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

F

French National Agency for Research on AIDS and Viral Hepatitis

Status

Terminated

Conditions

HIV Infections

Treatments

Drug: nelfinavir
Drug: lopinavir/r
Drug: indinavir
Drug: ritonavir

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00122590
ANRS111 COPHAR 2

Details and patient eligibility

About

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.

Full 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 tolerance of PI-containing HAART. The objective of the Cophar2 trial is to evaluate the feasibility and the impact of an early therapeutic drug monitoring in PI-naive HIV-1 infected patients in order to warrant virological success and safety of HAART.

It is a prospective, open, multicenter trial with repeated early TDM (weeks 2, 8 or 16, 24) after the initiation of HAART including either indinavir/r (IDV), lopinavir/r (LPV) or the new 625 mg formulation of nelfinavir (NFV) bid. It was planned to include 99 PI-naïve HIV-1 infected patients over 18 years old, 33 for each PI. Concentrations were measured by HPLC in each center. If trough concentrations were out of the range of 150-500, 2500-7000 or 1500-5500 ng/ml for IDV, LPV and NFV respectively, the PI doses were adjusted possibly more than once during the first 24 weeks of follow-up. Adjustments were done by steps of one pill (200, 133/33 or 250 mg for IDV, LPV/r or NFV, respectively) bid. Failure of the strategy was defined by either two consecutive viral loads over 200 copies/ml between weeks 16 and 48, or a validated PI-related adverse event grade III or IV or a grade II diarrhoea or renal lithiasis. Patients without adverse events before week 16 were defined as assessable if they had at least the virological assessment of week 16.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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