Evaluation of Therapeutic Drug Monitoring of Protease Inhibitors on Virologic Success and Tolerance of Highly Active Antiretroviral Therapy (HAART)

• Status: Terminated
• Trial end date: 2005-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This Cophar2 study is a trial which evaluates repeated early therapeutic drug monitoring, from weeks 2 to 24, after the initiation of HAART including either indinavir/r, lopinavir/r or the new 625 mg formulation of nelfinavir twice-a-day (bid). If trough concentrations were out of the range given for each protease inhibitor (PI), the PI dose was adjusted.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis
• Collaborator: Hoffmann-La Roche
• Treatments: HIV Protease Inhibitors; Indinavir; Lopinavir; Nelfinavir; Protease Inhibitors; Ritonavir

Criteria

Inclusion Criteria:

• Patients infected with HIV-1

• Needing an antiretroviral treatment according to standard of care

• HIV viral load greater than 1000 copies/ml

• Beginning a treatment containing a PI (indinavir with or without ritonavir, nelfinavir, lopinavir + ritonavir) and 2 reverse transcriptase inhibitors

• PI-naive

• Antiretroviral treatment-naive or already treated with reverse transcriptase inhibitors but if the viral genotypic test does not show more than 2 major mutations (including T215Y/F, Q151M, M184V/I, V75M/S, L74V) and if 3 nucleoside analogues are still active except for didanosine.

Exclusion Criteria:

• Pregnant women and nursing mothers

• Acute HIV infection

• Diabetes

• Renal insufficiency with creatinine clearance below 30 ml/min

• Cardiac insufficiency

• Hepatic insufficiency with TP below 60%

• Treatment with known interactions with PI

• Chemotherapy against Kaposi's sarcoma, lymphoma, neoplasia

• Treatment containing interferon (INF) or interleukin-2 (IL2) or HIV- immune vaccine

• Treatment with hypolipemic drugs

• Laxative treatment

• Previous renal colic

• Diarrhoea with more than 5 stools/day since one week