HIV-1 InfectionPhase 4RAETNCT01121809
Plasma and Intracellular Concentrations of Raltegravir and Etravirine Administered Once Daily
A Phase 4 study testing Raltegravir and Etravirine in people with HIV-1 Infection and HIV Infections, run by Hospitales Universitarios Virgen del Rocío at 1 site in Spain.
Trial summary
Hypothesis: the intracellular concentrations of raltegravir (RAL) and etravirine (ETV) administrated as 800 and 400 mg once a day, respectively, are similar to those obtained with the standard doses of 400 and 200 mg/12h, respectively. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV-1 Infection, HIV Infections
- What is being tested?
- Raltegravir and Etravirine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2010to Jan 2011
- 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
- Adult HIV-1-infected patients taking raltegravir- or etravirine-based antiretroviral regimens
Who cannot join
- Pregnancy
- Concomitant use of drugs that have potential interactions with raltegravir or etravirine pharmacokinetics
- Cirrhosis with clinical or analytic data of liver failure.
- Clinical history suggesting malabsorption or presence of diarrhea (> 3 stools / day) that could interfere with the absorption of study drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Plasma and Intracellular Concentrations of Raltegravir and Etravirine Administered Once Daily (800 mg and 400 mg, Respectively) Compared With Standard Dosing (400 mg and 200 mg/12 h) in Patients With HIV Infection
Hypothesis: the intracellular concentrations of raltegravir (RAL) and etravirine (ETV) administrated as 800 and 400 mg once a day, respectively, are similar to those obtained with the standard doses of 400 and 200 mg/12h, respectively.
Objective: To analyze the plasma and intracellular concentrations of RAL and ETV administrated as 800 and 400 mg once daily respectively compared with standard doses of 400 and 200 mg/12h, respectively, and if they support its once daily administration.
Read the detailed description
Objective: To analyze the plasma and intracellular concentrations of RAL and ETV administrated as 800 and 400 mg once daily respectively compared with standard doses of 400 and 200 mg/12h, respectively, and if they support its once daily administration.
Method: Phase IV, prospective, open labelled clinical trial with a planned duration of 24 weeks in which 16 patients from Hospitales Universitarios Virgen del Rocío will be enrolled. A 12 hours pharmacokinetic profile (immediately before and after 1, 2, 3, 4, 6, 8, 10 and 12 h) will be obtained after a supervised drug intake while taking RAL or ETV bid. Afterwards,the patients will take RAL or ETV once a day for 7 - 10 days. Subsequently, a new pharmacokinetic profile (predose and after 1, 2, 3, 4, 6, 8, 10, 12, 16, 20 and 24 h after a supervised drug intake) will be obtained.
- Conditions
- HIV-1 Infection, HIV Infections
- Being tested
- Raltegravir, Etravirine
- Keywords
- Raltegravir, etravirine, pharmacokinetics, intracellular
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RaltegravirDrug
Changing the dose of raltegravir from 400 mg bid to 800 mg qd
EtravirineDrug
Changing the dose of etravirine from 200 mg bid to 400 mg qd
| Study group | Role | What they receive |
|---|---|---|
| Raltegravir | Other | Raltegravir 400 mg bid Receives: Drug: Raltegravir |
| Etravirine | Other | Etravirine 200 mg bid Receives: Drug: Etravirine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in pharmacokinetic parameters (Cmax, Cmin, AUC, t1/2, and Cl), both in plasma and intracellular, of RAL and ETV.
Measured: baseline and 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2010 (estimated)
- Study startApr 2010
- Primary completionOct 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV-1 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospitales Universitarios Virgen del Rocío
- Sponsor type
- University, hospital or other
- Investigators
- Luis F Lopez-Cortes, ND, PhD, Principal investigator, Hospitales Universitarios Virgen del Rocío
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01121809
- Sponsor's protocol ID
- LLC-RAET-2009-1
- Other IDs
- 2009-014480-39, 2009
- Acronym
- RAET
- Status last verified
- Feb 2011
- First submitted
- 4 May 2010
- Last updated
- 8 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gutierrez-Valencia A, Martin-Pena R, Torres-Cornejo A, Ruiz-Valderas R, Castillo-Ferrando JR, Lopez-Cortes LF. Intracellular and plasma pharmacokinetics of 400 mg of etravirine once daily versus 200 mg of etravirine twice daily in HIV-infected patients. J Antimicrob Chemother. 2012 Mar;67(3):681-4. doi: 10.1093/jac/dkr534. Epub 2011 Dec 21.
