HIV InfectionPhase 2/3DORISSNCT02069834
Dolutegravir + Rilpivirine Switch Study (DORISS)
A Phase 2/3 study testing Arm 1 (intervention) in people with HIV Infection and HAART-treated, run by Nantes University Hospital at 25 sites in France.
Trial summary
The primary objective of the study is to evaluate the capacity of Dolutegravir + Rilpivirine vs. continued triple combination HAART to maintain plasma HIV RNA ≤ 50 copies/ml throughout 24 weeks in patients with plasma HIV RNA ≤ 50 copies/mL for at least 2 years under conventional HAART (2 NNRTI + 3rd agent). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection, HAART-treated, Virologically Controlled
- What is being tested?
- Arm 1 (intervention)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 25 sitesFrance
- Study dates
- May 2014to Oct 2017
- Phase
- Phase 2/3
- 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
- Age ≥ 18 years
- HIV-1 infection
- Treatment with suppressive triple HAART (2 NRTI + either 1 PI/r, or 1 NNRTI, or INI), unchanged for > 6 months, Intra-class substitution within past 6 months is not considered as a treatment change.
- Plasma HIV-RNA ≤ 50 copies/mL for > 2 years
- CD4 cell count > 350/mm3 for > 6 months
- No prior virologic failure under an NNRTI-containing or an INSTI-containing ART regimen
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- No NNRTI mutation on pre-ART genotype (if no pre-ART genotype available: no NNRTI mutation on DNA genotype at screening) among the following: K101E/P, E138A/G/K/Q/R/S, V179L, Y181C/I/V, Y188L, H221Y, M230I/L/V, L100I + K103N/S, L100I +K103R +V179D.
- No mutation (either on pre-ART genotype or on DNA genotype at screening) among the following: T66K, G118R, V151L, S153F/Y, R263K, T66K + L74M, E92Q + N155H, Q148R +N155H, Q148H/K/R with at least one mutation of L74I or E138A/K/T or G140A/C/S
- Negative HBs Ag
- Informed consent form signed by patient and investigator
- A specific consent for the pharmacokinetic substudy will be signed by the 10 patients of the pilot phase of the trial who will be randomized to the Dolutegravir + Rilpivirine arm and will volunteer for this PK study
- Patient covered with health insurance
- Effective contraception
Who cannot join
- HIV-2 infection
- Dialysis or severe renal failure (creatinine clearance < 30 ml/min)
- History of decompensated liver disease
- History of HIV-associated neurocognitive disorders
- AST or ALT > 5 x ULN
- Positive HBc Ac and negative HBs Ac
Show all 10Show fewer
- Patient receiving a proton pump inhibitor that cannot be switched to another anti-secretory drug
- Current pregnancy or breastfeeding
- Patient involved in another research that precludes enrolment in another trial
- Patient under guardianship, or deprived of liberty by a court or administrative decision.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
France25 sites
Chu Jean Minjoz
Besançon, 25030
Hôpital Avicenne
Bobigny, 93000
Hôpital Jean Verdier
Bondy, 93140
CHU de Bordeaux
Bordeaux, 33076
CHU de DIJON
Dijon, 21079
CHU de Fort de France
Fort de France, Martinique, 87261
CHD La Roche sur Yon
La Roche-sur-Yon, 85925
CHU Kremlin Bicêtre
Le Kremlin-Bicêtre, 94275
Hôpital Perpetuel Secours
Levallois-Perret, 92300
CHU de Nantes
Nantes, 44093
CHU Hôtel Dieu Paris
Paris, 75004
Hôpital La Pitié Salpêtrière
Paris, 75013
Hôpital Necker - enfants Malades
Paris, 75015
Hôpital Saint Louis
Paris, 75475
CHU BICHAT - Claude Bernard
Paris, 75877
Hôpital Européen Georges Pompidou
Paris, 75908
CHU Guadeloupe
Point-a-pitre, Guadeloupe, 97159
CHU de Rennes - Hôpital Pontchaillou
Rennes, 35000
CH Delafontaine
Saint-Denis, 93200
CHU Saint Etienne
Saint-Etienne, 42055
CHU de Strasbourg
Strasbourg, 67091
Hôpital FOCH
Suresnes, 92150
CHU Toulouse
Toulouse, 31059
CHRU de Tours
Tours, 37044
CHU de Nancy
Vandœuvre-lès-Nancy, 54511
About this study
Official title: Dolutegravir + Rilpivirine Switch Study (DORISS): Pilot and Noninferiority Trial Comparing Dolutegravir + Rilpivirine vs. Continued HAART (Highly Active Antiretroviral Therapy) in Patients With Plasma HIV RNA ≤ 50 Copies/mL for at Least 2 Years
The primary objective of the study is to evaluate the capacity of Dolutegravir + Rilpivirine vs. continued triple combination HAART to maintain plasma HIV RNA ≤ 50 copies/ml throughout 24 weeks in patients with plasma HIV RNA ≤ 50 copies/mL for at least 2 years under conventional HAART (2 NNRTI + 3rd agent).
