HIV INFECTIONPhase 2DARULIGHTNCT02384967
Evaluation of a Dose Reduction of Darunavir (400 mg/d) in Virologically Suppressed HIV-1 Patients
A Phase 2 study testing Darunavir in people with HIV INFECTION, run by ANRS, Emerging Infectious Diseases at 1 site in France.
Trial summary
Phase II trial assessing the efficacy of a reduced dose strategy of darunavir to 400 mg/d in HIV-1 infected patients virologically suppressed under a once daily regimen including darunavir 800 mg/d and two nucleoside reverse transcriptase inhibitors (NRTI), to maintain the viral load lower than 50 copies / mL at 48… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV INFECTION
- What is being tested?
- Darunavir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2015to Oct 2016
- Phase
- Phase 2
- 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 adults,
- age ≥ 18 years,
- with a once-a-day ritonavir-boosted darunavir 800mg/j containing regimen plus 2 NRTI (≥ 6 months),
- virologically controlled (VL ≤ 50 cp/ml,
- ≥ 1 year,
- at least 2 VL spaced at least 3 months apart in the last 12 months) CD4 count ≥ 300/mm3 ≥ 6 months,
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- virus sensible to darunavir and the used NRTI (pretreatment resistance genotypic test available) and
- with no history of virological failure (VL > 200 cp/mL after ≥ 6 months under PI and/or used NRTI),
- no current opportunistic infection,
- renal clearance ≥ 60 mL/min if tenofovir is used,
- transaminases (SGOT, SGPT) plasma levels < 2N,
- hemoglobin > 11 g/dL,
- platelets count > 150 000/mm3,
- negative pregnancy test in women with childbearing potential,
- informed written consent signed by both the investigator and the subject,
- national insurance scheme (article L1121-11 of the French Public Health code),
- no participation to any other clinical trial
Who cannot join
- HIV-2 infection,
- current antiretroviral therapy different from a once-a-day ritonavir-boosted darunavir 800mg/j containing regimen plus 2 NRTI,
- virus genotypically resistant to darunavir and the used NRTIs,
- history of virological failure (VL > 200 cp/mL after ≥ 6 months under PI and/or used NRTI),
- irregular follow-up and/or history of lack of adherence to ART ≤ 12 months,
- current pregnancy,
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- current opportunistic infection,
- associated treatment containing one or more drugs interacting with hepatic cytochromes,
- any addictive behaviors (alcohol consumption, drugs …) likely to jeopardize the safety of the treatment and / or patient compliance and adherence to the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Trial Assessing the Efficacy of a Reduced Dose Strategy of Darunavir to 400 mg/d in HIV-1 Infected Patients Virologically Suppressed Under a Once Daily Regimen Including Darunavir 800 mg/d and Two Nucleoside Reverse Transcriptase Inhibitors (NRTI), to Maintain the Viral Load Lower Than 50 Copies / mL at 48 Weeks of Treatment
Phase II trial assessing the efficacy of a reduced dose strategy of darunavir to 400 mg/d in HIV-1 infected patients virologically suppressed under a once daily regimen including darunavir 800 mg/d and two nucleoside reverse transcriptase inhibitors (NRTI), to maintain the viral load lower than 50 copies / mL at 48 weeks of treatment.
Read the detailed description
Principal objective: To evaluate the proportion of subjects virologically suppressed at week 48 (viral load=VL ≤ 50 cp/mL) under a tri-therapy containing the darunavir at the dose of 400 mg/d.
Secondary objectives: To evaluate between baseline and week 48: proportions of subjects: in virological failure (confirmed VL > 50 cp/mL) confirmed by a 2nd measure made between 2 to 4 weeks, with VL ≤ 50 cp/mL and between 20 and 50 cp/mL, emerging drug resistance if virological failure, CD4 cell count evolution, HIV DNA evolution, morphological and glucido-lipid parameters modifications, digestive treatment tolerance , adherence to treatment, overall cost of antiretroviral therapy, factors associated to virological failure including baseline and nadir CD4 cell count, darunavir plasma level, baseline HIV DNA viral load.
