NCT03349359

Brief Summary

Background: Cytomegalovirus (CMV) infection is usually observed among patients with HIV infection. No study to date has investigated the impact of CMV infection on HIV viral load decay during antiretroviral therapy. Methods: 345 consecutive HIV patients coinfected (N=300) or not (N=45) with CMV were enrolled. Clinical, biological and virological data were collected from HIV antiretroviral therapy initiation to the day of HIV viral load undetectability if any.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
345

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2016

Shorter than P25 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

November 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 21, 2017

Completed
Last Updated

November 21, 2017

Status Verified

November 1, 2017

Enrollment Period

3 months

First QC Date

November 17, 2017

Last Update Submit

November 17, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • HIV viral load undetectability

    HIV viral load was assessed during the follow-up visits after the initiation of antiretroviral therapy. HIV undetectability was defined by an HIV-RNA level \<50 copies/mL.

    From date of HIV therapy initiation until the date of HIV viral load undetectability (12 weeks in average after treatment initiation)

Interventions

HIV patients are receiving an antiretroviral therapy according to the physician's discretion and the availability of drugs

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

HIV-infected patients followed at the Department of Infectious Diseases, Croix-Rousse Hospital, Groupement Hospitalier Nord, Hospices Civils de Lyon, Lyon, France between June 2005 and July 2016 starting an antiretroviral treatment and with available CMV serology at treatment initiation.

You may qualify if:

  • HIV patients starting an antiretroviral therapy
  • CMV serology available at antiretroviral therapy initiation
  • HIV viral load assessed at each follow-up visit after treatment initiation

You may not qualify if:

  • HIV antiretroviral treatment initiation before June 2005

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Croix-Rousse Hospital, Hospices Civils de Lyon

Lyon, 69004, France

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2017

First Posted

November 21, 2017

Study Start

November 1, 2016

Primary Completion

January 30, 2017

Study Completion

January 30, 2017

Last Updated

November 21, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations