Status:
UNKNOWN
Reducing Antiretroviral Treatments
Lead Sponsor:
ANRS, Emerging Infectious Diseases
Collaborating Sponsors:
Institut National de la Santé Et de la Recherche Médicale, France
Conditions:
HIV-1-infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this trial is to demonstrate at W48 the non-inferiority of a dual nucleoside analogues strategy with tenofovir (TDF) or tenofovir alafenamide (TAF) plus emtricitabine (FTC) or lamivudin...
Detailed Description
ANRS 173 ALTAR is a multicenter, comparative, international, open label, phase III randomized trial aiming at evaluating the non-inferiority of a TRI-BI (tritherapy-bitherapy) strategy (includes a 16 ...
Eligibility Criteria
Inclusion
- Documented HIV-1 infection (positive HIV-1 serology or plasma viral load)
- Age ≥ 18 years
- Therapeutic antiretroviral treatment-naive participant (history of prophylaxy is accepted)
- CD4 cells count \> 300 cells/mm3 at screening visit
- HIV-1-RNA plasma viral load \<50 000 copies/mL at screening visit
- Full susceptibility to trial drugs (NRTI, INI) at screening visit
- eGFR (epidermal growth factor receptor) \> 60 mL /min (MDRD)
- AST (aspartate aminotransferase), ALT(alanine transaminase) \< 3x norm
- Absence of any AIDS-defining event and/or opportunistic infection
- Possible contact by phone and/or email in order to be informed in case of detectable HIV plasma viral load
- Negative urinary pregnancy test at screening visit for women of childbearing age
- Written and informed consent signed
- For French participants only: subject enrolled in or a beneficiary of a Social Security programme (including State Medical Aid (AME), only if Ethic Committee approves it)
Exclusion
- HIV-2 co-infection
- Hepatitis B Virus infection (positive HBs antigen)
- Any comorbidity potentially related to a life expectancy below 12 months
- Any condition (use of alcohol, drugs, etc.) judged by the investigator to possibly interfere with trial protocol compliance, adherence and/or trial treatment tolerance
- Pregnant women or breastfeeding women
- Women of childbearing age that do not want to use an effective method of contraception
- Participant under justice protection
- Galactose/lactose intolerance, Lapp lactase deficiency or glucose/galactose malabsorption (known or documented)
- Participation to another clinical trial evaluating a new treatment/therapy
Key Trial Info
Start Date :
November 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2024
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT04051970
Start Date
November 27 2019
End Date
March 1 2024
Last Update
August 9 2021
Active Locations (1)
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1
Hôpital la Salpêtrière
Paris, France