- Conditions
- HIV INFECTION
- Being tested
- Darunavir
- 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
Also called Prezista
to assess efficacy of a reduced dose strategy of darunavir to 400 mg/d in HIV-1 infected patients virologically suppressed under a once daily regimen including darunavir 800 mg/d and two nucleoside reverse transcriptase inhibitors (NRTI), to maintain the viral load lower than 50 copies / mL at 48 weeks of treatment.
| Study group | Role | What they receive |
|---|---|---|
| Darunavir 400mg/d | Experimental | Tri-therapy containing Darunavir at dose of 400 mg/d. Receives: Drug: Darunavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with therapeutic success, defined as no virological failure
Virological failure is defined as confirmed VL > 50 cp/mL and no change of the strategy
Measured: Week 48
Secondary outcomes (10)
Proportions of patients with virological failure (confirmed VL > 50 cp/ml)
Measured: Week 48
Proportions of patients with VL < 50 cp/ml
Measured: Week 12, Week 24, Week 36, Week 48
Proportions of patients with VL between 20 and 50 cp/ml
Measured: Week 12, Week 24, Week 36, Week 48
Change from baseline in blood CD4 cell count at week 12, week 24, week 36 and week 48
Measured: Week 12, Week 24, Week 36, Week 48
Change from baseline in blood HIV DNA at week 48
Measured: Week 48
Emerging drug resistance if virological failure
Measured: Week 48
Treatment adherence
Measured: Week 48
Change from baseline in blood lipids at week 24 and week 48
Measured: Week 24 and Week 48
Change from baseline in glucose at week 24 and week 48
Measured: Week 24 and Week 48
Treatment Digestive tolerance
Measured: Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionOct 2016
- Study completionOct 2016
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 INFECTIONStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02384967
- Sponsor's protocol ID
- ANRS 165 DARULIGHT
- Other IDs
- 2014-001505-40, 2014
- Acronym
- DARULIGHT
- Status last verified
- Jan 2017
- First submitted
- 23 Feb 2015
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Le MP, Chaix ML, Chevret S, Bertrand J, Raffi F, Gallien S, El Abbassi EMB, Katlama C, Delobel P, Yazdanpanah Y, Saillard J, Molina JM, Peytavin G; ANRS 165 DARULIGHT Study Group. Pharmacokinetic modelling of darunavir/ritonavir dose reduction (800/100 to 400/100 mg once daily) in a darunavir/ritonavir-containing regimen in virologically suppressed HIV-infected patients: ANRS 165 DARULIGHT sub-study. J Antimicrob Chemother. 2018 Aug 1;73(8):2120-2128. doi: 10.1093/jac/dky193.
PubMed 29905808
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial Assessing the Efficacy of a Reduced Dose Strategy of Darunavir to 400 mg/d in HIV-1 Infected Patients Virologically Suppressed Under a Once Daily Regimen Including Darunavir 800 mg/d and Two Nucleoside Reverse Transcriptase Inhibitors (NRTI), to Maintain the Viral Load Lower Than 50 Copies / mL at 48 Weeks of Treatment
- ClinicalTrials.gov ID
- NCT02384967
- Acronym / sponsor ID
- DARULIGHT / ANRS 165 DARULIGHT
- Conditions
- HIV INFECTION
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Study start
- Mar 2015 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 10 Mar 2015 (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.
Phase II trial assessing the efficacy of a reduced dose strategy of darunavir to 400 mg/d in HIV-1 infected patients virologically suppressed under a once daily regimen including darunavir 800 mg/d and two nucleoside reverse transcriptase inhibitors (NRTI), to maintain the viral load lower than 50 copies / mL at 48 weeks of treatment.
Detailed description
Principal objective: To evaluate the proportion of subjects virologically suppressed at week 48 (viral load=VL ≤ 50 cp/mL) under a tri-therapy containing the darunavir at the dose of 400 mg/d.
