Evaluation of the Efficacy and Safety Between Two Antiretroviral Regimens, in HIV-1-infected Treatment-naïve Subjects With Low CD4 Counts (DATA)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified August 2013 by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Sponsor:
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Information provided by (Responsible Party):
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
ClinicalTrials.gov Identifier:
NCT01928407
First received: June 19, 2013
Last updated: August 20, 2013
Last verified: August 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV-1 Infection Immunosuppression-related Infectious Disease |
Drug: DARUNAVIR Drug: ATAZANAVIR |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase IV, Prospective, Multicenter , Randomized Open Label, 48 Weeks Study to Evaluate the Antiretroviral Efficacy and Safety of Atazanavir or Darunavir,Each in Combination With a Fixed Dose of Tenofovir Emtricitabine in HIV-1-infected Treatment-naïve Subjects With CD4counts Below 200 µL. |
Resource links provided by NLM:
Further study details as provided by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba:
Primary Outcome Measures:
- Viral load of HIV-1 < 50 cp/ml [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]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
Secondary Outcome Measures:
- • Proportion of subjets with virologic efficacy [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]• Proportion of subjets with virologic efficacy (viral load of HIV-1 <50 cp/ml)
- • Proportion of subjects with confirmed virologic failure [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]• Proportion of subjects with confirmed virologic failure (viral load > 50 cp/ml on 2 consecutive mesures)
- Viral lod of HIV-1 on seminal fluid [ Time Frame: W00,W4 et W48 ] [ Designated as safety issue: Yes ]• Evaluate the viral load of HIV-1 at week 0, week 4 and week 48 on the seminal fluid (substudy)
- Immunologic response [ Time Frame: W-4,W2,W4,W12,W24 and W48 ] [ Designated as safety issue: Yes ]• Evaluate the immunologic response by the CD4 mesearement at W-4,W2,W4,W12,W24 and W48
- Differenciation and activation of lymphocytes [ Time Frame: W0,W2,W4,W12,W24 and W48 ] [ Designated as safety issue: Yes ]At the end of the study, in a central lab, we will measure some inflammation and activation markers (CD69, HLA-DR, CD38, annexine V, IL-6, CD14s, IL-7 plasma) of lymphocytes CD4 and CD8(with the plasmatheque collected during the study)
- Pharmacokinetics evaluation of the drugs in plasma [ Time Frame: W4,W24 and W48 ] [ Designated as safety issue: Yes ]Measure of drugs (atazanir and darunavir) concentration (24 hours after taking treatment)in plasma at week 4, 24, and 48
- Pharmacokinetic evaluation of the drugs in semen [ Time Frame: W4 and W48 ] [ Designated as safety issue: Yes ]Measure of drugs (atazanir and darunavir) concentration (24 hours after taking treatment)in semen at week 4 and 48
- • Evaluate the relationship of bilirubinemia with atazanavir [ Time Frame: W4 and W48 ] [ Designated as safety issue: Yes ]Evaluate the relationship of the evolution of the measure of bilirubinemia (collected during study) with the concentration of atazanavir in blood
- Fasting glucose, lipids and insulin [ Time Frame: W48 ] [ Designated as safety issue: Yes ]• Change from baseline in fasting lipids, fasting glucose and insulin over time in the 2 arms
- Clinic and biologic tolerance [ Time Frame: W48 ] [ Designated as safety issue: Yes ]
Evaluate the clinic and biologic tolerance between the 2 regimens (adverse event and some biologic measure will be collected for this evaluation).
We will see in two arms if there are more adverse event or biological event.
