Clinical trial NCT00528060: Measure of Pharmacokinetic Parameters and Adherence With MEMS in Naive HIV Infected Patients Treated With Reyataz Once Daily Combined With Norvir and Truvada
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: HIV infections
atazanavir
Pharmacokinetics
Treatment Naive
Lead sponsor: French National Agency for Research on AIDS and Viral Hepatitis
Sponsor class: OTHER_GOV
Collaborators: name: Bristol-Myers Squibb
name: Gilead Sciences
First posted: 2007-09-11
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: pharmacokinetic parameters of atazanavir (ATV) when combined with ritonavir (RTV) and tenofovir/emtricitabine
timeFrame: week 4
Secondary outcomes:
measure: 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
timeFrame: Week 24
Other outcomes:
Locations:
city: Kremlin Bicëtre
country: France
facility: Hopital du Kremlin Bicêtre Service de médecine interne
city: Paris cedex 18
country: France
facility: Hopital Bichat CIC
Study officials:
affiliation: AP-HP Kremlin-Bicetre
name: Cécile Goujard, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AP-HP Bichat, Inserm U738
name: France Mentre, PHD
role: STUDY_DIRECTOR
References:
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.