Status:
UNKNOWN
ANRS 12372 MODERATO Study
Lead Sponsor:
ANRS, Emerging Infectious Diseases
Collaborating Sponsors:
Mylan Laboratories
Conditions:
HIV-1-infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
MODERATO is a phase III, open-label, randomized, multicenter, non-inferiority trial conducted in West and Central Africa (Cameroon, Côte d'Ivoire, Burkina Faso). HIV-1 infected adults receiving first...
Detailed Description
In HIV-1 infected adults receiving first line ART with TDF+XTC+EFV or DTG+XTC+TDF virologically suppressed (viral load \< detection limit of the technique used) for at least two years: to assess the n...
Eligibility Criteria
Inclusion
- HIV-1 infection
- 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
- HIV-2 infection or HIV-1+2 infection
- 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
Key Trial Info
Start Date :
September 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 5 2025
Estimated Enrollment :
480 Patients enrolled
Trial Details
Trial ID
NCT04022967
Start Date
September 21 2020
End Date
February 5 2025
Last Update
September 6 2023
Active Locations (5)
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1
Hôpital de jour, Service des maladies infectieuses, CHU Sourô Sanou
Bobo-Dioulasso, Burkina Faso
2
Service de médecine interne, CHU Yalgado Ouédraogo
Ouagadougou, Burkina Faso
3
Service des Maladies Infectieuses, Hôpital du jour, Hôpital Central
Yaoundé, Cameroon
4
Centre de Prise en Charge et de Formation (CePReF), Association ACONDA
Abidjan, Côte d’Ivoire