HIVCOVIDHIVPrEPNCT04379245
COVID-19 Infection in Patients Infected With HIV and/or on PrEP
An observational study of HIV and Pre-exposure Prophylaxis, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The SARS-CoV-2 epidemic was declared as a global pandemic by the WHO on March 12, 2020. France is affected with approximately 120,000 biologically confirmed cases, as of April 30, 2020, a figure probably very underestimated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Pre-exposure Prophylaxis
- What is being tested?
- Data research, database analysis
- How many people
- 4,200 participants
- Where
- 1 siteFrance
- Study dates
- 30 Apr 2020to 4 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Two populations will be studied: * HIV patients in Hospices Civils de Lyon * on PrEP patients in Hospices Civils de Lyon
Who may be able to join
- HIV patients in Hospices Civils de Lyon
- on-PrEP patients in Hospices Civils de Lyon
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Attack Rate of COVID-19 Infection in Patients Infected With HIV and/or on Pre-exposure Prophylaxis (PrEP) and Possible Impact of Treatment With an HIV Protease Inhibitor
The SARS-CoV-2 epidemic was declared as a global pandemic by the WHO on March 12, 2020. France is affected with approximately 120,000 biologically confirmed cases, as of April 30, 2020, a figure probably very underestimated. Its distribution in different populations, in particular immunocompromised, has not yet been measured. The in vitro efficacy of lopinavir coupled with ritonavir, an HIV protease inhibitor, on SARS-CoV, responsible for SARS has been discussed and this therapeutic combination is currently being evaluated in patients infected with COVID-19. The possible protective role of treatment with Lopinavir / ritonavir or another HIV protease inhibitor has not been studied.
In addition, patients receiving HIV pre-exposure prophylaxis (PrEP) share certain epidemiological and behavioral characteristics with HIV-infected patients.
Read more
The objective was to carry out an epidemiological study aimed at determining the attack rate of COVID-19 infection in patients infected with HIV and or on PrEP and to analyze this attack rate according to the characteristics of these 2 populations and in particular the existence or not of an antiretroviral treatment comprising Lopinavir / Ritonavir or another inhibitor of the HIV protease.
Cross-referencing of Virology Laboratory data (positive or negative screening) and clinical-biological data can be easily carried out using a unique identification number in the 2 software programs and will allow an almost exhaustive epidemiological analysis in 2 well identified populations.
- Conditions
- HIV, Pre-exposure Prophylaxis
- Being tested
- Data research, database analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data research, database analysisOther
Extraction of virological data at the virology laboratory (date, SARS-COV2 PCR result, identification number, sex, date of birth) (Excel file)
- Extraction of demographic and viro-immunological data from patients infected with HIV and on PrEP followed at the Hospices Civils de Lyon, France, over the period concerned (Access extraction)
- Data crossing (Excel / Access) and statistical analysis
- Calculation of the positivity rate per calendar period (= number of diagnosed cases / number of patients tested) and the attack rate per calendar period (number of diagnosed cases / number of people exposed (= active file of patients followed reduced by the number already known to be positive)).
What is being measured
The primary outcome is the main question the study is designed to answer.
Covid attack rate
Cross-referencing of Virology Laboratory data (positive or negative screening) and clinical-biological data using the unique identification number in the 2 databases. This cross-checking of files will allow an almost exhaustive epidemiological analysis in 2 well identified populations.
Measured: During hospitalisation for Covid symptoms: one week (max 2 weeks) after symptoms initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start30 Apr 2020
- Primary completion30 Apr 2020
- Study completion4 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 4,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04379245
- Sponsor's protocol ID
- CRC_GHN_2020_002
- Acronym
- COVIDHIVPrEP
- Status last verified
- May 2020
- First submitted
- 4 May 2020
- Last updated
- 7 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Attack Rate of COVID-19 Infection in Patients Infected With HIV and/or on Pre-exposure Prophylaxis (PrEP) and Possible Impact of Treatment With an HIV Protease Inhibitor
- ClinicalTrials.gov ID
- NCT04379245
- Acronym / sponsor ID
- COVIDHIVPrEP / CRC_GHN_2020_002
- Conditions
- HIV, Pre-exposure Prophylaxis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,200 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 30 Apr 2020 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 4 May 2020 (actual)
- First posted
- 7 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The SARS-CoV-2 epidemic was declared as a global pandemic by the WHO on March 12, 2020. France is affected with approximately 120,000 biologically confirmed cases, as of April 30, 2020, a figure probably very underestimated. Its distribution in different populations, in particular immunocompromised, has not yet been measured. The in vitro efficacy of lopinavir coupled with ritonavir, an HIV protease inhibitor, on SARS-CoV, responsible for SARS has been discussed and this therapeutic combination is currently being evaluated in patients infected with COVID-19. The possible protective role of treatment with Lopinavir / ritonavir or another HIV protease inhibitor has not been studied.
In addition, patients receiving HIV pre-exposure prophylaxis (PrEP) share certain epidemiological and behavioral characteristics with HIV-infected patients.
The objective was to carry out an epidemiological study aimed at determining the attack rate of COVID-19 infection in patients infected with HIV and or on PrEP and to analyze this attack rate according to the characteristics of these 2 populations and in particular the existence or not of an antiretroviral treatment comprising Lopinavir / Ritonavir or another inhibitor of the HIV protease.
Cross-referencing of Virology Laboratory data (positive or negative screening) and clinical-biological data can be easily carried out using a unique identification number in the 2 software programs and will allow an almost exhaustive epidemiological analysis in 2 well identified populations.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Two populations will be studied: * HIV patients in Hospices Civils de Lyon * on PrEP patients in Hospices Civils de Lyon
Key inclusion criteria (2 listed)
- HIV patients in Hospices Civils de Lyon
- on-PrEP patients in Hospices Civils de Lyon
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data research, database analysisExtraction of virological data at the virology laboratory (date, SARS-COV2 PCR result, identification number, sex, date of birth) (Excel file) * Extraction of demographic and viro-immunological data from patients infected with HIV and on PrEP followed at the Hospices Civils de Lyon, France, over the period concerned (Access extraction) * Data crossing (Excel / Access) and statistical analysis * Calculation of the positivity rate per calendar period (= number of diagnosed cases / number of patients tested) and the attack rate per calendar period (number of diagnosed cases / number of people exposed (= active file of patients followed reduced by the number already known to be positive)). | Other | – |
Primary outcome
Covid attack rate
Time frame: During hospitalisation for Covid symptoms: one week (max 2 weeks) after symptoms initiation
Cross-referencing of Virology Laboratory data (positive or negative screening) and clinical-biological data using the unique identification number in the 2 databases. This cross-checking of files will allow an almost exhaustive epidemiological analysis in 2 well identified populations.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV and Pre-exposure Prophylaxis, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Covid attack rate (time frame: During hospitalisation for Covid symptoms: one week (max 2 weeks) after symptoms initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2020.