- Sexual behaviour [ Time Frame: W0,W24 et W48 ] [ Designated as safety issue: Yes ]• Compare sexual behaviour between the regimens (substudy with a questionnary)
- Adherence patient satisfaction [ Time Frame: W2,W24 et W48 ] [ Designated as safety issue: No ]• Compare adherence patient satisfaction between the regimens (with questionnary)
| Estimated Enrollment: | 120 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: ATAZANAVIR
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
The patient included will receive their first antiretroviral regimen included the atazanavir treatment in combination with 2 others molecules
Other Name: REYATAZ
|
|
Experimental: DARUNAVIR
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
The patient included will receive their first antiretroviral regimen included the darunavir treatment in combination with 2 others molecules
Other Name: Prezista
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01928407
Please refer to this study by its ClinicalTrials.gov identifier: NCT01928407
Contacts
| Contact: Aïda AB BENALYCHERIF | +33.1.40.25.63.65 | aida.benalycherif@gmail.com | |
| Contact: Karine KA AMAT | +33.1.40.25.63.52 | karine.amat@hotmail.fr |
Locations
| France | |
| Hopital Zobda Quitman | Recruiting |
| Fort-de-france, Martinique, France, 97261 | |
| Contact: André AC CABIE, PhD +33.5.96.55.23.01 andre.cabie@chu-fort-de-france.fr | |
| Principal Investigator: André AC CABIE, PhD | |
| Centre Hospitalier D'Argenteuil | Recruiting |
| Argenteuil, France, 95107 | |
| Contact: Juliette JG GERBE +33.1.34.23.22.18 juliette.gerbe@ch-argenteuil.fr | |
| Principal Investigator: Virginie VM MASSE, PhD | |
| Hopital Saint-Jacques | Recruiting |
| Besancon, France, 25000 | |
| Contact: Véronique VB BOURDEAUX, PhD +33.3.81.21.85.33 c1bourdeaux@chu-besancon.fr | |
| Principal Investigator: Bruno BH HOEN, PhD | |
| Hopital Avicenne | Recruiting |
| Bobigny, France, 93000 | |
| Contact: Gaëlle GO OBENGA, PhD +33.1.48.95.54.21 gaelle.obenga@avc.aphp.fr | |
| Principal Investigator: Olivier OB BOUCHAUD, PhD | |
| Hopital Jean Verdier | Recruiting |
| Bondy, France, 93143 | |
| Contact: Mufide MK KAHRAMAN +33.1.48.02.63.11 mufide.kahraman@jvr.aphp.fr | |
| Principal Investigator: Vincent VJ JEANTILS, PhD | |
| Hopital Saint-Andre | Recruiting |
| Bordeaux, France, 33075 | |
| Contact: Sabrina SC CALDATO +33.5.56.79.57.33 sabrina.caldato@chu-bordeaux.fr | |
| Principal Investigator: Patrick PM MERCIE, PhD | |
| Chu Cote de Nacre | Recruiting |
| Caen, France, 14033 | |
| Contact: Philippe PF FERET +33.2.31.06.50.87 feret-p@chu-caen.fr | |
| Principal Investigator: Renaud RV VERDON, PhD | |
| Hopital Louis Mourier | Recruiting |
| Colombes, France, 92700 | |
| Contact: Feng FZ ZENG +33.1.47.60.61.84 feng.zeng@lmr.aphp.fr | |
| Principal Investigator: Emmanuel EM MORTIER, PhD | |
| Hopital Le Bocage | Recruiting |
| Dijon, France, 21034 | |
| Contact: Sandrine ST GOHIER +33.3.80.29.36.31 sandrine.gohier@chu-dijon.fr | |
| Principal Investigator: Lionel LP PIROTH, PhD | |
| Hopital Raymond Poincare | Recruiting |
| Garches, France, 92380 | |
| Contact: Huguette HB BERTHE +33.1.47.10.46.65 huguette.berthe@rpc.aphp.fr | |
| Principal Investigator: Pierre PT DE TRUCHIS, PhD | |
| C.H.D de Vendee | Recruiting |
| La Roche Sur Yon, France, 85925 | |
| Contact: Isabelle IS SUAUD +33.2.51.37.49.66 hjmpu@chd-vendee.fr | |
| Principal Investigator: Philippe PP PERRE, PhD | |
| Hopital Dupuytren | Recruiting |
| Limoges, France, 87000 | |
| Contact: Claire CG GENET, PhD +33.5.55.05.66.44 claire.genet@unilim.fr | |
| Principal Investigator: Claire CG GENET, PhD | |
| Hopital Sainte-Marguerite | Recruiting |
| Marseille, France, 13274 | |
| Contact: Alena AI IVANOVA +33.4.91.74.61.63 alena.ivanova@mail.ap-hm.fr | |
| Principal Investigator: Isabelle IM POIZOT-MARTIN, PhD | |
| Centre Hospitalier de Melun | Recruiting |
| Melun, France, 77011 | |
| Contact: Ali AK KARA, PhD +33.1.64.71.60.96 ali.kara@ch-melun.fr | |
| Principal Investigator: Ali AK KARA, PhD | |
| Hopital L'Archet | Recruiting |
| Nice, France, 06202 | |
| Contact: Marie-Ange MS SERINI +33.4.92.03.90.22 serini.ma@chu-nice.fr | |
