HIV InfectionsCoDARNCT03042390
Study of the Effectiveness and Safety of Darunavir/Cobicistat (DRV/c) Containing Regimens in Routine Clinical Practice
An observational study of HIV Infections, run by Fundacion SEIMC-GESIDA at 20 sites in Spain.
Trial summary
This is a retrospective observational study of patients who have taken a regimen containing DRV / c at least 24 weeks prior to study initiation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- How many people
- 762 participants
- Where
- 20 sitesSpain
- Study dates
- 23 Dec 2016to 9 May 2017
- 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: HIV patients that initiated treatment with a régimen containing DRV/c at least 24 weeks prior initiation of study.
Who may be able to join
- Patients with HIV infection
- Inform consent document.
- To have initiated therapy containing DRV / c and have a follow-up of at least 24 Weeks.
Who cannot join
- Not having evaluable clinical data of the patient
- Patients not routinely followed in the center
- Patient less than 18 years of age.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Spain20 sites
Hospital Clinic i Provincial
Barcelona
Hospital de la Santa Creu i Sant Pau
Barcelona
Hospital del Mar
Barcelona
Hospital del Vall d'Hebron
Barcelona
Hospital Germans Trias i Pujol
Barcelona
Hospital de Guadalajara
Guadalajara
Hospital Infanta Leonor
Madrid
Hospital La Paz
Madrid
Hospital La Princesa
Madrid
Hospital Príncipe de Asturias
Madrid
Hospital Puerta de Hierro
Madrid
Hospital Ramón y Cajal
Madrid
Hospital Costa del Sol
Málaga, Marbella
Hospital Virgen de la Victoria
Málaga
Hospital de Son Llatzer
Palma de Mallorca
Hospital de Valme
Seville
Complejo Hospitalario de Toledo
Toledo
Hospital Clínico de Valencia
Valencia
Hospital La Fe
Valencia
Complejo Hospitalaria Alvaron Cunqueiro
Vigo
About this study
Official title: Multicenter Retrospective Study of the Effectiveness and Safety of Darunavir/Cobicistat (DRV/c) Containing Regimens in Routine Clinical Practice
This is a retrospective observational study of patients who have taken a regimen containing DRV / c at least 24 weeks prior to study initiation
Read the detailed description
The study will include 750 patients and will record data at 24 weeks. The study will also record data at 48 weeks for those patients whom these data are available
- Conditions
- HIV Infections
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| DArunavir/cobicistat | Patients starting treatment with a regimen containing Darunavir / cobicistat for at least 24 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Virological effectiveness data: Percentage of patients with undetectable viral load
Virological effectiveness data at 24 weeks: Percentage of patients with undetectable viral load, defined as HIV RNA <50 copies / m.
Measured: 24 weeks
Virological effectiveness data: change in the number of CD4 + T cells at 24 weeks
Change in the number of CD4 + T cells at 24 weeks
Measured: 24 weeks
Virological effectiveness data: time to loss of virological efficacy.
Defined virological failure as two consecutive levels of HIV RNA > 50 copies / mL or single HIV RNA ≥ 500 copies / mL
Measured: 24 weeks
Secondary outcomes (11)
Virological effectiveness data: Percentage of patients with undetectable viral load, defined as HIV RNA levels ≤ 50 copies / mL or limit of detection of the center, at 48 weeks
Virological effectiveness data at 48 weeks
Measured: 48 weeks
Virological effectiveness data: change in the number of CD4 + T cells, at 48 weeks
Virological effectiveness data at 48 weeks: change in the number of CD4 + T cells
Measured: 48 weeks
Changes in the renal profile: Comparison of mean values of Creatinine and eFG (CKD-EPI).
Creatinine (mg/dl), eFG (CKD-EPI) (ml/min/1,73 m2),
Measured: Basal and 24 weeks/48 weeks
Changes in the lipid profile: Comparison of mean values of total cholesterol values, Col LDL, Col HDL and TG.
Units: mg/dl or mmol/l
Measured: basal and 24 weeks/48 weeks
Changes in the hepatic profile: comparison of mean values of GOT, GPT, FA, GGT and BrT
GOT, GPT, FA, GGT in units: UI/l or μKat/l or mU/ml. BrT in units: mg/dl or micromol/l
Measured: basal and 24 weeks/48 weeks
Tolerability data:Rate of patients discontinuing treatment for toxicity.