The main secondary objectives are the following:
Read more
- % of virologic success (plasma viral load ≤ 50 copies/mL) at W24 and W48
- % of patients who maintain a plasma viral load ≤ 50 copies / ml from D0 to W48
- % of virological failure defined by two consecutive plasma viral load > 50 copies/mL
- Profile of genotypic resistance in case of virological failure.
The trial will be conducted according to the design below, in 3 steps:
- Step 1: enrollment of 80 patients (40 in each arm)
- Step 2: enrollment on hold until W16 data from the 40 patients enrolled in the intervention arm have been analyzed.
- Step 3: resumption and completion of enrollment if conditions for resuming enrollment at the end of step 2 are fulfilled, i.e. if the percentage of patients randomized to the intervention arm who have a plasma viral load ≤ 50 copies/mL from D0 to W16 is significantly > 70%, which translates in a maximum of 6 virologic failures.
- Conditions
- HIV Infection, HAART-treated, Virologically Controlled
- Being tested
- Arm 1 (intervention), Arm 2 (control)
- Keywords
- Dolutegravir, Rilpivirine, PI- and NRTI- sparing ART regimen, switch study
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm 1 (intervention)Drug
Dolutegravir 50 mg/j + Rilpivirine 25 mg/j qd orally (intake during meal)
Arm 2 (control)Drug
Continuation of existing HAART at the time of randomization
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (intervention) | Experimental | Dolutegravir 50 mg/d + Rilpivirine 25 mg/d qd orally (intake during a meal) Receives: Drug: Arm 1 (intervention) |
| Arm 2 (control) | Active comparator | Continuation of existing HAART at the time of randomization Receives: Drug: Arm 2 (control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pilot phase: Percentage of patients with plasma viral load ≤ 50 copies HIV-RNA/ml from D0 (Day 0) to W16 (Week 16)
Measured: Week 16
Non-inferiority phase: Percentage of patients with plasma HIV RNA maintained ≤ 50 copies/mL throughout 24 weeks
Measured: Week 24
Secondary outcomes (24)
Percentage of patients with plasma viral load ≤50 HIV RNA copies/mL at Week 24 and Week 48
Measured: Week 48
Percentage of patients with plasma viral load ≤50 HIV RNA copies/mL from Day 0 to Week 48
Measured: Week 48
Percentage of virologic failure, defined as 2 consecutive plasma HIV RNA > 50 copies/mL
Measured: Week 48
Measure of the profile of genotypic resistance in plasma in case of virologic failure
Measured: Week 48
Percentage of patients who discontinued or changed the strategy of the study
Measured: Week 48
Measure of the HIV-DNA between day 0 and week 48
Evolution of the HIV-DNA between Day 0 and week 48
Measured: W48
Measure of CD4 lymphocytes at week 24 compared to day 0
Evolution of CD4 lymphocytes (average) at Week 24 compared to Day 0
Measured: Week 24
Measure of CD4 lymphocytes at Week 48 compared to Day 0
Evolution of CD4 lymphocytes (average) at Week 48 compared to Day0
Measured: Week 48
Number of patients with adverse events of grade 2 to 4
Adverse events : incidence, grade and relation to study medication of all adverse events, of grade 2 to 4 events
Measured: Week 48
Measure of changes in serum plasma lipid parameters at week 24 compared to Day 0
Mean changes in serum plasma lipid parameters at Week 24 compared to Day 0
Measured: Week 24
Measure of changes in serum lipid parameters at week 48 to Day 0
Mean changes in serum plasma lipid parameters at Week 48 compared to Day 0
Measured: Week 48
Measure of changes in fat mass distribution at week 24 compared to Day 0
Changes in fat mass distribution at Week 24 compared to Day 0
Measured: Week 24
Measure of changes in fat mass distribution at Week 48 compared to Day 0
Changes in fat mass distribution at Week 48 compared to Day 0
Measured: Week 48
Measure of adherence to treatment at Week 24 compared to Day 0
Evolution of adherence to treatment at Week 24 compared to Day 0 assessed by a validated questionnaire
Measured: Week 24
Measure of adherence to treatment at Week 48 compared to Day 0
Evolution of adherence to treatment at Week 48 compared to Day 0 assessed by a validated questionnaire
Measured: Week 48
Measure of patient satisfaction for their treatment at Day 0
Assessment of patient satisfaction for their treatment at D0 by questionnaire
Measured: Day 0
Measure of patient satisfaction for their treatment at Week 24
Assessment of patient satisfaction for their treatment at Week 24 by questionnaire
Measured: Week 24
Measure of patient satisfaction for their treatment at Week 48
Assessment of patient satisfaction for their treatment at Week 48 by questionnaire
Measured: Week 48
Measure of changes in plasma biomarkers of inflammation (hs-CRP and IL-6) and immune activation (sCD14 , MCP -1, IP10 ) at Week 24 compared to Day 0 .
