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

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis
• Collaborators: Bristol-Myers Squibb; Gilead Sciences
• Treatments: Atazanavir Sulfate; Emtricitabine; Ritonavir; Tenofovir

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