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

HIV Infections Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00528060
• Other study ID #: 2007-003203-12
• Status: Completed
• Phase: Phase 2
• First received: September 10, 2007
• Last updated: December 21, 2011
• Start date: January 2008
• Est. completion date: November 2008

Study information

• Verified date: December 2011
• Source: French National Agency for Research on AIDS and Viral Hepatitis
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Atazanavir
2pills/day
• Ritonavir
1 pill/day
• Tenofovir/emtricitabine
1 pill/day

Locations

Country	Name	City	State
France	Hopital du Kremlin Bicêtre Service de médecine interne	Kremlin Bicëtre
France	Hopital Bichat CIC	Paris cedex 18

Sponsors (3)

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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pharmacokinetic parameters of atazanavir (ATV) when combined with ritonavir (RTV) and tenofovir/emtricitabine		week 4	No
Secondary	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	Yes