Changes in plasma biomarkers of inflammation (hs-CRP and IL-6) and immune activation (sCD14 , MCP -1, IP10 ) at Week 24 compared to Day 0 .
Measured: Week 24
Measure of changes in plasma biomarkers of inflammation (hs-CRP and IL-6) and immune activation (sCD14 , MCP -1, IP10 ) at Week 48 compared to Day 0 .
Changes in plasma biomarkers of inflammation (hs-CRP and IL-6) and immune activation (sCD14 , MCP -1, IP10 ) at Week 48 compared to Day 0 .
Measured: Week 48
Measure of plasma concentrations of Dolutegravir and Rilpivirine measured at Week 4
Analysis PK (PharmacoKinetic) / PD (Pharmaodynamic) of plasma concentrations of Dolutegravir and Rilpivirine measured at Week 4
Measured: Week 4
Measure of plasma concentrations of Dolutegravir and Rilpivirine measured at Week 24
Analysis PK / PD of plasma concentrations of Dolutegravir and Rilpivirine measured at Week 24
Measured: Week 24
Measure of the profile of genotypic resistance in plasma in case of virologic failure
Measured: Week 24
Percentage of virologic failure, defined as 2 consecutive plasma HIV RNA > 50 copies/mL
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2014 (estimated)
- Study startMay 2014
- Primary completionOct 2017 (estimated)
- Study completionOct 2017 (estimated)
Why it stopped: One of the both Funder partners decided to stop the study before the initiation : thus no product provided and no funding to realize the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02069834
- Sponsor's protocol ID
- RC13_0322
- Other IDs
- 2013-003344-23
- Acronym
- DORISS
- Status last verified
- Aug 2015
- First submitted
- 18 Feb 2014
- Last updated
- 28 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dolutegravir + Rilpivirine Switch Study (DORISS): Pilot and Noninferiority Trial Comparing Dolutegravir + Rilpivirine vs. Continued HAART (Highly Active Antiretroviral Therapy) in Patients With Plasma HIV RNA ≤ 50 Copies/mL for at Least 2 Years
- ClinicalTrials.gov ID
- NCT02069834
- Acronym / sponsor ID
- DORISS / RC13_0322
- Conditions
- HIV Infection, HAART-treated, Virologically Controlled
- Keywords
- Dolutegravir, Rilpivirine, PI- and NRTI- sparing ART regimen, switch study
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: One of the both Funder partners decided to stop the study before the initiation : thus no product provided and no funding to realize the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 24 Feb 2014 (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 primary objective of the study is to evaluate the capacity of Dolutegravir + Rilpivirine vs. continued triple combination HAART to maintain plasma HIV RNA ≤ 50 copies/ml throughout 24 weeks in patients with plasma HIV RNA ≤ 50 copies/mL for at least 2 years under conventional HAART (2 NNRTI + 3rd agent).
The main secondary objectives are the following:
- % of virologic success (plasma viral load ≤ 50 copies/mL) at W24 and W48
- % of patients who maintain a plasma viral load ≤ 50 copies / ml from D0 to W48
- % of virological failure defined by two consecutive plasma viral load > 50 copies/mL
- Profile of genotypic resistance in case of virological failure.
The trial will be conducted according to the design below, in 3 steps:
- Step 1: enrollment of 80 patients (40 in each arm)
- Step 2: enrollment on hold until W16 data from the 40 patients enrolled in the intervention arm have been analyzed.