PubMed 22190606
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma and Intracellular Concentrations of Raltegravir and Etravirine Administered Once Daily (800 mg and 400 mg, Respectively) Compared With Standard Dosing (400 mg and 200 mg/12 h) in Patients With HIV Infection
- ClinicalTrials.gov ID
- NCT01121809
- Acronym / sponsor ID
- RAET / LLC-RAET-2009-1
- Conditions
- HIV-1 Infection, HIV Infections
- Keywords
- Raltegravir, etravirine, pharmacokinetics, intracellular
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Hospitales Universitarios Virgen del RocíoUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 12 May 2010 (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.
Hypothesis: the intracellular concentrations of raltegravir (RAL) and etravirine (ETV) administrated as 800 and 400 mg once a day, respectively, are similar to those obtained with the standard doses of 400 and 200 mg/12h, respectively.
Objective: To analyze the plasma and intracellular concentrations of RAL and ETV administrated as 800 and 400 mg once daily respectively compared with standard doses of 400 and 200 mg/12h, respectively, and if they support its once daily administration.
Detailed description
Objective: To analyze the plasma and intracellular concentrations of RAL and ETV administrated as 800 and 400 mg once daily respectively compared with standard doses of 400 and 200 mg/12h, respectively, and if they support its once daily administration.
Method: Phase IV, prospective, open labelled clinical trial with a planned duration of 24 weeks in which 16 patients from Hospitales Universitarios Virgen del Rocío will be enrolled. A 12 hours pharmacokinetic profile (immediately before and after 1, 2, 3, 4, 6, 8, 10 and 12 h) will be obtained after a supervised drug intake while taking RAL or ETV bid. Afterwards,the patients will take RAL or ETV once a day for 7 - 10 days. Subsequently, a new pharmacokinetic profile (predose and after 1, 2, 3, 4, 6, 8, 10, 12, 16, 20 and 24 h after a supervised drug intake) will be obtained.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Raltegravir | Other | Drug: RaltegravirRaltegravir 400 mg bid |
| Etravirine | Other | Drug: EtravirineEtravirine 200 mg bid |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult HIV-1-infected patients taking raltegravir- or etravirine-based antiretroviral regimens
Key exclusion criteria (4 listed)
- Pregnancy
- Concomitant use of drugs that have potential interactions with raltegravir or etravirine pharmacokinetics
- Cirrhosis with clinical or analytic data of liver failure.
- Clinical history suggesting malabsorption or presence of diarrhea (> 3 stools / day) that could interfere with the absorption of study drugs.
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 |
|---|---|---|
| RaltegravirChanging the dose of raltegravir from 400 mg bid to 800 mg qd | Drug | Raltegravir |
| EtravirineChanging the dose of etravirine from 200 mg bid to 400 mg qd | Drug | Etravirine |
Primary outcome
Changes in pharmacokinetic parameters (Cmax, Cmin, AUC, t1/2, and Cl), both in plasma and intracellular, of RAL and ETV.
Time frame: baseline and 1 week
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 8 Feb 2011.
- Derived from this study: PubMed 22190606Gutierrez-Valencia A, Martin-Pena R, Torres-Cornejo A, Ruiz-Valderas R, Castillo-Ferrando JR, Lopez-Cortes LF. Intracellular and plasma pharmacokinetics of 400 mg of etravirine once daily versus 200 mg of etravirine twice daily in HIV-infected patients. J Antimicrob Chemother. 2012 Mar;67(3):681-4. doi: 10.1093/jac/dkr534. Epub 2011 Dec 21.
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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.
Luis F Lopez-Cortes, ND, PhD principal investigator
Hospitales Universitarios Virgen del Rocío
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 Raltegravir and Etravirine in people with HIV-1 Infection and HIV Infections, run by Hospitales Universitarios Virgen del Rocío 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 1 inclusion and 4 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 8 Feb 2011. 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?
Changes in pharmacokinetic parameters (Cmax, Cmin, AUC, t1/2, and Cl), both in plasma and intracellular, of RAL and ETV. (time frame: baseline and 1 week). 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 NCT01121809, which also lists 1 linked publication.
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 8 Feb 2011.