HIVPhase 3TRULIGHTNCT02302547
Trial to Evaluate the Interest of a Reductive Anti Retroviral Strategy Using Dual Therapy Inspite of Triple Therapy
A Phase 3 study testing triple therapy and dual therapy in people with HIV, run by University Hospital, Tours at 16 sites in France.
Trial summary
In the early 2000s, the "TRILEGE©" study was realized to determine if the reductive anti retroviral strategy from an initial triple therapy (based on a protease inhibitor as the third agent) towards a dual therapy of nucleoside analogs (in particular the association of "zidovudine +lamivudine") for patients infected… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- triple therapy and dual therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 16 sitesFrance
- Study dates
- Dec 2014to 21 Sep 2018
- 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 patient
- Initial TT ARV started above (or equal to) 150 / mm3 LT CD4, and 18 months prior to inclusion in the study
- Ongoing antiretroviral therapy combining tenofovir + emtricitabine + a 3rd agent (IP / r, IP, NNRTI, II, Inhibitors) with at least one undetectable viral load (CV <50 copies / mL) after introduction of the latter treatment.
- Patient in virological success: CV <50 copies / mL for at least 12 months, including visit to selection.
- Absence of previous therapeutic failure: no viral load ≥ 200 copies / mL (after 6 months of treatment) (Except in the case of a justified therapeutic interruption: travel, stock-out ...) and of obtaining success Virologic after introduction of treatment, without concept of genotypic resistance known to the ARVs used.
- Cellular DNA-HIV <2.7 log copies / 106 PBMC
Show all 11Show fewer
- Zenith RNA-HIV <150,000 copies / ml (excluding viral load values during primary infection if it is documented)
- No genotypic resistance to currently used and known ARVs
- Patient who has given written informed consent
- Affiliate or beneficiary of a social security scheme
- Patient followed on an outpatient basis, age ≥ 18 years.
Who cannot join
- Non-compliant patient
- Subject is pregnant, or lactating, or of childbearing potential and without contraception
- Active opportunistic infections
- Major overweight (BMI ≥ 40)
- Severe renal pathology (creatinine clearance < 30ml/min)
- Cirrhosis or severe liver failure (factor V < 50%)
Show all 14Show fewer
- Prognosis threatened within 6 months
- Circumstances that may impair judgment or understanding of the information given to the patient
- Malabsorption syndromes
- The following laboratory criteria:
- Serum ASAT,ALAT > 5 x upper limit of normal (ULN)
- Thrombocytopenia with platelet count < 50.000/ml
- Anemia with hemoglobin < 8g/dl
- Polynuclear neutrophil count < 500/mm3
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
France16 sites
Unité des Maladies Infectieuses, CHU de CAEN
Caen, 14033
Service des Maladies Infectieuses, CHR Orléans La Source, ORLEANS CEDEX 2
CHR d'ORLEANS, 45067
Service d'Immunologie Clinique centre de Vaccination anti- VIH ANRS Hopital Henri- Mondor
Créteil, 94010
Service de Médecine Interne et Maladies Infectieuses, Groupe Hospitalier La Rochelle, Cedex 01
La Rochelle, 17019
Service de Pneumologie, centre Hospitalier Fontenoy, CH de CHARTRES
Le Coudray, 28630
CHU de NANCY
Nancy, 54035
Service des maladies Infectieuses et tropicales, CH GEORGES RENON
Niort, 79021
Service des Maladies Infectieuses et tropicales, APHP SAINT LOUIS
Paris, 75475
Hospital Tenon
Paris, 75970
Centre de diagnostic et thérapeutique, Hopital Hotel Dieu
Paris, 94010
Consultation Maladies Infectieuses, Chu de Poitiers, Cedex
Poitiers, 86021
Maladies Infectieuses, CHU de ROUEN
Rouen, 76031
Service de Médecine Interne, CH de SAINTONGE- BP 326
Saintes, 17108
Médecine Interne, Hôpital FOCH
Suresnes, 92151
Service Universitaire des Maladies Infectieuses et du Voyageur, CH DRON
Tourcoing, 59200
Service de Medecine Interne et Maladies Infectieuses, CHRU BRETONNEAU, TOURS CEDEX9
Tours, 37044
About this study
Official title: Randomized Clinical Trial to Evaluate the Interest of a Down-scaled Treatment Strategy Using Dual Therapy (Nucleoside Analogs) in HIV Infected Patients Already Being Treated Using Triple Therapy, Who Present With a Successful Virological Control and for Which the HIV Reservoir is Low to Moderate
In the early 2000s, the "TRILEGE©" study was realized to determine if the reductive anti retroviral strategy from an initial triple therapy (based on a protease inhibitor as the third agent) towards a dual therapy of nucleoside analogs (in particular the association of "zidovudine +lamivudine") for patients infected by HIV and stabilized for at least 3 months at a threshold value of 400 copies/ml, would allow to obtain a well-controlled plasmatic viral load, with an aim to reduce the long-term side effects of the treatment.
