NCT04208711

Brief Summary

The main objective of this study is to qualify and quantify, by microscopy techniques, CD4+ lymphocyte abnormalities during HIV infection in 7 patients who are naive to any ARV (antiretroviral ) treatment and secondarily to follow the kinetics of reversion of the observed abnormalities, as well as the evolution of the levels of PLA2G1B and its cofactor gp41 in 8 patients under ARV treatment

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable hiv-infections

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable hiv-infections

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2019

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 23, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

February 8, 2021

Status Verified

February 1, 2021

Enrollment Period

3 years

First QC Date

December 2, 2019

Last Update Submit

February 3, 2021

Conditions

HIV Infections

Keywords

HIV infectionPLA2G1BLymphocyte CD4+

Outcome Measures

Primary Outcomes (1)

  • immunological : to qualify and quantify by confocal microscopic techniques and flow cytometry lymphocyte abnormalities

    The assessment of the change in the proportion of lymphocytes at 1, 3, 6, 9 and 12 months as compared to Day 1: * CD4 with membranes abnormalities above normal, * CD4 with major membrane abnormalities, * CD4 with signal transduction abnormalities, * CD4 reversing one of these abnormalities spontaneously or after treatment with neutralizing monoclonal antibody (mAb) 2B2

    up to 1 year

Secondary Outcomes (1)

  • immunological

    up to 1 year

Study Arms (1)

positive HIV patient not treated by ARV yet

OTHER

Before starting HIV treatment, 15 patients will be included in the study and 50mL of whole blood will be taken. After treatment initiation 8 of the 15 patients will entered in the follow-up phase for 1 year (5 followup visit, M1, M3, M6, M9, M12) and 30mL of whole blood will be taken at each visit. The duration of the study for the 7 other patients will be 1 day.

Other: biological sample

Interventions

biological sampleOTHER

whole blood sample

positive HIV patient not treated by ARV yet

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participant aged 18 to under 70
  • Participant having signed the written and informed consent;
  • Patient with HIV-1 infection documented by a positive HIV western blot positive (infected patients\> 6 months, CD4 count\> 350 / mm3 and HIV RNA \<100.000 copies / mL) naive to any ARV treatment Anti-HIV antibody positive and an optical density \<1.0, as determined by enzyme immunoassay, with no significant risk of clinical events
  • Appropriate laboratory data: hemoglobin\> 9 g / dL, absolute neutrophil count ≥1000 / μL, platelets ≥50,000 / μL, bilirubin ≤ 1.5 X upper limit of normal (ULN) or ≤3 X ULN serum creatinine ≤ 1.5 X ULN, alanine amino transferase (ALT) or aspartate amino transferase (AST) ≤ 3 X ULN;
  • ECOG (Eastern Cooperative Oncology Group) performance status scale ≤2
  • Subject benefiting from a French social security scheme, or affiliated to such a scheme

You may not qualify if:

  • History of inflammatory disease such as rheumatoid arthritis, lupus, Crohn's disease, ulcerative colitis
  • A stem cell transplant.
  • History of other malignancies in the last three years except Kaposi controlled.
  • Infection known by hepatitis C or B virus (HCV or HBV)
  • Congestive heart failure, class III or IV, according to the criteria of the New York Heart Association (NYHA).
  • Vulnerable population (minors, pregnant, parturient or nursing women, persons under guardianship or trusteeship, or deprived of liberty by a judicial or administrative decision, under the protection of justice)
  • Patients with dementia or altered mental states who would not understand and provide an informed consent document

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CIC 1417 Cochin Pasteur, hôpital Cochin

Paris, 75014, France

RECRUITING

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Odile LAUNAY, MD, PHD

    CIC 1417 Clinical Center Investigation - Cochin Hospital, AP-HP

    PRINCIPAL INVESTIGATOR

Central Study Contacts

THEZE

CONTACT

+33(0) 1 45 68 86 00jacques.theze@diaccurate.com

DELIGNE

CONTACT

+33(0)1 44 38 93 93claire.deligne@diaccurate.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2019

First Posted

December 23, 2019

Study Start

March 1, 2019

Primary Completion

March 1, 2022

Study Completion

March 1, 2022

Last Updated

February 8, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)