Trial to Evaluate the Interest of a Reductive Anti Retroviral Strategy Using Dual Therapy Inspite of Triple Therapy
NCT ID: NCT02302547
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
224 participants
INTERVENTIONAL
2014-12-31
2018-09-21
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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triple therapy
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).
triple therapy
Dosage treatment and usual prescription
dual therapy
Truvada®"245mg":oral administration Tenofovir Disoproxil Fumarate (nucleotide reverse transcriptase inhibitor) + Emtricitabine (nucleoside reverse transcriptase inhibitor)
dual therapy
1 tablet (200mg/245mg) daily for 48 weeks
Interventions
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triple therapy
Dosage treatment and usual prescription
dual therapy
1 tablet (200mg/245mg) daily for 48 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
Exclusion Criteria
* 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%)
* 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
18 Years
ALL
No
Sponsors
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HOSPITAL, ORLEANS
UNKNOWN
Poitiers University Hospital
OTHER
Centre Hospitalier de La Rochelle
OTHER
HOSPITAL, SAINTES
UNKNOWN
HOSPITAL, FOCH
UNKNOWN
HOSPITAL, CAEN
UNKNOWN
Henri Mondor University Hospital
OTHER
HOSPITAL, HOTEL DIEU
UNKNOWN
HOSPITAL, CHARTRES
UNKNOWN
HOSPITAL, SAINT LOUIS
UNKNOWN
Tourcoing Hospital
OTHER
Central Hospital, NIORT
UNKNOWN
Tenon Hospital, Paris
OTHER
Central Hospital, Nancy, France
OTHER
University Hospital, Rouen
OTHER
University Hospital, Tours
OTHER
Responsible Party
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Principal Investigators
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LOUIS BERNARD, Pr
Role: PRINCIPAL_INVESTIGATOR
CHRU de TOURS
GWENAEL LE MOAL, Dr
Role: PRINCIPAL_INVESTIGATOR
Poitiers University Hospital
MARIAM RONCATO- SABERAN, Dr
Role: PRINCIPAL_INVESTIGATOR
CH de LA ROCHELLE
THIERRY PASDELOUPS, Dr
Role: PRINCIPAL_INVESTIGATOR
CH de SAINTES
DAVID ZUCMAN, Dr
Role: PRINCIPAL_INVESTIGATOR
HOPITAL de FOCH
RENAUD VERDON, Pr
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Caen
SEBASTIEN GALLIEN, Pr
Role: PRINCIPAL_INVESTIGATOR
CHU d'HENRI MONDOR
JEAN - PAUL VIARD, Pr
Role: PRINCIPAL_INVESTIGATOR
CH d'HOTEL DIEU
MARC LESTELLE, Dr
Role: PRINCIPAL_INVESTIGATOR
CH de CHARTRES
JEAN - MICHEL MOLINA, Pr
Role: PRINCIPAL_INVESTIGATOR
CHU SAINT LOUIS
FAÏZA AJANA, Dr
Role: PRINCIPAL_INVESTIGATOR
CH de TOURCOING
SIMON SUNDER, Dr
Role: PRINCIPAL_INVESTIGATOR
CH de NIORT
Gilles PIALOUX, Pr
Role: PRINCIPAL_INVESTIGATOR
HOSPITAL TENON
Thierry MAY, Dr
Role: PRINCIPAL_INVESTIGATOR
Central Hospital, Nancy, France
Manuel ETIENNE, Dr
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Rouen
Locations
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Unité des Maladies Infectieuses, CHU de CAEN
Caen, , France
Service des Maladies Infectieuses, CHR Orléans La Source, ORLEANS CEDEX 2
CHR d'ORLEANS, , France
Service d'Immunologie Clinique centre de Vaccination anti- VIH ANRS Hopital Henri- Mondor
Créteil, , France
Service de Médecine Interne et Maladies Infectieuses, Groupe Hospitalier La Rochelle, Cedex 01
La Rochelle, , France
Service de Pneumologie, centre Hospitalier Fontenoy, CH de CHARTRES
Le Coudray, , France
CHU de NANCY
Nancy, , France
Service des maladies Infectieuses et tropicales, CH GEORGES RENON
Niort, , France
Service des Maladies Infectieuses et tropicales, APHP SAINT LOUIS
Paris, , France
Hospital Tenon
Paris, , France
Centre de diagnostic et thérapeutique, Hopital Hotel Dieu
Paris, , France
Consultation Maladies Infectieuses, Chu de Poitiers, Cedex
Poitiers, , France
Maladies Infectieuses, CHU de ROUEN
Rouen, , France
Service de Médecine Interne, CH de SAINTONGE- BP 326
Saintes, , France
Médecine Interne, Hôpital FOCH
Suresnes, , France
Service Universitaire des Maladies Infectieuses et du Voyageur, CH DRON
Tourcoing, , France
Service de Medecine Interne et Maladies Infectieuses, CHRU BRETONNEAU, TOURS CEDEX9
Tours, , France
Countries
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References
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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.
Hocqueloux 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.
Other Identifiers
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PHAO13-TP/TRULIGHT
Identifier Type: -
Identifier Source: org_study_id