The afore mentioned study showed that the reductive anti retroviral strategy was a failure. No study has as yet to revaluate this strategy, in particular in the current context of antiretroviral treatments.
Read more
Indeed, modern nucleoside inhibitors (Kivexa®, Truvada®) have extended half-lives as well as a superior intrinsic power as compared to treatments proposed in the initial "TRILEGE©" study. Furthermore, the better quality of current triple therapy (as compared to that used 10 years ago) has lead to substantial viral reservoir reduction.
Currently, a small number of patients is being successfully treated in the long-term (viral load < 20 copies/ml) using nucleoside analog dual therapy. The particular characteristics of these patients have yet to be thoroughly investigated.
The patients concerned were all treated prematurely before ever passing below 200 lymphocytes T CD4/mm3. It occurred that all these patients presented a low viral reservoir as measured by HIV DNA quantification (< 2,7 log copies/106 PBMC).
Therefore, by targeting patients who have (1) a strong immune restoration, (2) a low HIV DNA value and (3) a very good observance, the investigators emit the hypothesis that, reductive anti retroviral strategy that would consist in changing from a conventional triple therapy towards a Nucleoside reverse-transcriptase inhibitors dual therapy, could allow for durable control of viral replication with the concomitant benefice of reduced antiretroviral side effects and cost.
- Conditions
- HIV
- Being tested
- triple therapy, dual therapy
- Keywords
- HIV-DNA, dual therapy, NRTI, virological control, truvada®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
triple therapyDrug
Also called Tenofovir+Emtricitabine+Third agent (Including a non nucleoside reverse transcriptase inhibitor: efavirenz or nevirapine or etravirine or rilpivirine, Tenofovir+Emtricitabine+Third agent (Including a ritonavir-boosted protease inhibitor : saquinavir or indinavir or fosamprenavir or tipranavir or darunavir or atazanavir or lopinavir, Tenofovir+Emtricitabine+Third agent (Including an unboosted protease inhibitor: atazanavir or indinavir, Tenofovir+Emtricitabine+Third agent (Including an integrase inhibitor raltegravir or dolutegravir or cobicistat-boosted elvitegravir
Dosage treatment and usual prescription
dual therapyDrug
Also called Truvada®
1 tablet (200mg/245mg) daily for 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| triple therapy | Active comparator | Tenofovir Disoproxil Fumarate (nucleotide reverse transcriptase inhibitor) + Emtricitabine (nucleoside reverse transcriptase inhibitor) + third agent (boosted protease inhibitor or unboosted protease inhibitor or integrase inhibitor or celsentri or non-nucleoside reverse transcriptase inhibitor). Receives: Drug: triple therapy |
| dual therapy | Experimental | Truvada®"245mg":oral administration Tenofovir Disoproxil Fumarate (nucleotide reverse transcriptase inhibitor) + Emtricitabine (nucleoside reverse transcriptase inhibitor) Receives: Drug: dual therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral Load at 48 weeks
Percentage of patient having a viral load < 50 copies/ml in each arm reductive anti retroviral strategy from an original backbone of 2 Nucleoside reverse transcriptase inhibitors (Tenofovir Disoproxil Fumarate+ Emtricitabine) coupled to a third agent, towards a therapeutic strategy containing the backbone therapy alone (Truvada®).
