HIV InfectionsPhase 4NCT00718536
Clinical Trial Assessing Once Daily Raltegravir Administration (800 mg QD) in HIV-1-Infected Patients Receiving Unboosted Atazanavir (400 mg QD)- Based Antiretroviral Therapy
A Phase 4 study testing Addition of raltegravir 800 mg QD to HAART in people with HIV Infections, run by Germans Trias i Pujol Hospital at 1 site in Spain.
Trial summary
The co-administration of raltegravir with medicinal products that are knouwn to be potent UGT1A1 inhibitors, such as atazanavir, may increase plasma levels of raltegravir. So once daily raltegravir (800 mg QD), instead of twice a day (400 mg BID), could be an appropriate therapeutic option in HIV-infected patients… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Addition of raltegravir 800 mg QD to HAART
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSpain
- Study dates
- Aug 2008to Jan 2009
- 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
- Patients aged 18 to 65 years old with documented HIV-1 infection.
- Patients on antiretroviral regimen that includes atazanavir 400mg QD for at least 4 weeks.
- Complete virological suppression (<50 copies/mL) for at least 12 months.
- Voluntary written informed consent.
- Ability of compliance with visit schedule.
Who cannot join
- AIDS defining condition within 4 weeks prior to the initiation of the study.
- Concomitant treatment with ritonavir as well as with inducers (NNRTI, rifampin, carbamazepine, phenytoin, phenobarbital, valproic acid, etc) or inhibitors (probenecid, etc) of the uridine diphosphate glucuronyl transferase within 2 weeks before the screening visit.
- Concomitant therapy with tenofovir.
- History or suspected poor adherence to HAART.
- History of drug allergy to raltegravir
Trial locations and contacts
1 site in 1 country.
About this study
The co-administration of raltegravir with medicinal products that are knouwn to be potent UGT1A1 inhibitors, such as atazanavir, may increase plasma levels of raltegravir. So once daily raltegravir (800 mg QD), instead of twice a day (400 mg BID), could be an appropriate therapeutic option in HIV-infected patients also receiving atazanavir-containing antiretroviral regimens. In this study, pharmacokinetic data supporting this hypothesis are recovered.
Read the detailed description
Treatment adherence is crucial for the effectiveness of antiretroviral therapy, and, in an attempt to promote treatment adherence by the patients, once daily (QD) regimens are preferred rather than twice daily (BID) regimens.
The dose of 400 mg BID of raltegravir has been recently licensed for the treatment of human immunodeficiency virus (HIV-1) infection in treatment-experienced adult patients.
Raltegravir is eliminated mainly by metabolism via uridine diphosphate glucuronyl transferase (UGT1A1)-mediated glucuronidation pathway. Thus, co-administration of raltegravir with medicinal products that are known to be potent UGT1A1 inhibitors, such as atazanavir, may increase plasma levels of raltegravir.
Based on these data, it could be hypothesized that once daily raltegravir (800 mg QD) could be an appropriate therapeutic option in HIV-infected patients also receiving atazanavir-containing antiretroviral regimens. However, pharmacokinetic data supporting this hypothesis are lacking.
- Conditions
- HIV Infections
- Being tested
- Addition of raltegravir 800 mg QD to HAART
- Keywords
- Atazanavir, Raltegravir, once-daily, pharmacokinetics, HIV
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Addition of raltegravir 800 mg QD to HAARTDrug
Also called HAART+RAL
Addition of raltegravir 800 mg QD to HAART
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Addition of raltegravir 800 mg QD to HAART Receives: Drug: Addition of raltegravir 800 mg QD to HAART |
What is being measured
The primary outcome is the main question the study is designed to answer.