Secondary objectives: To evaluate between baseline and week 48: proportions of subjects: in virological failure (confirmed VL > 50 cp/mL) confirmed by a 2nd measure made between 2 to 4 weeks, with VL ≤ 50 cp/mL and between 20 and 50 cp/mL, emerging drug resistance if virological failure, CD4 cell count evolution, HIV DNA evolution, morphological and glucido-lipid parameters modifications, digestive treatment tolerance , adherence to treatment, overall cost of antiretroviral therapy, factors associated to virological failure including baseline and nadir CD4 cell count, darunavir plasma level, baseline HIV DNA viral load.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Darunavir 400mg/d | Experimental | Drug: DarunavirTri-therapy containing Darunavir at dose of 400 mg/d. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- HIV-1 infected adults,
- age ≥ 18 years,
- with a once-a-day ritonavir-boosted darunavir 800mg/j containing regimen plus 2 NRTI (≥ 6 months),
- virologically controlled (VL ≤ 50 cp/ml,
- ≥ 1 year,
Key exclusion criteria (9 listed)
- HIV-2 infection,
- current antiretroviral therapy different from a once-a-day ritonavir-boosted darunavir 800mg/j containing regimen plus 2 NRTI,
- virus genotypically resistant to darunavir and the used NRTIs,
- history of virological failure (VL > 200 cp/mL after ≥ 6 months under PI and/or used NRTI),
- irregular follow-up and/or history of lack of adherence to ART ≤ 12 months,
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 |
|---|---|---|
| DarunavirAlso: Prezistato assess efficacy of a reduced dose strategy of darunavir to 400 mg/d in HIV-1 infected patients virologically suppressed under a once daily regimen including darunavir 800 mg/d and two nucleoside reverse transcriptase inhibitors (NRTI), to maintain the viral load lower than 50 copies / mL at 48 weeks of treatment. | Drug | Darunavir 400mg/d |
Primary outcome
Proportion of patients with therapeutic success, defined as no virological failure
Time frame: Week 48
Virological failure is defined as confirmed VL > 50 cp/mL and no change of the strategy
10 secondary outcomes
Proportions of patients with virological failure (confirmed VL > 50 cp/ml)
Time frame: Week 48
Proportions of patients with VL < 50 cp/ml
Time frame: Week 12, Week 24, Week 36, Week 48
Proportions of patients with VL between 20 and 50 cp/ml
Time frame: Week 12, Week 24, Week 36, Week 48
Change from baseline in blood CD4 cell count at week 12, week 24, week 36 and week 48
Time frame: Week 12, Week 24, Week 36, Week 48
Change from baseline in blood HIV DNA at week 48
Time frame: Week 48
Emerging drug resistance if virological failure
Time frame: Week 48
Treatment adherence
Time frame: Week 48
Change from baseline in blood lipids at week 24 and week 48
Time frame: Week 24 and Week 48
Change from baseline in glucose at week 24 and week 48
Time frame: Week 24 and Week 48
Treatment Digestive tolerance
Time frame: Week 48
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 3 Apr 2026.
- Derived from this study: PubMed 29905808Le MP, Chaix ML, Chevret S, Bertrand J, Raffi F, Gallien S, El Abbassi EMB, Katlama C, Delobel P, Yazdanpanah Y, Saillard J, Molina JM, Peytavin G; ANRS 165 DARULIGHT Study Group. Pharmacokinetic modelling of darunavir/ritonavir dose reduction (800/100 to 400/100 mg once daily) in a darunavir/ritonavir-containing regimen in virologically suppressed HIV-infected patients: ANRS 165 DARULIGHT sub-study. J Antimicrob Chemother. 2018 Aug 1;73(8):2120-2128. doi: 10.1093/jac/dky193.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Darunavir in people with HIV INFECTION, run by ANRS, Emerging Infectious Diseases at 1 site 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 17 inclusion and 9 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 3 Apr 2026. 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 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Proportion of patients with therapeutic success, defined as no virological failure (time frame: Week 48). 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 NCT02384967, 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 3 Apr 2026.