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

Information source: French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections

Intervention: Atazanavir (Drug); Ritonavir (Drug); Tenofovir/emtricitabine (Drug)

Phase: Phase 2

Status: Completed

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

Official(s) and/or principal investigator(s):
Cécile Goujard, MD, Principal Investigator, Affiliation: AP-HP Kremlin-Bicetre
France Mentre, PHD, Study Director, Affiliation: AP-HP Bichat, Inserm U738

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.

Clinical Details

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

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

Secondary outcome: 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

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Hopital du Kremlin Bicêtre Service de médecine interne, Kremlin Bicëtre 94275, France

Hopital Bichat CIC, Paris cedex 18 75877, France

Additional Information

Starting date: January 2008
Last updated: December 21, 2011

Page last updated: August 23, 2015

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