HIV InfectionEXTATICNCT01805427
Antiretroviral Therapy and Extreme Weight
An observational study of HIV Infection, run by Hopital Lariboisière at 1 site in France.
Trial summary
The concentration of the third agent in antiretroviral therapy [Non Nucleoside Reverse Transcriptase Inhibitor (NNRTI), or boosted Protease inhibitor (PI) ] is different according to the body weight or body composition and therapeutic monitoring may be necessary in overweight HIV patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- HIV Infection
- How many people
- 140 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2012to Nov 2013
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV-infected patients aged 18 years and older, treated with either efavirenz, atazanavir, or darunavir for at least 4 weeks and under stable treatment regimen
Who may be able to join
- Patients with HIV+ receiving one of the following third agent their HAART: efavirenz, atazanavir , or darunavir
- Patients aged > 18 years old.
- Patient giving its well-informed and free consent. Patient giving its well-informed and free consent.
- Patients living in France during the study.
Who cannot join
- Treatment with rifampin/rifabutin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Extreme Weights and Antiretroviral Therapy Individual Concentrations
The concentration of the third agent in antiretroviral therapy [Non Nucleoside Reverse Transcriptase Inhibitor (NNRTI), or boosted Protease inhibitor (PI) ] is different according to the body weight or body composition and therapeutic monitoring may be necessary in overweight HIV patients.
The investigators aim at measuring the individual trough concentrations of interest [at steady state for NNRTI and boosted PI] in overweight and normal weight HIV+ patients.
Read the detailed description
Our primary endpoint is the individual trough concentrations of interest at steady state for NNRTI or boosted PI; Principal outcome measure: comparison of the concentrations between patients <25kg/m2 and patients<25kg/m2
Secondary endpoints:
- Occurrence of virologic failure
- Occurrence of clinical/biological adverse events
- Percentage of patients with concentration within the therapeutic range
- Body composition Secondary outcome measures: comparison of the occurrence of virologic failure, occurrence or adverse event, patients with concentration within the therapeutic range between groups. Correlation between body composition and concentration.
Methodology, study design:
open-labelled monocentric study.
Sample size:
It will be a descriptive experimental study involving 120 overweight subjects, 120 normal weight subjects
Inclusion criteria :
- Patients with HIV+
- Patients aged more than 18 years old.
- Patient giving its well-informed and free consent.
Study design :
Plasma concentration was performed during the usual clinical follow-up. Study duration: 12 months Duration for a patient: 1 day Investigating center and participating units: one center enrolling the patients and the lab performing drug dosages.
- Conditions
- HIV Infection
- Keywords
- trough concentration, weight, HIV, virological failure
- Medical subject headings
- HIV Infections, Body Weight
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 |
|---|---|---|
| patients treated with efavirenz | HIV-infected on stable HAART regimen with efavirenz | |
| patients treated with atazanavir | HIV-infected patients on stable HAART regimen with atazanavir | |
| patients treated with darunavir | HIV-infected patients on stable HAART regimen with darunavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of the trough concentrations between patients with Body Mass Index (BMI)<25 kg/m2 and patients with BMI >25 kg/m2
Measured: the day of enrollment
Secondary outcomes (1)
comparison of the occurrence of virologic failure within each patient group
Measured: the day of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2013 (estimated)
- Study startSep 2012
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Lariboisière
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephane Mouly, MD PhD, Hopital Lariboisière
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01805427
- Sponsor's protocol ID
- EXTATIC
- Other IDs
- EXTATIC
- Acronym
- EXTATIC
- Status last verified
- Dec 2013
- First submitted
- 28 Feb 2013
- Last updated
- 6 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extreme Weights and Antiretroviral Therapy Individual Concentrations
- ClinicalTrials.gov ID
- NCT01805427
- Acronym / sponsor ID
- EXTATIC / EXTATIC
- Conditions
- HIV Infection
- Keywords
- trough concentration, weight, HIV, virological failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Hopital LariboisièreUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 6 Mar 2013 (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.
The concentration of the third agent in antiretroviral therapy [Non Nucleoside Reverse Transcriptase Inhibitor (NNRTI), or boosted Protease inhibitor (PI) ] is different according to the body weight or body composition and therapeutic monitoring may be necessary in overweight HIV patients.
The investigators aim at measuring the individual trough concentrations of interest [at steady state for NNRTI and boosted PI] in overweight and normal weight HIV+ patients.
Detailed description
Our primary endpoint is the individual trough concentrations of interest at steady state for NNRTI or boosted PI; Principal outcome measure: comparison of the concentrations between patients <25kg/m2 and patients<25kg/m2
Secondary endpoints:
- Occurrence of virologic failure
- Occurrence of clinical/biological adverse events
- Percentage of patients with concentration within the therapeutic range
- Body composition Secondary outcome measures: comparison of the occurrence of virologic failure, occurrence or adverse event, patients with concentration within the therapeutic range between groups. Correlation between body composition and concentration.
Methodology, study design:
open-labelled monocentric study.
Sample size:
It will be a descriptive experimental study involving 120 overweight subjects, 120 normal weight subjects
Inclusion criteria :
- Patients with HIV+
- Patients aged more than 18 years old.
- Patient giving its well-informed and free consent.
Study design :
Plasma concentration was performed during the usual clinical follow-up. Study duration: 12 months Duration for a patient: 1 day Investigating center and participating units: one center enrolling the patients and the lab performing drug dosages.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| patients treated with efavirenz | – | –HIV-infected on stable HAART regimen with efavirenz |
| patients treated with atazanavir | – | –HIV-infected patients on stable HAART regimen with atazanavir |
| patients treated with darunavir | – | –HIV-infected patients on stable HAART regimen with darunavir |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV-infected patients aged 18 years and older, treated with either efavirenz, atazanavir, or darunavir for at least 4 weeks and under stable treatment regimen
Key inclusion criteria (4 listed)
- Patients with HIV+ receiving one of the following third agent their HAART: efavirenz, atazanavir , or darunavir
- Patients aged > 18 years old.
- Patient giving its well-informed and free consent. Patient giving its well-informed and free consent.
- Patients living in France during the study.
Key exclusion criteria (1 listed)
- Treatment with rifampin/rifabutin
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
comparison of the trough concentrations between patients with Body Mass Index (BMI)<25 kg/m2 and patients with BMI >25 kg/m2
Time frame: the day of enrollment
1 secondary outcome
comparison of the occurrence of virologic failure within each patient group
Time frame: the day of enrollment
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 6 Dec 2013.
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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 Infection, run by Hopital Lariboisière 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 4 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 6 Dec 2013. 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?
comparison of the trough concentrations between patients with Body Mass Index (BMI)<25 kg/m2 and patients with BMI >25 kg/m2 (time frame: the day of enrollment). 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 6 Dec 2013.