HIV-1 InfectionPhase 3RADARNCT00849160
Study of Protease Inhibitor Regimen Switch in HIV-1 Infected Patients With Undetectable Viral Load to Prove the Non-inferiority of Once Daily Dose Regimen Versus the Current Twice Daily Regimen to Maintain the Viral Load Under the Limit of Detection.
A Phase 3 study testing darunavir in people with HIV-1 Infection and HIV Infections, run by Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida at 5 sites in France.
Trial summary
Darunavir boosted with ritonavir (darunavir/r) is a powerful protease inhibitor, able to reduce the viral load in patients infected with multi-resistant HIV strains; In vitro and in vivo studies have shown that the induction of resistance mutations in the protease gene is much more difficult with the association… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1 Infection, HIV Infections
- What is being tested?
- darunavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 5 sitesFrance
- Study dates
- May 2009to Sep 2011
- Phase
- Phase 3
- 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
- HIV-1 infected patients
- Treatment with an association of 3 molecules including two Nucleotidic Reverse Trasncriptase Inhibitors and a ritonavir-boosted protease inhibitor BID, unchanged for at least one month
- At least two documented undetectable viral loads (under 50 copies/ml) within the last 3 months
- Naiive from darunavir
- Free from any opportunistic infection
- Creatinin < 3N
Show all 11Show fewer
- ASAT \& ALAT < 5N
- Haemoglobin > 7 g/dl
- Platelets > 50 000/mm3
- Negative pregnancy test for women of childbearing potential and use of a mechanic contraceptive during sexual relationships
- Signed informed consent
Who cannot join
- HIV-2 infected patients
- Treatment different from the association described in the inclusion criteria (2 NRTIs + 1 PI/r BID)
- Patients with a documented problem of treatment compliance within the last 12 months
- Ongoing active treatment against any opportunistic infection or tuberculosis
- Any critic concomitant condition (alcohol consumption, fatigue) that may jeopardize treatment compliance and/olr tolerance, and interfere with the protocol compliance
- Any concomitant treatment that may potentialize or inhibit hepatic cyotchrome-based enzymes
- Patient already treated with darunavir
- Patient treated with tipranavir, enfuvirtide, raltegravir, etravirine, and/or maraviroc
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Centre Hospitalier Universitaire de Bicêtre - Service de Médecine Interne et Maladies Tropicales
Le Kremlin-Bicêtre, 94275
Groupe Hospitalier Pitié-Salpêtrière - Service de Médecine Interne
Paris, 75013
Groupe Hospitalier Pitié-Salpêtrière - Service des Maladies Infectieuses et Tropicales
Paris, 75013
Hôpital Necker Enfants Malades - Service des Maladies Infectieuses et Tropicales
Paris, 75015
Hôpital Tenon - Service des Maladies Infectieuses et Tropicales
Paris, 75020
About this study
Official title: Non-comparative, Opened Study, Evaluating in HIV-1 Infected Patients With Undetectable Viral Load, Treated by an Antiretroviral Combination Including a Protease Inhibitor Boosted With Ritonavir and Administered by Oral Route Twice a Day, the Substitutability of the Current Protease Inhibitor Regimen by the Association Darunavir/Ritonavir 800/100 mg Once a Day to Maintain the Viral Load Under the 50 Copies/ml Limit of Detection After 24 Weeks of Treatment.
Darunavir boosted with ritonavir (darunavir/r) is a powerful protease inhibitor, able to reduce the viral load in patients infected with multi-resistant HIV strains; In vitro and in vivo studies have shown that the induction of resistance mutations in the protease gene is much more difficult with the association darunavir/r compared to the other ritonavir-boosted protease inhibitors (PI/r), testifying of a significantly higher genetic barrier to resistance. Moreover, the tolerance to darunavir is good, and the pharmacologic profile of this molecule allows a once daily administration with a 800/100 mg dose in patients infected with a wild HIV strain or with a slightly resistant to darunavir/r strain.
Thus, we propose to evaluate the efficacy of the darunavir/r association once daily as a substitute to a protease inhibitor regimen administered twice daily in patients with undetectable viral load receiving a tritherapy including a protease inhibitor administered twice daily.
- Conditions
- HIV-1 Infection, HIV Infections
- Being tested
- darunavir
- Keywords
- Treatment Experienced
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
darunavirDrug
darunavir/r 800/100 mg once daily by oral route, 48 weeks of treatment
| Study group | Role | What they receive |
|---|---|---|
| Darunavir/r | Experimental | Not described Receives: Drug: darunavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Undetectable viral load ( < 50 copies/ml)
Measured: Week 24
Secondary outcomes (8)
Proportion of patients with undetectable viral load under 50 copies/ml
Measured: All visits
Proportion of patients in the situation of virologic failure defined as a viral load higher than 50 copies/ml confirmed with a second examen at least two weeks later.
