Evaluation of the Efficacy and Safety Between Two Antiretroviral Regimens, in HIV-1-infected Treatment-naïve Subjects With Low CD4 Counts (DATA)
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| ClinicalTrials.gov Identifier: NCT01928407 |
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Recruitment Status
:
Completed
First Posted
: August 26, 2013
Last Update Posted
: January 12, 2018
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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
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV-1 Infection Immunosuppression-related Infectious Disease | Drug: DARUNAVIR Drug: ATAZANAVIR | Phase 4 |
Show Detailed Description
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 120 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (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. |
| Actual Study Start Date : | February 23, 2011 |
| Actual Primary Completion Date : | March 29, 2011 |
| Actual Study Completion Date : | January 7, 2013 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
| Arm | Intervention/treatment |
|---|---|
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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
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Drug: ATAZANAVIR
The patient included will receive their first antiretroviral regimen included the atazanavir treatment in combination with 2 others molecules
Other Name: REYATAZ
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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
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Drug: DARUNAVIR
The patient included will receive their first antiretroviral regimen included the darunavir treatment in combination with 2 others molecules
Other Name: Prezista
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Primary Outcome Measures
:
- Viral load of HIV-1 < 50 cp/ml [ Time Frame: 48 weeks ]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 ]• 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 ]• 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 ]• 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 ]• 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 ]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 ]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 ]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 ]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 ]• Change from baseline in fasting lipids, fasting glucose and insulin over time in the 2 arms
- Clinic and biologic tolerance [ Time Frame: W48 ]
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 ]• Compare sexual behaviour between the regimens (substudy with a questionnary)
- Adherence patient satisfaction [ Time Frame: W2,W24 et W48 ]• Compare adherence patient satisfaction between the regimens (with questionnary)
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01928407
Locations
| France | |
| Hopital Zobda Quitman | |
| Fort De France, Martinique, France, 97261 | |
| Centre Hospitalier D'Argenteuil | |
| Argenteuil, France, 95107 | |
| Hopital Saint-Jacques | |
| Besancon, France, 25000 | |
| Hopital Avicenne | |
| Bobigny, France, 93000 | |
| Hopital Jean Verdier | |
| Bondy, France, 93143 | |
| Hopital Saint-Andre | |
| Bordeaux, France, 33075 | |
| Chu Cote de Nacre | |
| Caen, France, 14033 | |
| Hopital Louis Mourier | |
| Colombes, France, 92700 | |
| Hopital Le Bocage | |
| Dijon, France, 21034 | |
| Hopital Raymond Poincare | |
| Garches, France, 92380 | |
| C.H.D de Vendee | |
| La Roche Sur Yon, France, 85925 | |
| Hopital Dupuytren | |
| Limoges, France, 87000 | |
| Hopital Sainte-Marguerite | |
| Marseille, France, 13274 | |
| Centre Hospitalier de Melun | |
| Melun, France, 77011 | |
| Hopital L'Archet | |
| Nice, France, 06202 | |
| Hopital Lariboisiere | |
| Paris, France, 75010 | |
| Hopital Saint Antoine | |
| Paris, France, 75012 | |
| Hopital Pitie-Salpetriere | |
| Paris, France, 75013 | |
| Hopital Necker | |
| Paris, France, 75015 | |
| Hopital Bichat | |
| Paris, France, 75018 | |
| Hopital Tenon | |
| Paris, France, 75020 | |
| Hopital Pitie-Salpetriere | |
| Paris, France, 75651 | |
| Hopital Cochin | |
| Paris, France, 75674 | |
| Hopital Europeen Georges Pompidou | |
| Paris, France, 75908 | |
| Hopital Saint-Jean Roussillon | |
| Perpignan, France, 66046 | |
| Hopital Rene Dubos | |
| Pontoise, France, 95303 | |
| C.H.R.A | |
| Pringy, France, 74374 | |
| Hopital Civil | |
| Strasbourg, France, 67000 | |
| Hopital Gustave Dron | |
| Tourcoing, France, 59208 | |
| Hopital Bretonneau | |
| Tours, France, 37044 | |
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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
| First Posted: | August 26, 2013 Key Record Dates |
| Last Update Posted: | January 12, 2018 |
| Last Verified: | January 2018 |
Keywords provided by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba:
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naives, CD4 < 200 cell/mm3, Atazanavir, Darunavir |
Additional relevant MeSH terms:
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Communicable Diseases Infection Darunavir Atazanavir Sulfate HIV Protease Inhibitors Protease Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |