Clinical Trials

MainTitle

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

This study has been completed
Sponsor
French National Agency for Research on AIDS and Viral Hepatitis

Collaborator
Bristol-Myers Squibb
Gilead Sciences

Information provided by (Responsible Party)
French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier
NCT00528060

First received: September 10, 2007
Last updated: December 21, 2011
Last Verified: December 2011
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
HIV Infections

Drug : Atazanavir
Drug : Ritonavir
Drug : Tenofovir/emtricitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:

Primary Outcome Measures

  • pharmacokinetic parameters of atazanavir (ATV) when combined with ritonavir (RTV) and tenofovir/emtricitabine [ Time Frame: week 4 ]
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 [ Time Frame: Week 24 ]

Enrollment: 35
Study Start Date: January 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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

contacts and locations

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: NCT00528060

Locations

France
Hopital du Kremlin Bicêtre Service de médecine interne
Kremlin Bicëtre, France, 94275
Hopital Bichat CIC
Paris cedex 18, France, 75877

Sponsors and Collaborators

French National Agency for Research on AIDS and Viral Hepatitis
Bristol-Myers Squibb
Gilead Sciences

Investigators

Principal Investigator: Cécile Goujard, MD AP-HP Kremlin-Bicetre
Study Director: France Mentre, PHD AP-HP Bichat, Inserm U738
More Information

More Information


Responsible Party: French National Agency for Research on AIDS and Viral Hepatitis  
ClinicalTrials.gov Identifier: NCT00528060   History of Changes  
Other Study ID Numbers: 2007-003203-12  
Study First Received: September 10, 2007  
Last Updated: December 21, 2011  

Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:

HIV infections
atazanavir
Pharmacokinetics
Treatment Naive

Additional relevant MeSH terms:
HIV Infections
Ritonavir
Atazanavir Sulfate
Tenofovir
Emtricitabine

ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.