search
Back to results

Measure of Pharmacokinetic Parameters and Adherence With MEMS in Naive HIV Infected Patients Treated With Reyataz Once Daily Combined With Norvir and Truvada (ANRS134COPHAR3)

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Atazanavir
Ritonavir
Tenofovir/emtricitabine
Sponsored by
French National Agency for Research on AIDS and Viral Hepatitis
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV infections, atazanavir, Pharmacokinetics, Treatment Naive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Naïve of treatment HIV -1 infected patients
  • CD4 above 100/mm3

Exclusion Criteria:

  • 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

Sites / Locations

  • Hopital du Kremlin Bicêtre Service de médecine interne
  • Hopital Bichat CIC

Outcomes

Primary Outcome Measures

pharmacokinetic parameters of atazanavir (ATV) when combined with ritonavir (RTV) and tenofovir/emtricitabine

Secondary Outcome Measures

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

Full Information

First Posted
September 10, 2007
Last Updated
December 21, 2011
Sponsor
French National Agency for Research on AIDS and Viral Hepatitis
Collaborators
Bristol-Myers Squibb, Gilead Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT00528060
Brief Title
Measure of Pharmacokinetic Parameters and Adherence With MEMS in Naive HIV Infected Patients Treated With Reyataz Once Daily Combined With Norvir and Truvada
Acronym
ANRS134COPHAR3
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
French National Agency for Research on AIDS and Viral Hepatitis
Collaborators
Bristol-Myers Squibb, Gilead Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The trial is a phase II, open label, non-randomized, prospective multicenter trial to assess 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV infections, atazanavir, Pharmacokinetics, Treatment Naive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Atazanavir
Intervention Description
2pills/day
Intervention Type
Drug
Intervention Name(s)
Ritonavir
Intervention Description
1 pill/day
Intervention Type
Drug
Intervention Name(s)
Tenofovir/emtricitabine
Intervention Description
1 pill/day
Primary Outcome Measure Information:
Title
pharmacokinetic parameters of atazanavir (ATV) when combined with ritonavir (RTV) and tenofovir/emtricitabine
Time Frame
week 4
Secondary Outcome Measure Information:
Title
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
Time Frame
Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Naïve of treatment HIV -1 infected patients CD4 above 100/mm3 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cécile Goujard, MD
Organizational Affiliation
AP-HP Kremlin-Bicetre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
France Mentre, PHD
Organizational Affiliation
AP-HP Bichat, Inserm U738
Official's Role
Study Director
Facility Information:
Facility Name
Hopital du Kremlin Bicêtre Service de médecine interne
City
Kremlin Bicëtre
ZIP/Postal Code
94275
Country
France
Facility Name
Hopital Bichat CIC
City
Paris cedex 18
ZIP/Postal Code
75877
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
23459496
Citation
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.
Results Reference
derived

Learn more about this trial

Measure of Pharmacokinetic Parameters and Adherence With MEMS in Naive HIV Infected Patients Treated With Reyataz Once Daily Combined With Norvir and Truvada

We'll reach out to this number within 24 hrs