HIVPhase 4NCT00299091
Modification of Doses of Efavirenz According to Its Blood Concentration in HIV Patients
A Phase 4 study testing Efavirenz capsules 200 mg and 600 mg in people with HIV, run by Germans Trias i Pujol Hospital at 1 site in Spain.
Trial summary
This is a study on the utility of the modification of doses of efavirenz guided by its plasma concentration (therapeutic drug monitoring) in HIV-infected patients initiating treatment with Sustiva. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV
- What is being tested?
- Efavirenz capsules 200 mg and 600 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2006to Oct 2008
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-1 patients.
- According to the criteria of the treating physician, the need to initiate a regimen of antiretroviral treatment that includes efavirenz (both antiretroviral-naive patients and others on treatment with protease inhibitors switching to efavirenz for salvage reasons or for simplification of the anti-retroviral therapy are included).
- Absence of opportunistic infections and/or tumours in the three months prior to inclusion.
Who cannot join
- History of allergic hypersensitivity to the investigational drug.
- History of previous failure with antiretroviral treatment with non-nucleoside reverse transcriptase inhibitors or previously documented resistance to efavirenz
- History of psychiatric comorbidity which, in the investigator's opinion, renders the use of efavirenz inadvisable.
- Active consumption of alcohol (>50 g/day) or other illegal drugs (except cannabis)
- Suspicion of unsuitable compliance with the antiretroviral treatment.
- Pregnant women or breast-feeding mothers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open, Parallel and Randomised Pilot Clinical Trial to Evaluate the Utility of the Therapeutic Monitoring of Plasma Levels of Efavirenz in Hiv-Infected Patients Initiating an Antiretroviral Treatment Regimen With Sustiva
This is a study on the utility of the modification of doses of efavirenz guided by its plasma concentration (therapeutic drug monitoring) in HIV-infected patients initiating treatment with Sustiva.
Read the detailed description
Currently, efavirenz is dosed systematically, without taking into account the individual characteristics of each individual patient. However, plasma concentration of efavirenz may widely vary between different subjects that receive the same dose of the drug (interindividual variability).
Therapeutic drug monitoring (TDM) signifies individualised pharmacological dosing, based on the plasma levels that each patient presents. This strategy has been broadly used in the field of the treatment of other medical conditions and is acquiring growing interest in the field of antiretroviral treatment. Thus, the use of TDM for the treatment of naïve patients with nelfinavir or with indinavir has translated into an increase in the proportion of individuals with suppressed viral load and also into a reduction in HAART-induced adverse events . However, data on the utility of the therapeutic monitoring of the levels of efavirenz in HIV-infected patients are very scant.
On the basis of the above, it might be thought that the modification of the doses of efavirenz, guided by its plasma concentration, in patients receiving this drug and whose plasma levels of efavirenz are outside the therapeutic range, might improve the tolerability of the treatment without compromising virological efficacy.
- Conditions
- HIV
- Being tested
- Efavirenz capsules 200 mg and 600 mg
- Keywords
- Therapeutic drug monitoring, Treatment Naive, Treatment Experienced, HIV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efavirenz capsules 200 mg and 600 mgDrug
Also called Sustiva
Modification of doses of efavirenz guided by its plasma concentration (therapeutic drug monitoring)
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Efavirenz capsules 600 mg |
| Experimental | Experimental | Modification of doses of efavirenz guided by its plasma concentration (therapeutic drug monitoring) Receives: Drug: Efavirenz capsules 200 mg and 600 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients who need to interrupt treatment with efavirenz due to virological failure
Measured: after 96 weeks of follow-up
Secondary outcomes (5)
The proportion of patients who need to interrupt treatment with efavirenz due to adverse side effects
Measured: after 96 weeks of follow-up
To determine the incidence of adverse events and the toxicity profile (haemogram, AST/ALT/FA/GGT, creatinine, urea)
Measured: during the 96 weeks of follow-up
To evaluate the proportion of patients with plasma levels of efavirenz between 1.0 and 4.0 mg/L
Measured: during the 96 weeks of follow-up
To evaluate the relationship between the appearance of secondary events during treatment with efavirenz and the patients' demographic and clinical characteristics, as well the plasma concentration of efavirenz
Measured: during the 96 weeks of follow-up
To evaluate the variations in CD4 and CD8 lymphocyte count
Measured: during the 96 weeks of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2006 (estimated)
- Study startSep 2006
- Primary completionOct 2008
- Study completionOct 2008
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.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Germans Trias i Pujol Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr . BONAVENTURA CLOTET, Germans Trias i Pujol Hospital
- Investigators
- Bonaventura Clotet, MD, PhD, Principal investigator, Lluita Sida Foundation-HIV Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00299091
- Sponsor's protocol ID
- startTDM-EFV
- Other IDs
- 2005-002493-30, 2005
- Status last verified
- Feb 2018
- First submitted
- 3 Mar 2006
- Last updated
- 14 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, Parallel and Randomised Pilot Clinical Trial to Evaluate the Utility of the Therapeutic Monitoring of Plasma Levels of Efavirenz in Hiv-Infected Patients Initiating an Antiretroviral Treatment Regimen With Sustiva
- ClinicalTrials.gov ID
- NCT00299091
- Acronym / sponsor ID
- startTDM-EFV
- Conditions
- HIV
- Keywords
- Therapeutic drug monitoring, Treatment Naive, Treatment Experienced, HIV
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Germans Trias i Pujol HospitalUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 6 Mar 2006 (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 study on the utility of the modification of doses of efavirenz guided by its plasma concentration (therapeutic drug monitoring) in HIV-infected patients initiating treatment with Sustiva.
