ClinicalTrials.gg
CompletedNCT03349359Updated Nov 21, 2017

Impact of CMV Status on HIV Viral Load Decay

An observational study in Hiv, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-21.

Primary conditionAcquired Immunodeficiency Syndrome(the registry's first term)UnverifiedIs this wrong?The registry often attaches Acquired Immunodeficiency Syndrome to studies about something else, and this study's title and listed conditions do not name it. No better condition is named, so the registry's term is kept.

Sponsored by Hospices Civils de Lyon · Observational

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Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
345
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hiv

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03

In context

Acquired Immunodeficiency Syndrome Unverified

3,037 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 307 are open to participants now.

This study's enrollment of 345 is above the median of 289 across 504 observational studies indexed under Acquired Immunodeficiency Syndrome.

Browse Acquired Immunodeficiency Syndrome studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,867 studies on the registry; 448 are open to participants now.

Compared within Acquired Immunodeficiency Syndrome, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • antiretroviral treatment initiation before June 2005
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
345 participants (actual)
Patient registry
No

Interventions

  • DrugHIV antiretroviral therapy

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

06

What researchers measure

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.

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

07

Study locations

1 site
  • Croix-Rousse Hospital, Hospices Civils de Lyon
    Lyon, 69004, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2016 to primary completion in Jan 2017, 2 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 17, 2017
First posted
Nov 21, 2017
StartActual
Nov 1, 2016
Primary completionActual
Jan 30, 2017
CompletionActual
Jan 30, 2017
Last update
Nov 21, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 21, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03349359
Responsible party
Sponsor
First posted
Nov 21, 2017
Start date
Nov 1, 2016
Primary completion
Jan 30, 2017
Completion
Jan 30, 2017
Last update
Nov 21, 2017

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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