NCT00122590

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 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P25-P50 for not_applicable hiv-infections

Timeline
Completed

Started Jul 2002

Typical duration for not_applicable hiv-infections

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 22, 2005

Completed
Last Updated

August 1, 2005

Status Verified

July 1, 2005

First QC Date

July 20, 2005

Last Update Submit

July 29, 2005

Conditions

HIV Infections

Keywords

protease inhibitorsnelfinavirlopinavirindinavirPharmacokinetics

Outcome Measures

Primary Outcomes (2)

  • treatment failure defined as viral load greater than 200 copies/ml between week 16 (W16) and week 48 (W48) (confirmed by 2 samples spiked at least 15 days apart but no more than 45 days after virological failure, assayed by 50 copies/ml method)

  • toxicity related to PI, defined as adverse event grade 3 or 4 with ANRS quotation, renal colic, diarrhoea grade 2, or cholesterolemia over 10 times the normal value

Secondary Outcomes (12)

  • virological failure: viral load over 200 copies/ml between W16 and W48 (confirmed by 2 samples spiked at least 15 days apart but no more than 45 days after virological failure, assayed by 50 copies/ml method)

  • toxicity related to PI: adverse events grade 3 or 4 with ANRS quotation, renal colic, diarrhoea grade 2, or cholesterolemia over 10 times the normal value

  • patients with trough plasma concentrations outside the therapeutic range at W24 and W48

  • concentration changes with dosage variation

  • time to obtain a viral load below 200 copies/ml

  • +7 more secondary outcomes

Interventions

nelfinavirDRUG
lopinavir/rDRUG
indinavirDRUG
ritonavirDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Medecine Interne Hopital Cochin

Paris, 75014, France

Location

MeSH Terms

Conditions

HIV Infections

Interventions

NelfinavirIndinavirRitonavir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

IsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-RingThiazolesSulfur CompoundsOrganic ChemicalsAzoles

Study Officials

  • Dominique Salmon, MD

    Service de Medecine Interne Hopital Cochin Paris

    PRINCIPAL INVESTIGATOR

  • France Mentre, MD

    Inserm EMI 03 57

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

July 20, 2005

First Posted

July 22, 2005

Study Start

July 1, 2002

Study Completion

March 1, 2005

Last Updated

August 1, 2005

Record last verified: 2005-07

Locations

FR(1)