Measured: All visits
CD4 lymphocytes count and evolution
Measured: All visits
Lipids balance evolution
Measured: All visits
Treatment tolerance
Measured: All visits
Measure of the darunavir/r concentrations variability and correlation with the potential adverse events and/or virologic failures.
Measured: All visits
Spermatic viral load (sub-study concerning 15 patients)
Measured: Day 0 and Week 48
Pharmacologic sub-studies
Measured: All visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2009 (estimated)
- Study startMay 2009
- Primary completionJun 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jade Ghosn, MD, Principal investigator, Centre Hsopitalier Universitaire de BicêtreChristine Katlama, MD, Study director, Groupe Hospitalier Pitie-Salpetriere
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00849160
- Sponsor's protocol ID
- CREPATS 001
- Acronym
- RADAR
- Status last verified
- Jan 2014
- First submitted
- 20 Feb 2009
- Last updated
- 22 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-comparative, Opened Study, Evaluating in HIV-1 Infected Patients With Undetectable Viral Load, Treated by an Antiretroviral Combination Including a Protease Inhibitor Boosted With Ritonavir and Administered by Oral Route Twice a Day, the Substitutability of the Current Protease Inhibitor Regimen by the Association Darunavir/Ritonavir 800/100 mg Once a Day to Maintain the Viral Load Under the 50 Copies/ml Limit of Detection After 24 Weeks of Treatment.
- ClinicalTrials.gov ID
- NCT00849160
- Acronym / sponsor ID
- RADAR / CREPATS 001
- Conditions
- HIV-1 Infection, HIV Infections
- Keywords
- Treatment Experienced
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centre de Recherches et d'Etude sur la Pathologie Tropicale et le SidaUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 23 Feb 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.
Darunavir boosted with ritonavir (darunavir/r) is a powerful protease inhibitor, able to reduce the viral load in patients infected with multi-resistant HIV strains; In vitro and in vivo studies have shown that the induction of resistance mutations in the protease gene is much more difficult with the association darunavir/r compared to the other ritonavir-boosted protease inhibitors (PI/r), testifying of a significantly higher genetic barrier to resistance. Moreover, the tolerance to darunavir is good, and the pharmacologic profile of this molecule allows a once daily administration with a 800/100 mg dose in patients infected with a wild HIV strain or with a slightly resistant to darunavir/r strain.
Thus, we propose to evaluate the efficacy of the darunavir/r association once daily as a substitute to a protease inhibitor regimen administered twice daily in patients with undetectable viral load receiving a tritherapy including a protease inhibitor administered twice daily.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Darunavir/r | Experimental | Drug: darunavir |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- HIV-1 infected patients
- Treatment with an association of 3 molecules including two Nucleotidic Reverse Trasncriptase Inhibitors and a ritonavir-boosted protease inhibitor BID, unchanged for at least one month
- At least two documented undetectable viral loads (under 50 copies/ml) within the last 3 months
- Naiive from darunavir
- Free from any opportunistic infection
Key exclusion criteria (8 listed)
- HIV-2 infected patients
- Treatment different from the association described in the inclusion criteria (2 NRTIs + 1 PI/r BID)
- Patients with a documented problem of treatment compliance within the last 12 months
- Ongoing active treatment against any opportunistic infection or tuberculosis
- Any critic concomitant condition (alcohol consumption, fatigue) that may jeopardize treatment compliance and/olr tolerance, and interfere with the protocol compliance
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 |
|---|---|---|
| darunavirdarunavir/r 800/100 mg once daily by oral route, 48 weeks of treatment | Drug | Darunavir/r |
Primary outcome
Undetectable viral load ( < 50 copies/ml)
Time frame: Week 24
8 secondary outcomes
Proportion of patients with undetectable viral load under 50 copies/ml
Time frame: All visits
Proportion of patients in the situation of virologic failure defined as a viral load higher than 50 copies/ml confirmed with a second examen at least two weeks later.
Time frame: All visits
CD4 lymphocytes count and evolution
Time frame: All visits
Lipids balance evolution
Time frame: All visits
Treatment tolerance
Time frame: All visits
Measure of the darunavir/r concentrations variability and correlation with the potential adverse events and/or virologic failures.
Time frame: All visits
Spermatic viral load (sub-study concerning 15 patients)
Time frame: Day 0 and Week 48
Pharmacologic sub-studies
Time frame: All visits
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 22 Jan 2014.
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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.
Jade Ghosn, MD principal investigator
Centre Hsopitalier Universitaire de Bicêtre
Christine Katlama, MD study director
Groupe Hospitalier Pitie-Salpetriere
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing darunavir in people with HIV-1 Infection and HIV Infections, run by Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida at 5 sites 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 11 inclusion and 8 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 22 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Undetectable viral load ( < 50 copies/ml) (time frame: Week 24). 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 22 Jan 2014.