Status:
TERMINATED
Evaluation of Therapeutic Drug Monitoring of Protease Inhibitors on Virologic Success and Tolerance of Highly Active Antiretroviral Therapy (HAART)
Lead Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Detailed Description
Because of the large pharmacokinetic inter-patient variability of protease inhibitors (PI), therapeutic drug monitoring (TDM) of protease inhibitor (PI) has been proposed to improve efficacy and toler...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
End Date :
March 1 2005
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT00122590
Start Date
July 1 2002
End Date
March 1 2005
Last Update
August 1 2005
Active Locations (1)
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1
Service de Medecine Interne Hopital Cochin
Paris, France, 75014