Toxicity to the treatment or virological failure
Measured: 24 weeks/48 weeks
Tolerability data: Rate of patients discontinuing treatment for virological failure at 24 weeks / 48 weeks
Virological failure defined as two consecutive levels of HIV RNA > 50 copies / mL or single HIV RNA ≥ 500 copies / mL
Measured: 24 weeks/48 weeks
Rate of patients who develop any adverse effects:frequency of adverse events,frequency of serious adverse events, frequency of adverse events leading to discontinuation of treatment, number of deaths and frequency of laboratory abnormalities.
Measured: 24 weeks/48 weeks
Representative subgroups of patients according to the treatment that patient is taking: Percentage of patients with different Darunavir/cobicistat based regimens (Monotherapy, Bitherapy, triple Therapy, others)
Measured: 24 weeks / 48 weeks
Provenance treatments: Percentage of patients with different prior therapies (Darunavir Therapy, Other PI therapies, NNRTI based regimen, INI bases regimen
Measured: 24 weeks / 48 weeks
Reason for the change prior the initiation:Percentage of patients with each main reason to change to a DRV/c based regimen (first regimen, simplification, intolerance or toxicity, prior adherence problems, prior interactions, prior failure, others)
Measured: 24 weeks / 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study start23 Dec 2016
- Primary completion9 May 2017
- Study completion9 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 762 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion SEIMC-GESIDA
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen-Cilag, S.A.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03042390
- Sponsor's protocol ID
- GESIDA 9316
- Acronym
- CoDAR
- Status last verified
- Dec 2016
- First submitted
- 19 Dec 2016
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Perez Elias MJ, Alejos B, Gutierrez MM, Crespo M, De Los Santos Gil I, Ribera E, Galindo MJ, Lozano F, Payeras Cifre A, Boix V, Montero-Alonso M, Sanz J, De La Torre Lima J, Palacios R, De La Fuente Moral S, Martinez E; Codar Study Group. Dynamics of creatinine estimated glomerular filtration rate using one or more antiretrovirals that inhibit creatinine tubular secretion. J Antimicrob Chemother. 2021 Mar 12;76(4):1046-1050. doi: 10.1093/jac/dkaa547.
PubMed 33501995Perez Elias MJ, Alejos B, Vivancos MJ, Ribera E, Galindo MJ, Vilanova-Trillo L, Garcia-Fraile Fraile LJ, de La Fuente Moral S, Garcia De Lomas J, Lozano F, Mateo Garcia MG, Tasias Pitarch M, Diez Martinez M, Rojas J, Raya-Cruz M, Sepulveda MA, Troya J, Del Campo S, Martinez E; CODAR study group. Outcomes by sex following treatment initiation with darunavir/cobicistat in a large Spanish cohort of the CODAR study (GeSIDA 9316). J Antimicrob Chemother. 2019 Oct 1;74(10):3044-3048. doi: 10.1093/jac/dkz254.
PubMed 31236601
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Retrospective Study of the Effectiveness and Safety of Darunavir/Cobicistat (DRV/c) Containing Regimens in Routine Clinical Practice
- ClinicalTrials.gov ID
- NCT03042390
- Acronym / sponsor ID
- CoDAR / GESIDA 9316
- Conditions
- HIV Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 762 participants (actual)
- Lead sponsor
- Fundacion SEIMC-GESIDAUniversity, hospital or other
- Collaborators
- Janssen-Cilag, S.A.
- Study start
- 23 Dec 2016 (actual)
- Primary completion
- 9 May 2017 (actual)
- Study completion
- 9 May 2017 (actual)
- First posted
- 3 Feb 2017 (estimated)
- 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.
This is a retrospective observational study of patients who have taken a regimen containing DRV / c at least 24 weeks prior to study initiation
Detailed description
The study will include 750 patients and will record data at 24 weeks. The study will also record data at 48 weeks for those patients whom these data are available
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DArunavir/cobicistat | – | –Patients starting treatment with a regimen containing Darunavir / cobicistat for at least 24 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV patients that initiated treatment with a régimen containing DRV/c at least 24 weeks prior initiation of study.
Key inclusion criteria (3 listed)
- Patients with HIV infection
- Inform consent document.
- To have initiated therapy containing DRV / c and have a follow-up of at least 24 Weeks.
