- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03349359
Impact of CMV Status on HIV Viral Load Decay
Impact of Cytomegalovirus (CMV) Status Prior Antiretroviral Therapy on HIV Viral Load Decay
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.
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Lyon, France, 69004
- Croix-Rousse hospital, Hospices Civils de Lyon
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- HIV antiretroviral treatment initiation before June 2005
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HIV viral load undetectability
Time Frame: From date of HIV therapy initiation until the date of HIV viral load undetectability (12 weeks in average after treatment initiation)
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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.
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From date of HIV therapy initiation until the date of HIV viral load undetectability (12 weeks in average after treatment initiation)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRC_GHN_2017_006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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