Detailed description
Currently, efavirenz is dosed systematically, without taking into account the individual characteristics of each individual patient. However, plasma concentration of efavirenz may widely vary between different subjects that receive the same dose of the drug (interindividual variability).
Therapeutic drug monitoring (TDM) signifies individualised pharmacological dosing, based on the plasma levels that each patient presents. This strategy has been broadly used in the field of the treatment of other medical conditions and is acquiring growing interest in the field of antiretroviral treatment. Thus, the use of TDM for the treatment of naïve patients with nelfinavir or with indinavir has translated into an increase in the proportion of individuals with suppressed viral load and also into a reduction in HAART-induced adverse events . However, data on the utility of the therapeutic monitoring of the levels of efavirenz in HIV-infected patients are very scant.
On the basis of the above, it might be thought that the modification of the doses of efavirenz, guided by its plasma concentration, in patients receiving this drug and whose plasma levels of efavirenz are outside the therapeutic range, might improve the tolerability of the treatment without compromising virological efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Efavirenz capsules 600 mg |
| Experimental | Experimental | Drug: Efavirenz capsules 200 mg and 600 mgModification of doses of efavirenz guided by its plasma concentration (therapeutic drug monitoring) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- HIV-1 patients.
- According to the criteria of the treating physician, the need to initiate a regimen of antiretroviral treatment that includes efavirenz (both antiretroviral-naive patients and others on treatment with protease inhibitors switching to efavirenz for salvage reasons or for simplification of the anti-retroviral therapy are included).
- Absence of opportunistic infections and/or tumours in the three months prior to inclusion.
Key exclusion criteria (6 listed)
- History of allergic hypersensitivity to the investigational drug.
- History of previous failure with antiretroviral treatment with non-nucleoside reverse transcriptase inhibitors or previously documented resistance to efavirenz
- History of psychiatric comorbidity which, in the investigator's opinion, renders the use of efavirenz inadvisable.
- Active consumption of alcohol (>50 g/day) or other illegal drugs (except cannabis)
- Suspicion of unsuitable compliance with the antiretroviral treatment.
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 |
|---|---|---|
| Efavirenz capsules 200 mg and 600 mgAlso: SustivaModification of doses of efavirenz guided by its plasma concentration (therapeutic drug monitoring) | Drug | Experimental |
Primary outcome
The proportion of patients who need to interrupt treatment with efavirenz due to virological failure
Time frame: after 96 weeks of follow-up
5 secondary outcomes
The proportion of patients who need to interrupt treatment with efavirenz due to adverse side effects
Time frame: after 96 weeks of follow-up
To determine the incidence of adverse events and the toxicity profile (haemogram, AST/ALT/FA/GGT, creatinine, urea)
Time frame: during the 96 weeks of follow-up
To evaluate the proportion of patients with plasma levels of efavirenz between 1.0 and 4.0 mg/L
Time frame: during the 96 weeks of follow-up
To evaluate the relationship between the appearance of secondary events during treatment with efavirenz and the patients' demographic and clinical characteristics, as well the plasma concentration of efavirenz
Time frame: during the 96 weeks of follow-up
To evaluate the variations in CD4 and CD8 lymphocyte count
Time frame: during the 96 weeks of follow-up
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 14 Feb 2018.
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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.
Bonaventura Clotet, MD, PhD principal investigator
Lluita Sida Foundation-HIV Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Efavirenz capsules 200 mg and 600 mg in people with HIV, run by Germans Trias i Pujol Hospital at 1 site 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 6 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 14 Feb 2018. 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The proportion of patients who need to interrupt treatment with efavirenz due to virological failure (time frame: after 96 weeks of follow-up). 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 14 Feb 2018.