Measure of Pharmacokinetic Parameters and Adherence With MEMS in Naive HIV Infected Patients Treated With Reyataz Once Daily Combined With Norvir and Truvada
ANRS134COPHAR3
Pilot Study to Measure Exposure to Atazanavir, as a Component of Pharmacokinetic Parameters and Adherence Measured With MEMS in Naive HIV-infected Patients Treated Once Daily With Atazanavir Combined to Ritonavir and to Tenofovir/Emtricitabine. ANRS 134 Cophar 3
1 other identifier
interventional
35
1 country
2
Brief Summary
the trial assessed the pharmacokinetics and long term plasma exposure of the following antiretrovirals: atazanavir when combined to ritonavir and the tenofovir/emtricitabine fixed-dose combination. All drugs will be delivered in MEMS electronic device to monitor dosing history.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 hiv-infections
Started Jan 2008
Shorter than P25 for phase_2 hiv-infections
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 10, 2007
CompletedFirst Posted
Study publicly available on registry
September 11, 2007
CompletedStudy Start
First participant enrolled
January 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedDecember 22, 2011
December 1, 2011
10 months
September 10, 2007
December 21, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
pharmacokinetic parameters of atazanavir (ATV) when combined with ritonavir (RTV) and tenofovir/emtricitabine
week 4
Secondary Outcomes (1)
pharmacokinetics of emtricitabine and tenofovir; intraindividual variability in ARVs concentrations; adherence measured with MEMS records and validated ANRS observance autoquestionnaire; relationships between virological response or side event occurrence
Week 24
Interventions
Eligibility Criteria
You may qualify if:
- Naïve of treatment HIV -1 infected patients
- CD4 above 100/mm3
You may not qualify if:
- pregnancy
- renal failure
- hepatitic disease
- ongoing opportunistic disease
- Hb under 8g/dl; platelets under 50 000/mm3; neutrophils under 750/mm3; Prothrombin index under 80%, Ca or Ph \> 2.5 N
- drugs interacting with investigational drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- French National Agency for Research on AIDS and Viral Hepatitislead
- Bristol-Myers Squibbcollaborator
- Gilead Sciencescollaborator
Study Sites (2)
Hopital du Kremlin Bicêtre Service de médecine interne
Kremlin Bicëtre, 94275, France
Hopital Bichat CIC
Paris, 75877, France
Related Publications (1)
Parienti JJ, Barrail-Tran A, Duval X, Nembot G, Descamps D, Vigan M, Vrijens B, Panhard X, Taburet AM, Mentre F, Goujard C. Adherence profiles and therapeutic responses of treatment-naive HIV-infected patients starting boosted atazanavir-based therapy in the ANRS 134-COPHAR 3 trial. Antimicrob Agents Chemother. 2013 May;57(5):2265-71. doi: 10.1128/AAC.02605-12. Epub 2013 Mar 4.
PMID: 23459496DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cécile Goujard, MD
AP-HP Kremlin-Bicetre
- STUDY DIRECTOR
France Mentre, PHD
AP-HP Bichat, Inserm U738
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2007
First Posted
September 11, 2007
Study Start
January 1, 2008
Primary Completion
November 1, 2008
Study Completion
November 1, 2008
Last Updated
December 22, 2011
Record last verified: 2011-12