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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00528060

Acronym

ANRS134COPHAR3

Enrollment

Registered

2007-09-11

Start date

2008-01-31

Completion date

2008-11-30

Last updated

2011-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

HIV infections, atazanavir, Pharmacokinetics, Treatment Naive

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.

Interventions

DRUGAtazanavir

2pills/day

DRUGRitonavir

1 pill/day

DRUGTenofovir/emtricitabine

1 pill/day

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
pharmacokinetic parameters of atazanavir (ATV) when combined with ritonavir (RTV) and tenofovir/emtricitabine	week 4

Secondary

Measure	Time frame
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026