Raltegravir area under the curve (AUC) 24 hours and Cmin
Measured: Day 10
Secondary outcomes (2)
Adverse events
Measured: Baseline (BL), Day 10
Adherence
Measured: BL, Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2008 (estimated)
- Study startAug 2008
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Germans Trias i Pujol Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
- Responsible party
- Sponsor
- Investigators
- Clotet Bonaventura, MD,PhD, Principal investigator, Lluita contra la Sida Foundation, HIV Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00718536
- Sponsor's protocol ID
- RALqd-ATV
- Status last verified
- Dec 2019
- First submitted
- 16 Jul 2008
- Last updated
- 5 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial Assessing Once Daily Raltegravir Administration (800 mg QD) in HIV-1-Infected Patients Receiving Unboosted Atazanavir (400 mg QD)- Based Antiretroviral Therapy
- ClinicalTrials.gov ID
- NCT00718536
- Acronym / sponsor ID
- RALqd-ATV
- Conditions
- HIV Infections
- Keywords
- Atazanavir, Raltegravir, once-daily, pharmacokinetics, HIV
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Germans Trias i Pujol HospitalUniversity, hospital or other
- Collaborators
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
- Study start
- Aug 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 18 Jul 2008 (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 co-administration of raltegravir with medicinal products that are knouwn to be potent UGT1A1 inhibitors, such as atazanavir, may increase plasma levels of raltegravir. So once daily raltegravir (800 mg QD), instead of twice a day (400 mg BID), could be an appropriate therapeutic option in HIV-infected patients also receiving atazanavir-containing antiretroviral regimens. In this study, pharmacokinetic data supporting this hypothesis are recovered.
Detailed description
Treatment adherence is crucial for the effectiveness of antiretroviral therapy, and, in an attempt to promote treatment adherence by the patients, once daily (QD) regimens are preferred rather than twice daily (BID) regimens.
The dose of 400 mg BID of raltegravir has been recently licensed for the treatment of human immunodeficiency virus (HIV-1) infection in treatment-experienced adult patients.
Raltegravir is eliminated mainly by metabolism via uridine diphosphate glucuronyl transferase (UGT1A1)-mediated glucuronidation pathway. Thus, co-administration of raltegravir with medicinal products that are known to be potent UGT1A1 inhibitors, such as atazanavir, may increase plasma levels of raltegravir.
Based on these data, it could be hypothesized that once daily raltegravir (800 mg QD) could be an appropriate therapeutic option in HIV-infected patients also receiving atazanavir-containing antiretroviral regimens. However, pharmacokinetic data supporting this hypothesis are lacking.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Addition of raltegravir 800 mg QD to HAARTAddition of raltegravir 800 mg QD to HAART |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 18 to 65 years old with documented HIV-1 infection.
- Patients on antiretroviral regimen that includes atazanavir 400mg QD for at least 4 weeks.
- Complete virological suppression (<50 copies/mL) for at least 12 months.
- Voluntary written informed consent.
- Ability of compliance with visit schedule.
Key exclusion criteria (5 listed)
- AIDS defining condition within 4 weeks prior to the initiation of the study.
- Concomitant treatment with ritonavir as well as with inducers (NNRTI, rifampin, carbamazepine, phenytoin, phenobarbital, valproic acid, etc) or inhibitors (probenecid, etc) of the uridine diphosphate glucuronyl transferase within 2 weeks before the screening visit.
- Concomitant therapy with tenofovir.
- History or suspected poor adherence to HAART.
- History of drug allergy to raltegravir
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 |
|---|---|---|
| Addition of raltegravir 800 mg QD to HAARTAlso: HAART+RALAddition of raltegravir 800 mg QD to HAART | Drug | 1 |
Primary outcome
Raltegravir area under the curve (AUC) 24 hours and Cmin
Time frame: Day 10
2 secondary outcomes
Adverse events
Time frame: Baseline (BL), Day 10
Adherence
Time frame: BL, Day 10
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 Dec 2019.
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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.
Clotet Bonaventura, MD,PhD principal investigator
Lluita contra la 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 Addition of raltegravir 800 mg QD to HAART in people with HIV Infections, 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 5 inclusion and 5 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 Dec 2019. 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?
Raltegravir area under the curve (AUC) 24 hours and Cmin (time frame: Day 10). 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 5 Dec 2019.