Measured: 48 weeks
Secondary outcomes (4)
Change from week 4 in Viral load at 48 weeks
percentage of patients having a viral load between 50 and 400 copies/ml between week 4 and week 48
Measured: between 4 weeks and 48 weeks
CD 4 level in each arm
delta CD 4 measurement in each arm
Measured: 48 weeks
Change from day 0 in HIV - DNA at week 48
HIV DNA evolution between day 0 and week 48 in each arm
Measured: day 0 and 48 weeks
RNA and DNA viral load (sub study)
RNA and DNA viral load in the genital tract (cervico-vaginal secretions or sperm): comparison between arms
Measured: Time Frame: Week 24 to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2014 (estimated)
- Study startDec 2014
- Primary completion23 Aug 2017
- Study completion21 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Collaborators
- HOSPITAL, ORLEANS, Poitiers University Hospital, Centre Hospitalier de La Rochelle, HOSPITAL, SAINTES, HOSPITAL, FOCH, HOSPITAL, CAEN, Henri Mondor University Hospital, Hotel Dieu Hospital, HOSPITAL, CHARTRES, HOSPITAL, SAINT LOUIS, Tourcoing Hospital, Central Hospital, NIORT, Tenon Hospital, Paris, Central Hospital, Nancy, France, University Hospital, Rouen
- Responsible party
- Sponsor
- Investigators
- LOUIS BERNARD, Pr, Principal investigator, CHRU de TOURSGWENAEL LE MOAL, Dr, Principal investigator, Poitiers University HospitalMARIAM RONCATO- SABERAN, Dr, Principal investigator, CH de LA ROCHELLETHIERRY PASDELOUPS, Dr, Principal investigator, CH de SAINTESDAVID ZUCMAN, Dr, Principal investigator, HOPITAL de FOCHRENAUD VERDON, Pr, Principal investigator, University Hospital, CaenSEBASTIEN GALLIEN, Pr, Principal investigator, CHU d'HENRI MONDORJEAN - PAUL VIARD, Pr, Principal investigator, CH d'HOTEL DIEU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02302547
- Sponsor's protocol ID
- PHAO13-TP/TRULIGHT
- Acronym
- TRULIGHT
- Status last verified
- Nov 2018
- First submitted
- 14 Oct 2014
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Prazuck T, Verdon R, Le Moal G, Ajana F, Bernard L, Sunder S, Roncato-Saberan M, Ponscarme D, Etienne M, Viard JP, Pasdeloup T, Darasteanu I, Pialoux G, de la Blanchardiere A, Avettand-Fenoel V, Parienti JJ, Hocqueloux L; TRULIGHT Study Team. Tenofovir disoproxil fumarate and emtricitabine maintenance strategy in virologically controlled adults with low HIV-1 DNA: 48 week results from a randomized, open-label, non-inferiority trial. J Antimicrob Chemother. 2021 May 12;76(6):1564-1572. doi: 10.1093/jac/dkab038.
PubMed 33724373Hocqueloux L, Gubavu C, Prazuck T, De Dieuleveult B, Guinard J, Seve A, Mille C, Gardiennet E, Lopez P, Rouzioux C, Lefeuvre S, Avettand-Fenoel V. Genital Human Immunodeficiency Virus-1 RNA and DNA Shedding in Virologically Suppressed Individuals Switching From Triple- to Dual- or Monotherapy: Pooled Results From 2 Randomized, Controlled Trials. Clin Infect Dis. 2020 Apr 15;70(9):1973-1979. doi: 10.1093/cid/ciz511.
