NCT00702013

Brief Summary

The P-glycoprotein (P-gp) is a membranous transporter that modulates the intracellular concentrations of many drugs and plays thus a major role in the efficacy of the therapeutics that act within the lymphocytes, such as antiretroviral drugs. We aim at studying the evolution of this transporter's expression and activity on lymphocytes in relation with the human development from newborns to adults. We also aim at studying the influence of HIV and antiretroviral treatments on this transporter, especially anti-protease drugs, within the children population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
310

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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, 2007

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 18, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 19, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

November 11, 2010

Status Verified

October 1, 2010

Enrollment Period

2 years

First QC Date

June 18, 2008

Last Update Submit

November 10, 2010

Conditions

HIV Infections

Keywords

P-glycoproteinlymphocyteHIVchildrenontogenesisOntogenesis P-gp in human lymphocytesStudy of the influence of HIV infectionAntiretroviral treatments on P-gp activityExpression in human lymphocytes

Outcome Measures

Primary Outcomes (1)

  • The activity and expression of P-glycoprotein at the time when the blood sample was taken.

    immediately

Study Arms (8)

1

2

3

4

5

6

7

8

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

HIV Patients children and adults and controls

You may qualify if:

  • age, HIV status

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Necker Enfants Malades

Paris, 75015, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood sample for DNA extraction and genetic polymorphism of Mdr1

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

  • Jean-Marc Tréluyer, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 18, 2008

First Posted

June 19, 2008

Study Start

March 1, 2007

Primary Completion

March 1, 2009

Study Completion

August 1, 2009

Last Updated

November 11, 2010

Record last verified: 2010-10

Locations

FR(1)