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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UNKNOWN
PHASE3
480 participants
INTERVENTIONAL
2020-09-21
2025-02-05
Brief Summary
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HIV-1 infected adults receiving first line ART with TDF+XTC+EFV or DTG+XTC+TDF virologically suppressed will be recruited and followed during 100 weeks.
The objective is to assess the non-inferiority of a strategy consisting of switching to a dual maintenance therapy (DTG+3TC or ATV/r+3TC), comparing to WHO standard first line regimen (TDF+3TC+EFV or DTG+3TC+TDF), in terms of virological success at 96 weeks
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Detailed Description
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This is a trial including two strategies (dual maintenance therapy and triple reference therapy) and three ART regimens (DTG+3TC and ATV/r+3TC used in the maintenance strategy and TDF+3TC+EFV/ DTG+3TC+TDF used in the reference strategy).
The primary analysis will compare the two strategies. Secondary analyses will compare the three ART regimens two by two.
In order to make these secondary analyses possible, participants will be randomly assigned, at inclusion, to each of the three ART regimens (arm 1: DTG+3TC; arm 2: ATV/r+3TC; arm 3: TDF+3TC+EFV / DTG+3TC+TDF). The maintenance strategy will include arm 1 and 2. The reference strategy will include arm 3
Number of participants : 480 (160 in each ART regimen, ie 320 in the dual maintenance therapy strategy and 160 in the triple therapy reference strategy)
The primary endpoint is treatment success, as defined by using the FDA snapshot algorithm : patients who are still continuing the assigned strategy and whose last available plasma HIV-1 RNA in the the window analysis (90 to 102 weeks) is \<50 copies/ml at the end of the window analysis (90 to 102 weeks)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1 : Dual maintenance therapy DTG+3TC
dolutegravir
One daily tablet (50mg) during 96 weeks
Lamivudine
One daily tablet (300mg) during 96 weeks
Arm 2 : Dual maintenance therapy ATV/r+3TC
atazanavir boosted with ritonavir
One daily tablet with atazanavir (300 mg) boosted with ritonavir (100 mg) during 96 weeks
Lamivudine
One daily tablet (300mg) during 96 weeks
Arm 3 : Reference triple therapy TDF+3TC+EFV or DTG+3TC+TDF
tenofovir + lamivudine +efavirenz or dolutegravir + lamivudine + tenofovir
One daily tablet with tenofovir 245 mg + lamivudine (300 mg) + efavirenz (400 mg) during 96 weeks OR One daily tablet with dolutegravir 50 mg + lamivudine (300 mg) + tenofovir (300 mg) during 96 weeks
Interventions
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dolutegravir
One daily tablet (50mg) during 96 weeks
atazanavir boosted with ritonavir
One daily tablet with atazanavir (300 mg) boosted with ritonavir (100 mg) during 96 weeks
tenofovir + lamivudine +efavirenz or dolutegravir + lamivudine + tenofovir
One daily tablet with tenofovir 245 mg + lamivudine (300 mg) + efavirenz (400 mg) during 96 weeks OR One daily tablet with dolutegravir 50 mg + lamivudine (300 mg) + tenofovir (300 mg) during 96 weeks
Lamivudine
One daily tablet (300mg) during 96 weeks
Eligibility Criteria
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Inclusion Criteria
* Age of legal majority
* CD4 \> 200 cells/mm3 at pre-inclusion
* Start first-line ART with non-nucleotide reverse transcriptase inhibitors including TDF+XTC+EFV for at least two years without a past history of virological failure, OR
* Be on TDF+XTC+EFV for at least two years then DTG+XTC+TDF without a past history of virological failure, OR
* Be on DTG+XTC+TDF (1st line regimen) for at least two years without a past history of virological failure
* Absence of past history of virological failure (viral load above the threshold corresponding to the test used); two blips between 50 and 200 copies/ml are allowed.
* At least 2 consecutive HIV-1 RNA \< 50 copies/ml within past 2 years, including HIV-1 RNA at pre-inclusion
* Women with pregnancy potential are required to use an effective contraceptive method throughout the study follow up.
* Signed informed consent
Exclusion Criteria
* CD4 nadir \<100 cells/mm3
* Chronic Hepatitis B (HBs Ag positive in the pre-inclusion balance)
* Ongoing active Tuberculosis
* Ongoing severe opportunistic infection
* Ongoing chemotherapy or immunotherapy
* Grade \> 2 hemoglobin, neutrophil or platelet disorder
* ALT≥ 3 times the upper limit of normal value
* Creatinine clearance \< 50 ml/min (CKD-EPI)
* Allergy to a trial drugs or drug component
* Ongoing pregnancy or Refusal of contraception
* Patient at risk of non-compliance
* Ongoing treatment with a drug that should not be associated with one of the drugs used in the study (cf appendix E page 77)
* Any symptoms or biological findings suggestive of a systemic disorder (renal, hepatic, cardiovascular, pulmonary) or other medical conditions that may interfere with the interpretation of test results or jeopardize the health of patients
18 Years
ALL
No
Sponsors
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Mylan Laboratories
INDUSTRY
ANRS, Emerging Infectious Diseases
OTHER_GOV
Responsible Party
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Principal Investigators
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Serge P. Eholié, MD, MSc, Pr
Role: PRINCIPAL_INVESTIGATOR
Service des Maladies Infectieuses et Tropicales, CHU de Treichville, Abidjan, Côte d'Ivoire
Roland Landman, MD
Role: PRINCIPAL_INVESTIGATOR
Institut de Médecine et d'Epidémiologie Appliquée - Hôpital Bichat Claude Bernard, Paris, France
Xavier Anglaret, MD, PhD
Role: STUDY_DIRECTOR
Inserm 1219, Université de Bordeaux, France
Pierre-Marie Girard, MD, PhD
Role: STUDY_CHAIR
Infectious Diseases Department, University Hospital Saint Antoine, Paris, France
Locations
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Hôpital de jour, Service des maladies infectieuses, CHU Sourô Sanou
Bobo-Dioulasso, , Burkina Faso
Service de médecine interne, CHU Yalgado Ouédraogo
Ouagadougou, , Burkina Faso
Service des Maladies Infectieuses, Hôpital du jour, Hôpital Central
Yaoundé, , Cameroon
Centre de Prise en Charge et de Formation (CePReF), Association ACONDA
Abidjan, , Côte d’Ivoire
Service des Maladies Infectieuses et Tropicales (SMIT), CHU de Treichville
Abidjan, , Côte d’Ivoire
Countries
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Related Links
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Sponsor site
Related Info
Other Identifiers
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ANRS 12372 MODERATO
Identifier Type: -
Identifier Source: org_study_id
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