Status:
COMPLETED
Trial to Evaluate the Interest of a Reductive Anti Retroviral Strategy Using Dual Therapy Inspite of Triple Therapy
Lead Sponsor:
University Hospital, Tours
Collaborating Sponsors:
HOSPITAL, ORLEANS
Poitiers University Hospital
Conditions:
HIV
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
- 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%)
- 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
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 21 2018
Estimated Enrollment :
224 Patients enrolled
Trial Details
Trial ID
NCT02302547
Start Date
December 1 2014
End Date
September 21 2018
Last Update
December 26 2025
Active Locations (16)
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1
Unité des Maladies Infectieuses, CHU de CAEN
Caen, France, 14033
2
Service des Maladies Infectieuses, CHR Orléans La Source, ORLEANS CEDEX 2
CHR d'ORLEANS, France, 45067
3
Service d'Immunologie Clinique centre de Vaccination anti- VIH ANRS Hopital Henri- Mondor
Créteil, France, 94010
4
Service de Médecine Interne et Maladies Infectieuses, Groupe Hospitalier La Rochelle, Cedex 01
La Rochelle, France, 17019