Key exclusion criteria (3 listed)
- Not having evaluable clinical data of the patient
- Patients not routinely followed in the center
- Patient less than 18 years of age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Virological effectiveness data: Percentage of patients with undetectable viral load
Time frame: 24 weeks
Virological effectiveness data at 24 weeks: Percentage of patients with undetectable viral load, defined as HIV RNA <50 copies / m.
Virological effectiveness data: change in the number of CD4 + T cells at 24 weeks
Time frame: 24 weeks
Change in the number of CD4 + T cells at 24 weeks
Virological effectiveness data: time to loss of virological efficacy.
Time frame: 24 weeks
Defined virological failure as two consecutive levels of HIV RNA > 50 copies / mL or single HIV RNA ≥ 500 copies / mL
11 secondary outcomes
Virological effectiveness data: Percentage of patients with undetectable viral load, defined as HIV RNA levels ≤ 50 copies / mL or limit of detection of the center, at 48 weeks
Time frame: 48 weeks
Virological effectiveness data: change in the number of CD4 + T cells, at 48 weeks
Time frame: 48 weeks
Changes in the renal profile: Comparison of mean values of Creatinine and eFG (CKD-EPI).
Time frame: Basal and 24 weeks/48 weeks
Changes in the lipid profile: Comparison of mean values of total cholesterol values, Col LDL, Col HDL and TG.
Time frame: basal and 24 weeks/48 weeks
Changes in the hepatic profile: comparison of mean values of GOT, GPT, FA, GGT and BrT
Time frame: basal and 24 weeks/48 weeks
Tolerability data:Rate of patients discontinuing treatment for toxicity.
Time frame: 24 weeks/48 weeks
Tolerability data: Rate of patients discontinuing treatment for virological failure at 24 weeks / 48 weeks
Time frame: 24 weeks/48 weeks
Rate of patients who develop any adverse effects:frequency of adverse events,frequency of serious adverse events, frequency of adverse events leading to discontinuation of treatment, number of deaths and frequency of laboratory abnormalities.
Time frame: 24 weeks/48 weeks
Representative subgroups of patients according to the treatment that patient is taking: Percentage of patients with different Darunavir/cobicistat based regimens (Monotherapy, Bitherapy, triple Therapy, others)
Time frame: 24 weeks / 48 weeks
Provenance treatments: Percentage of patients with different prior therapies (Darunavir Therapy, Other PI therapies, NNRTI based regimen, INI bases regimen
Time frame: 24 weeks / 48 weeks
Reason for the change prior the initiation:Percentage of patients with each main reason to change to a DRV/c based regimen (first regimen, simplification, intolerance or toxicity, prior adherence problems, prior interactions, prior failure, others)
Time frame: 24 weeks / 48 weeks
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 5 Feb 2020.
- Derived from this study: PubMed 33501995Perez Elias MJ, Alejos B, Gutierrez MM, Crespo M, De Los Santos Gil I, Ribera E, Galindo MJ, Lozano F, Payeras Cifre A, Boix V, Montero-Alonso M, Sanz J, De La Torre Lima J, Palacios R, De La Fuente Moral S, Martinez E; Codar Study Group. Dynamics of creatinine estimated glomerular filtration rate using one or more antiretrovirals that inhibit creatinine tubular secretion. J Antimicrob Chemother. 2021 Mar 12;76(4):1046-1050. doi: 10.1093/jac/dkaa547.
- Derived from this study: PubMed 31236601Perez Elias MJ, Alejos B, Vivancos MJ, Ribera E, Galindo MJ, Vilanova-Trillo L, Garcia-Fraile Fraile LJ, de La Fuente Moral S, Garcia De Lomas J, Lozano F, Mateo Garcia MG, Tasias Pitarch M, Diez Martinez M, Rojas J, Raya-Cruz M, Sepulveda MA, Troya J, Del Campo S, Martinez E; CODAR study group. Outcomes by sex following treatment initiation with darunavir/cobicistat in a large Spanish cohort of the CODAR study (GeSIDA 9316). J Antimicrob Chemother. 2019 Oct 1;74(10):3044-3048. doi: 10.1093/jac/dkz254.
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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.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by Fundacion SEIMC-GESIDA at 20 sites in Spain.
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 3 inclusion and 3 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 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Spain. 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?
Virological effectiveness data: Percentage of patients with undetectable viral load (time frame: 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03042390, which also lists 2 linked publications.
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 5 Feb 2020.