Evaluation of the Efficacy and Safety Between Two Antiretroviral Regimens, in HIV-1-infected Treatment-naïve Subjects With Low CD4 Counts

NCT01928407 | Completed Phase 4 DMC

• 1 other identifier: IMEA 040-DATA
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 30

Brief Summary

A phase IV, prospective, multicenter , randomized open label, 48 weeks study to evaluate the antiretroviral efficacy and safety of atazanavir/ritonavir or darunavir/ritonavir, each in combination with a fixed dose of tenofovir disoproxil fumarate- emtricitabine in HIV-1-infected treatment-naïve subjects with CD4 counts below 200 µL.

Conditions

HIV-1 Infection; Immunosuppression-related Infectious Disease

Keywords

naives, CD4 < 200 cell/mm3, Atazanavir, Darunavir

Outcome Measures

Primary Outcomes (1)

• Viral load of HIV-1 < 50 cp/ml

  To evaluate the virological efficacy and safety at week 48 of 2 regimens atazanavir/ritonavir (ATZ/r) 300/100 mg or darunavir/ritonavir (DRV/r) 800/100 mg, each in combination with a fixed-dose of tenofovir/emtracitabine in HIV-1 treatment-naïve subjects with CD4 counts below 200 µL

  48 weeks

Secondary Outcomes (12)

• • Proportion of subjets with virologic efficacy

  24 weeks

• • Proportion of subjects with confirmed virologic failure

  24 weeks

• Viral lod of HIV-1 on seminal fluid

  W00,W4 et W48

• Immunologic response

  W-4,W2,W4,W12,W24 and W48

• Differenciation and activation of lymphocytes

  W0,W2,W4,W12,W24 and W48

Study Arms (2)

ATAZANAVIR

EXPERIMENTAL

The patient included in this Group 1 will receive their first antiretroviral regimen included : ATV + TDF/FTC (or Abacavir/Lamivudine, \[ABC/3TC\], if contre indicated of TDF/FTC) The dose : atazanavir/ritonavir 300/100mg/day and TDF/FTC 245 /200 mg day, 3 pills once a day, during 48 weeks during a meal

Drug: ATAZANAVIR

DARUNAVIR

EXPERIMENTAL

The patients included in this Group 2 will receive their first antiretroviral regimen included Group 2 : DRV+ TDF/FTC (or ABC/3TC if contre-indicated of TDF/FTC) The dose : darunavir/ritonavir 800/100mg/day and TDF/FTC 245 /200 mg day, 4 pills once a day, during 48 weeks during a meal

Drug: DARUNAVIR

Interventions

DARUNAVIR DRUG

The patient included will receive their first antiretroviral regimen included the darunavir treatment in combination with 2 others molecules

Also known as: Prezista

DARUNAVIR

ATAZANAVIR DRUG

The patient included will receive their first antiretroviral regimen included the atazanavir treatment in combination with 2 others molecules

Also known as: REYATAZ

ATAZANAVIR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, aged \> 18 years of age
• HIV-1 infection determined by a positive ELISA and confirmed by Western blot
• Plasma HIV-RNA \> 1 000 c/mL
• CD4+T cell count \< =200 cells/mm3 at the time of screening, or \< =250 cells/mm3 if the CD4 count was \<200 cells/mm3 12 weeks before screening
• Women of childbearing potential must agree to use an effective method of barrier contraception or have documented sterility
• Subjects must have medical insurance throught the Securite Sociale
• Ability to understand and provide written informed consent

You may not qualify if:

• Acute opportunistic infection within the past two weeks
• HIV-2 infection
• Pregnant woman
• Any subject with drug resistance mutations at screening
• Any subject with a grade 3 or greater clinical or laboratory adverse event at screening
• Any subject who has received antiretoviral therapy except for prevention of mother to child transmission and patients who has received post exposure prophylaxis for a a month or less
• Calculated creatinine clearance \< 60/mL as estimated by the Cockcroft- Gault equation
• Patients in the opinion of the investigator that are unlikley to be able to follow study instructions
• Any subject unable to take antiretroviral medication for whatever reason
• Any subject taking a treatment or medication that is contraindicated when co-administered with any arm or drug in the treatment

Sponsors & Collaborators

• Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba: lead

Study Sites (30)

Hopital Zobda Quitman

Fort de France, Martinique, 97261, France

Location

Centre Hospitalier D'Argenteuil

Argenteuil, 95107, France

Location

Hopital Saint-Jacques

Besançon, 25000, France

Location

Hopital Avicenne

Bobigny, 93000, France

Location

Hopital Jean Verdier

Bondy, 93143, France

Location

Hopital Saint-Andre

Bordeaux, 33075, France

Location

Chu Cote de Nacre

Caen, 14033, France

Location

Hopital Louis Mourier

Colombes, 92700, France

Location

Hopital Le Bocage

Dijon, 21034, France

Location

Hopital Raymond Poincare

Garches, 92380, France

Location

C.H.D de Vendee

La Roche-sur-Yon, 85925, France

Location

Hopital Dupuytren

Limoges, 87000, France

Location

Hopital Sainte-Marguerite

Marseille, 13274, France

Location

Centre Hospitalier de Melun

Melun, 77011, France

Location

Hopital L'Archet

Nice, 06202, France

Location

Hopital Lariboisiere

Paris, 75010, France

Location

Hopital Saint Antoine

Paris, 75012, France

Location

Hopital Pitie-Salpetriere

Paris, 75013, France

Location

Hopital Necker

Paris, 75015, France

Location

Hopital Bichat

Paris, 75018, France

Location

Hopital Tenon

Paris, 75020, France

Location

Hopital Pitie-Salpetriere

Paris, 75651, France

Location

Hopital Cochin

Paris, 75674, France

Location

Hopital Europeen Georges Pompidou

Paris, 75908, France

Location

Hopital Saint-Jean Roussillon

Perpignan, 66046, France

Location

Hopital Rene Dubos

Pontoise, 95303, France

Location

C.H.R.A

Pringy, 74374, France

Location

Hopital Civil

Strasbourg, 67000, France

Location

Hopital Gustave Dron

Tourcoing, 59208, France

Location

Hopital Bretonneau

Tours, 37044, France

Location

Related Publications (1)

• Slama L, Landman R, Assoumou L, Benalycherif A, Samri A, Joly V, Pialoux G, Valin N, Cabie A, Duvivier C, Lambert-Niclot S, Marcelin AG, Peytavin G, Costagliola D, Girard PM; IMEA 040 DATA Study Group. Efficacy and safety of once-daily ritonavir-boosted atazanavir or darunavir in combination with a dual nucleos(t)ide analogue backbone in HIV-1-infected combined ART (cART)-naive patients with severe immunosuppression: a 48 week, non-comparative, randomized, multicentre trial (IMEA 040 DATA trial). J Antimicrob Chemother. 2016 Aug;71(8):2252-61. doi: 10.1093/jac/dkw103. Epub 2016 Apr 10.

  PMID: 27068399 DERIVED

MeSH Terms

Interventions

Darunavir; Atazanavir Sulfate

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Carbamates; Acids, Acyclic; Carboxylic Acids; Sulfones; Sulfur Compounds; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyridines; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Laurence LS SLAMA, PhD

  Hospital TENON

  PRINCIPAL INVESTIGATOR

• Roland RL LANDMAN, PhD

  Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2013
• First Posted: August 26, 2013
• Study Start: February 23, 2011
• Primary Completion: March 29, 2011
• Study Completion: January 7, 2013
• Last Updated: January 12, 2018

Record last verified: 2018-01

Locations

FR (30)