood samples
6 rectal biopsies
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HIV DNA load in rectal biopsies
Time Frame: day 1
|
Comparison of HIV DNA load (copies/106 cells) in rectal biopsies between 3 groups of patients (10 per group) according to their blood CD4 cells count at the time of initiation of Highly Active Antiretroviral Therapy (HAART) : <200, 200-300 and >350/mm3
|
day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HIV DNA load in blood peripheral blood mononuclear cell (PBMC)
Time Frame: Day 1
|
Comparison of HIV DNA load (copies/106 cells) in blood PBMC between 3 groups of patients (10 per group) according to their blood CD4 cells count at the time of initiation of HAART : <200, 200-300 and >350/mm3
|
Day 1
|
HIV RNA load in blood PBMC
Time Frame: Day 1
|
Comparison of HIV RNA load (copies/106 cells) in blood PBMC between 3 groups of patients (10 per group) according to their blood CD4 cells count at the time of initiation of HAART : <200, 200-300 and >350/mm3
|
Day 1
|
HIV RNA load in rectal biopsies
Time Frame: Day 1
|
Comparison of HIV RNA load (copies/106 cells) in rectal biopsies between 3 groups of patients (10 per group) according to their blood CD4 cells count at the time of initiation of HAART : <200, 200-300 and >350/mm3
|
Day 1
|
Cellular composition in rectal biopsies
Time Frame: Day 1
|
Comparison of Cellular composition in rectal biopsies between 3 groups of patients (10 per group) according to their blood CD4 cells count at the time of initiation of HAART : <200, 200-300 and >350/mm3. Cellular composition is a outcome measure : expression of CD3, CD4, CD8, CD27, CD45, CCR5 by flow cytometry |
Day 1
|
Cellular composition in blood PBMC
Time Frame: Day 1
|
Comparison of Cellular composition in blood PBMCbetween 3 groups of patients (10 per group) according to their blood CD4 cells count at the time of initiation of HAART : <200, 200-300 and >350/mm3. Cellular composition is a outcome measure : expression of CD3, CD4, CD8, CD27, CD45, CCR5 by flow cytometry |
Day 1
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
- Immunologic Deficiency Syndromes
Other Study ID Numbers
- 1308020
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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