| Principal Investigator: Jacques JD DURANT, PhD | |
| Hopital Bichat | Recruiting |
| Paris, France, 75018 | |
| Contact: Zélie ZJ JULIA +33.1.40.25.70.57 zelie.julia@bch.aphp.fr | |
| Principal Investigator: Véronique VJ JOLY, PhD | |
| Hopital Cochin | Recruiting |
| Paris, France, 75674 | |
| Contact: Marie-Pierre MP PIETRI +33.1.58.41.21.34 marie-pierre.pietri@cch.aphp.fr | |
| Principal Investigator: Dominique DS SALMON, PhD | |
| Hopital Europeen Georges Pompidou | Recruiting |
| Paris, France, 75908 | |
| Contact: Erika EB BOURZAM +33.1.56.09.33.03 erika.bourzam@egp.aphp.fr | |
| Principal Investigator: Laurence LW WEISS, PhD | |
| Hopital Lariboisiere | Recruiting |
| Paris, France, 75010 | |
| Contact: Maguy MP PARRINELLO +33.1.49.95.63.43 maguy.parrinello@lrb.aphp.fr | |
| Principal Investigator: Jean-François JB BERGMANN, PhD | |
| Hopital Necker | Recruiting |
| Paris, France, 75015 | |
| Contact: Fatima FT TOUAM +33.1.44.49.40.28 fatima.touam@nck.aphp.fr | |
| Principal Investigator: Claudine CD DUVIVIER, PhD | |
| Hopital Pitie-Salpetriere | Recruiting |
| Paris, France, 75651 | |
| Contact: Catherine CL LUPIN +33.1.42.16.10.95 catherine.lupin@psl.aphp.fr | |
| Principal Investigator: Anne AS SIMON, PhD | |
| Hopital Pitie-Salpetriere | Recruiting |
| Paris, France, 75013 | |
| Contact: Patricia PB BOURSE +33.1.42.16.02.93 patricia.bourse@psl.aphp.fr | |
| Principal Investigator: Christine CK KATLAMA, PhD | |
| Hopital Saint Antoine | Recruiting |
| Paris, France, 75012 | |
| Contact: Jean-Luc JL LAGNEAU +33.1.49.28.24.86 jean-luc.lagneau@sat.aphp.fr | |
| Principal Investigator: Nadia NV VALIN, PhD | |
| Hopital Tenon | Recruiting |
| Paris, France, 75020 | |
| Contact: Laurence LS SLAMA, PhD +33.1.56.01.74.36 laurence.slama@tnn.aphp.fr | |
| Contact: Nadège NV VELAZQUEZ +33.1.56.01.74.36 nadege.velazquez@tnn.aphp.fr | |
| Principal Investigator: Laurence LS SLAMA, PhD | |
| Hopital Saint-Jean Roussillon | Recruiting |
| Perpignan, France, 66046 | |
| Contact: Martine MM MALET +33.4.68.61.61.43 recherche.clinique@ch-perpignan.fr | |
| Principal Investigator: Hugues HA AUMAITRE, PhD | |
| Hopital Rene Dubos | Recruiting |
| Pontoise, France, 95303 | |
| Contact: Martine MD DESCHAUD +33.1.30.75.47.24 martine.deschaud@ch-pontoise.fr | |
| Principal Investigator: Laurent LB BLUM, PhD | |
| C.H.R.A | Recruiting |
| Pringy, France, 74374 | |
| Contact: Gaëlle GC CLAVERE +33.4.50.63.67.93 gclavere@ch-annecy.fr | |
| Principal Investigator: Jean-Pierre JB BRU, PhD | |
| Hopital Civil | Recruiting |
| Strasbourg, France, 67000 | |
| Contact: Patricia PF FISCHER +33.3.69.55.05.01 patricia.fischer@chru-strasbourg.fr | |
| Principal Investigator: David DR REY, PhD | |
| Hopital Gustave Dron | Recruiting |
| Tourcoing, France, 59208 | |
| Contact: Sylvie SV VANDAMME svandamme@ch-tourcoing.fr | |
| Principal Investigator: Yazdan YY YAZDANPANAH, PhD | |
| Hopital Bretonneau | Recruiting |
| Tours, France, 37044 | |
| Contact: Gaëlle GF FAJOLE +33.2.47.47.37.14 g.fajole@chu-tours.fr | |
| Principal Investigator: Louis LB BERNARD, PhD | |
Sponsors and Collaborators
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Investigators
| Principal Investigator: | Laurence LS SLAMA, PhD | Hospital TENON | |
| Principal Investigator: | Roland RL LANDMAN, PhD | Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba |
More Information
No publications provided
| Responsible Party: | Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba |
| ClinicalTrials.gov Identifier: | NCT01928407 History of Changes |
| Other Study ID Numbers: | IMEA 040-DATA |
| Study First Received: | June 19, 2013 |
| Last Updated: | August 20, 2013 |
| Health Authority: | France: Agence Nationale de Sécurité du Médicament et des produits de santé |
Keywords provided by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba:
|
naives, CD4 < 200 cell/mm3, Atazanavir, Darunavir |
Additional relevant MeSH terms:
|
Atazanavir Darunavir Anti-HIV Agents Anti-Infective Agents Anti-Retroviral Agents Antiviral Agents |
Enzyme Inhibitors HIV Protease Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protease Inhibitors Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015