PubMed 31350995
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial to Evaluate the Interest of a Down-scaled Treatment Strategy Using Dual Therapy (Nucleoside Analogs) in HIV Infected Patients Already Being Treated Using Triple Therapy, Who Present With a Successful Virological Control and for Which the HIV Reservoir is Low to Moderate
- ClinicalTrials.gov ID
- NCT02302547
- Acronym / sponsor ID
- TRULIGHT / PHAO13-TP/TRULIGHT
- Conditions
- HIV
- Keywords
- HIV-DNA, dual therapy, NRTI, virological control, truvada®
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Collaborators
- HOSPITAL, ORLEANS, Poitiers University Hospital, Centre Hospitalier de La Rochelle, HOSPITAL, SAINTES, HOSPITAL, FOCH, HOSPITAL, CAEN, Henri Mondor University Hospital, Hotel Dieu Hospital, HOSPITAL, CHARTRES, HOSPITAL, SAINT LOUIS, Tourcoing Hospital, Central Hospital, NIORT, Tenon Hospital, Paris, Central Hospital, Nancy, France, University Hospital, Rouen
- Study start
- Dec 2014 (actual)
- Primary completion
- 23 Aug 2017 (actual)
- Study completion
- 21 Sep 2018 (actual)
- First posted
- 27 Nov 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.
In the early 2000s, the "TRILEGE©" study was realized to determine if the reductive anti retroviral strategy from an initial triple therapy (based on a protease inhibitor as the third agent) towards a dual therapy of nucleoside analogs (in particular the association of "zidovudine +lamivudine") for patients infected by HIV and stabilized for at least 3 months at a threshold value of 400 copies/ml, would allow to obtain a well-controlled plasmatic viral load, with an aim to reduce the long-term side effects of the treatment.
The afore mentioned study showed that the reductive anti retroviral strategy was a failure. No study has as yet to revaluate this strategy, in particular in the current context of antiretroviral treatments.
Indeed, modern nucleoside inhibitors (Kivexa®, Truvada®) have extended half-lives as well as a superior intrinsic power as compared to treatments proposed in the initial "TRILEGE©" study. Furthermore, the better quality of current triple therapy (as compared to that used 10 years ago) has lead to substantial viral reservoir reduction.
Currently, a small number of patients is being successfully treated in the long-term (viral load < 20 copies/ml) using nucleoside analog dual therapy. The particular characteristics of these patients have yet to be thoroughly investigated.
The patients concerned were all treated prematurely before ever passing below 200 lymphocytes T CD4/mm3. It occurred that all these patients presented a low viral reservoir as measured by HIV DNA quantification (< 2,7 log copies/106 PBMC).
Therefore, by targeting patients who have (1) a strong immune restoration, (2) a low HIV DNA value and (3) a very good observance, the investigators emit the hypothesis that, reductive anti retroviral strategy that would consist in changing from a conventional triple therapy towards a Nucleoside reverse-transcriptase inhibitors dual therapy, could allow for durable control of viral replication with the concomitant benefice of reduced antiretroviral side effects and cost.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| triple therapy | Active comparator | Drug: triple therapyTenofovir Disoproxil Fumarate (nucleotide reverse transcriptase inhibitor) + Emtricitabine (nucleoside reverse transcriptase inhibitor) + third agent (boosted protease inhibitor or unboosted protease inhibitor or integrase inhibitor or celsentri or non-nucleoside reverse transcriptase inhibitor). |
| dual therapy | Experimental | Drug: dual therapyTruvada®"245mg":oral administration Tenofovir Disoproxil Fumarate (nucleotide reverse transcriptase inhibitor) + Emtricitabine (nucleoside reverse transcriptase inhibitor) |
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 patient
- Initial TT ARV started above (or equal to) 150 / mm3 LT CD4, and 18 months prior to inclusion in the study
- Ongoing antiretroviral therapy combining tenofovir + emtricitabine + a 3rd agent (IP / r, IP, NNRTI, II, Inhibitors) with at least one undetectable viral load (CV <50 copies / mL) after introduction of the latter treatment.
- Patient in virological success: CV <50 copies / mL for at least 12 months, including visit to selection.