- Step 3: resumption and completion of enrollment if conditions for resuming enrollment at the end of step 2 are fulfilled, i.e. if the percentage of patients randomized to the intervention arm who have a plasma viral load ≤ 50 copies/mL from D0 to W16 is significantly > 70%, which translates in a maximum of 6 virologic failures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (intervention) | Experimental | Drug: Arm 1 (intervention)Dolutegravir 50 mg/d + Rilpivirine 25 mg/d qd orally (intake during a meal) |
| Arm 2 (control) | Active comparator | Drug: Arm 2 (control)Continuation of existing HAART at the time of randomization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age ≥ 18 years
- HIV-1 infection
- Treatment with suppressive triple HAART (2 NRTI + either 1 PI/r, or 1 NNRTI, or INI), unchanged for > 6 months, Intra-class substitution within past 6 months is not considered as a treatment change.
- Plasma HIV-RNA ≤ 50 copies/mL for > 2 years
- CD4 cell count > 350/mm3 for > 6 months
Key exclusion criteria (10 listed)
- HIV-2 infection
- Dialysis or severe renal failure (creatinine clearance < 30 ml/min)
- History of decompensated liver disease
- History of HIV-associated neurocognitive disorders
- AST or ALT > 5 x ULN
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 |
|---|---|---|
| Arm 1 (intervention)Dolutegravir 50 mg/j + Rilpivirine 25 mg/j qd orally (intake during meal) | Drug | Arm 1 (intervention) |
| Arm 2 (control)Continuation of existing HAART at the time of randomization | Drug | Arm 2 (control) |
Primary outcome
Pilot phase: Percentage of patients with plasma viral load ≤ 50 copies HIV-RNA/ml from D0 (Day 0) to W16 (Week 16)
Time frame: Week 16
Non-inferiority phase: Percentage of patients with plasma HIV RNA maintained ≤ 50 copies/mL throughout 24 weeks
Time frame: Week 24
24 secondary outcomes
Percentage of patients with plasma viral load ≤50 HIV RNA copies/mL at Week 24 and Week 48
Time frame: Week 48
Percentage of patients with plasma viral load ≤50 HIV RNA copies/mL from Day 0 to Week 48
Time frame: Week 48
Percentage of virologic failure, defined as 2 consecutive plasma HIV RNA > 50 copies/mL
Time frame: Week 48
Measure of the profile of genotypic resistance in plasma in case of virologic failure
Time frame: Week 48
Percentage of patients who discontinued or changed the strategy of the study
Time frame: Week 48
Measure of the HIV-DNA between day 0 and week 48
Time frame: W48
Measure of CD4 lymphocytes at week 24 compared to day 0
Time frame: Week 24
Measure of CD4 lymphocytes at Week 48 compared to Day 0
Time frame: Week 48
Number of patients with adverse events of grade 2 to 4
Time frame: Week 48
Measure of changes in serum plasma lipid parameters at week 24 compared to Day 0
Time frame: Week 24
Measure of changes in serum lipid parameters at week 48 to Day 0
Time frame: Week 48
Measure of changes in fat mass distribution at week 24 compared to Day 0
Time frame: Week 24
Measure of changes in fat mass distribution at Week 48 compared to Day 0
Time frame: Week 48
Measure of adherence to treatment at Week 24 compared to Day 0
Time frame: Week 24
Measure of adherence to treatment at Week 48 compared to Day 0
Time frame: Week 48
Measure of patient satisfaction for their treatment at Day 0
Time frame: Day 0
Measure of patient satisfaction for their treatment at Week 24
Time frame: Week 24
Measure of patient satisfaction for their treatment at Week 48
Time frame: Week 48
Measure of changes in plasma biomarkers of inflammation (hs-CRP and IL-6) and immune activation (sCD14 , MCP -1, IP10 ) at Week 24 compared to Day 0 .
Time frame: Week 24
Measure of changes in plasma biomarkers of inflammation (hs-CRP and IL-6) and immune activation (sCD14 , MCP -1, IP10 ) at Week 48 compared to Day 0 .
Time frame: Week 48
Measure of plasma concentrations of Dolutegravir and Rilpivirine measured at Week 4
Time frame: Week 4
Measure of plasma concentrations of Dolutegravir and Rilpivirine measured at Week 24
Time frame: Week 24
Measure of the profile of genotypic resistance in plasma in case of virologic failure
Time frame: Week 24
Percentage of virologic failure, defined as 2 consecutive plasma HIV RNA > 50 copies/mL
Time frame: Week 24
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Arm 1 (intervention) in people with HIV Infection and HAART-treated, run by Nantes University Hospital at 25 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 13 inclusion and 10 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: withdrawn, as of the sponsor's last update on 28 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Pilot phase: Percentage of patients with plasma viral load ≤ 50 copies HIV-RNA/ml from D0 (Day 0) to W16 (Week 16) (time frame: Week 16). The study lists 2 primary outcomes in all. 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 28 Aug 2015; AzTrials last refreshed its copy on 29 Oct 2026.