HIV InfectionsPhase 4ODISNCT00941083
Simplification From Protease Inhibitors to Raltegravir
A Phase 4 study testing Raltegravir (Use RAL as a simplification strategy) in people with HIV Infections, run by Hospital Carlos III, Madrid at 1 site in Spain.
Trial summary
A switch from protease inhibitors (PIs) to raltegravir (RAL) will be effective virologically and immunologically. Moreover, it will be associated with significant improvements in the lipid profile in HIV patients with undetectable viremia on PIs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Raltegravir (Use RAL as a simplification strategy)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2009to Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV1 sero-positive using standard diagnostic criteria
- Plasma viral HIV-RNA below 50 copies/ml within 180 days prior to randomization
- On therapy with protease inhibitors both ritonavir-boosted or un-boosted for at least 6 months prior to study entry
Who cannot join
- Pregnancy or breast feeding
- Prior use of Integrase inhibitors
- Alcohol or substance abuse if according to the investigator opinion would interfere with compliance
- UIse of investigational medications within 30 days before study entry or during the trial
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Carlos III
Madrid, Madrid, 28029
Vicente Soriano, PhD, +34914532536, vsoriano@dragonet.es
Vicente Soriano, PhD
About this study
Official title: Pilot, Open-label, Randomized, Single-center Study to Asses a Simplification Strategy From Protease Inhibitors to Raltegravir: Once Daily Isentress (ODIS)
A switch from protease inhibitors (PIs) to raltegravir (RAL) will be effective virologically and immunologically. Moreover, it will be associated with significant improvements in the lipid profile in HIV patients with undetectable viremia on PIs. In this setting, RAL once a day (QD) will perform as well as RAL twice a day (BID).
- Conditions
- HIV Infections
- Being tested
- Raltegravir (Use RAL as a simplification strategy)
- Keywords
- Simplification from protease inhibitors to raltegravir, Treatment Experienced, HIV-1 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.
Raltegravir (Use RAL as a simplification strategy)Drug
RAL QD: RAL 800 mg/24 hs
Raltegravir (Use RAL as a simplification strategy)Drug
RAL BID 400 mg/12 hs
Raltegravir (Use RAL as a simplification strategy)Drug
RAL BID to QD
| Study group | Role | What they receive |
|---|---|---|
| RAL QD 800 mg/24 hs | Experimental | Not described Receives: Drug: Raltegravir (Use RAL as a simplification strategy) |
| RAL BID 400 mg/12 hs | Active comparator | Not described Receives: Drug: Raltegravir (Use RAL as a simplification strategy) |
| RAL BID to QD | Experimental | Not described Receives: Drug: Raltegravir (Use RAL as a simplification strategy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with plasma HIV-RNA < 50 copies/ml at week 24 in each arm (RAL QD, RAL BID, RAL BID to QD)
Measured: 24 weeks
Secondary outcomes (3)
CD4 gains, lipid profile, adverse events,
Measured: 24 weeks
Drug resistance mutations
Measured: 24 weeks
Raltegravir through plasma levels and correlation with virological failure
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2009 (estimated)
- Study completionDec 2009 (estimated)
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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Carlos III, Madrid
- Sponsor type
- University, hospital or other
- Investigators
- Vicente Soriano, Dr, Principal investigator, Hospital Carlos III
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00941083
- Sponsor's protocol ID
- HC0509
- Acronym
- ODIS
- Status last verified
- Sep 2009
- First submitted
- 14 Jul 2009
- Last updated
- 10 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Vispo E, Barreiro P, Maida I, Mena A, Blanco F, Rodriguez-Novoa S, Morello J, Jimenez-Nacher I, Gonzalez-Lahoz J, Soriano V. Simplification from protease inhibitors to once- or twice-daily raltegravir: the ODIS trial. HIV Clin Trials. 2010 Jul-Aug;11(4):197-204. doi: 10.1310/hct1104-197.
PubMed 20974575
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot, Open-label, Randomized, Single-center Study to Asses a Simplification Strategy From Protease Inhibitors to Raltegravir: Once Daily Isentress (ODIS)
- ClinicalTrials.gov ID
- NCT00941083
- Acronym / sponsor ID
- ODIS / HC0509
- Conditions
- HIV Infections
- Keywords
- Simplification from protease inhibitors to raltegravir, Treatment Experienced, HIV-1 Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Hospital Carlos III, MadridUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 17 Jul 2009 (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.
A switch from protease inhibitors (PIs) to raltegravir (RAL) will be effective virologically and immunologically. Moreover, it will be associated with significant improvements in the lipid profile in HIV patients with undetectable viremia on PIs. In this setting, RAL once a day (QD) will perform as well as RAL twice a day (BID).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RAL QD 800 mg/24 hs | Experimental | Drug: Raltegravir (Use RAL as a simplification strategy) |
| RAL BID 400 mg/12 hs | Active comparator | Drug: Raltegravir (Use RAL as a simplification strategy) |
| RAL BID to QD | Experimental | Drug: Raltegravir (Use RAL as a simplification strategy) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- HIV1 sero-positive using standard diagnostic criteria
- Plasma viral HIV-RNA below 50 copies/ml within 180 days prior to randomization
- On therapy with protease inhibitors both ritonavir-boosted or un-boosted for at least 6 months prior to study entry
Key exclusion criteria (4 listed)
- Pregnancy or breast feeding
- Prior use of Integrase inhibitors
- Alcohol or substance abuse if according to the investigator opinion would interfere with compliance
- UIse of investigational medications within 30 days before study entry or during the trial
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 |
|---|---|---|
| Raltegravir (Use RAL as a simplification strategy)RAL QD: RAL 800 mg/24 hs | Drug | RAL QD 800 mg/24 hs |
| Raltegravir (Use RAL as a simplification strategy)RAL BID 400 mg/12 hs | Drug | RAL BID 400 mg/12 hs |
| Raltegravir (Use RAL as a simplification strategy)RAL BID to QD | Drug | RAL BID to QD |
Primary outcome
Proportion of patients with plasma HIV-RNA < 50 copies/ml at week 24 in each arm (RAL QD, RAL BID, RAL BID to QD)
Time frame: 24 weeks
3 secondary outcomes
CD4 gains, lipid profile, adverse events,
Time frame: 24 weeks
Drug resistance mutations
Time frame: 24 weeks
Raltegravir through plasma levels and correlation with virological failure
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2009.
- Derived from this study: PubMed 20974575Vispo E, Barreiro P, Maida I, Mena A, Blanco F, Rodriguez-Novoa S, Morello J, Jimenez-Nacher I, Gonzalez-Lahoz J, Soriano V. Simplification from protease inhibitors to once- or twice-daily raltegravir: the ODIS trial. HIV Clin Trials. 2010 Jul-Aug;11(4):197-204. doi: 10.1310/hct1104-197.
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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.
Vicente Soriano, Dr principal investigator
Hospital Carlos III
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 (Use RAL as a simplification strategy) in people with HIV Infections, run by Hospital Carlos III, Madrid 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 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: status not confirmed, as of the sponsor's last update on 10 Sep 2009. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with plasma HIV-RNA < 50 copies/ml at week 24 in each arm (RAL QD, RAL BID, RAL BID to QD) (time frame: 24 weeks). 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 NCT00941083, 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 10 Sep 2009.