- Absence of previous therapeutic failure: no viral load ≥ 200 copies / mL (after 6 months of treatment) (Except in the case of a justified therapeutic interruption: travel, stock-out ...) and of obtaining success Virologic after introduction of treatment, without concept of genotypic resistance known to the ARVs used.
Key exclusion criteria (14 listed)
- Non-compliant patient
- Subject is pregnant, or lactating, or of childbearing potential and without contraception
- Active opportunistic infections
- Major overweight (BMI ≥ 40)
- Severe renal pathology (creatinine clearance < 30ml/min)
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 |
|---|---|---|
| triple therapyAlso: Tenofovir+Emtricitabine+Third agent (Including a non nucleoside reverse transcriptase inhibitor: efavirenz or nevirapine or etravirine or rilpivirine, Tenofovir+Emtricitabine+Third agent (Including a ritonavir-boosted protease inhibitor : saquinavir or indinavir or fosamprenavir or tipranavir or darunavir or atazanavir or lopinavir, Tenofovir+Emtricitabine+Third agent (Including an unboosted protease inhibitor: atazanavir or indinavir, Tenofovir+Emtricitabine+Third agent (Including an integrase inhibitor raltegravir or dolutegravir or cobicistat-boosted elvitegravirDosage treatment and usual prescription | Drug | triple therapy |
| dual therapyAlso: Truvada®1 tablet (200mg/245mg) daily for 48 weeks | Drug | dual therapy |
Primary outcome
Viral Load at 48 weeks
Time frame: 48 weeks
Percentage of patient having a viral load < 50 copies/ml in each arm reductive anti retroviral strategy from an original backbone of 2 Nucleoside reverse transcriptase inhibitors (Tenofovir Disoproxil Fumarate+ Emtricitabine) coupled to a third agent, towards a therapeutic strategy containing the backbone therapy alone (Truvada®).
4 secondary outcomes
Change from week 4 in Viral load at 48 weeks
Time frame: between 4 weeks and 48 weeks
CD 4 level in each arm
Time frame: 48 weeks
Change from day 0 in HIV - DNA at week 48
Time frame: day 0 and 48 weeks
RNA and DNA viral load (sub study)
Time frame: Time Frame: Week 24 to 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 26 Dec 2025.
- Background: PubMed 33724373Prazuck T, Verdon R, Le Moal G, Ajana F, Bernard L, Sunder S, Roncato-Saberan M, Ponscarme D, Etienne M, Viard JP, Pasdeloup T, Darasteanu I, Pialoux G, de la Blanchardiere A, Avettand-Fenoel V, Parienti JJ, Hocqueloux L; TRULIGHT Study Team. Tenofovir disoproxil fumarate and emtricitabine maintenance strategy in virologically controlled adults with low HIV-1 DNA: 48 week results from a randomized, open-label, non-inferiority trial. J Antimicrob Chemother. 2021 May 12;76(6):1564-1572. doi: 10.1093/jac/dkab038.
- Derived from this study: PubMed 31350995Hocqueloux L, Gubavu C, Prazuck T, De Dieuleveult B, Guinard J, Seve A, Mille C, Gardiennet E, Lopez P, Rouzioux C, Lefeuvre S, Avettand-Fenoel V. Genital Human Immunodeficiency Virus-1 RNA and DNA Shedding in Virologically Suppressed Individuals Switching From Triple- to Dual- or Monotherapy: Pooled Results From 2 Randomized, Controlled Trials. Clin Infect Dis. 2020 Apr 15;70(9):1973-1979. doi: 10.1093/cid/ciz511.
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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.
LOUIS BERNARD, Pr principal investigator
CHRU de TOURS
GWENAEL LE MOAL, Dr principal investigator
Poitiers University Hospital
MARIAM RONCATO- SABERAN, Dr principal investigator
CH de LA ROCHELLE
16 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 triple therapy and dual therapy in people with HIV, run by University Hospital, Tours at 16 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 14 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 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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?
Viral Load at 48 weeks (time frame: 48 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 NCT02302547, which also lists 2 linked publications.
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 26 Dec 2025.