Status:
TERMINATED
Efficacy and Tolerability of an Antiretroviral Bi-Therapy in HIV Infected Patients With Multidrug Resistance
Lead Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study investigated whether a calibrated reduction in antiretroviral drug pressures could stabilize the evolution and the pathogenic potential of resistant HIV viruses.
Detailed Description
In patients with HIV multidrug resistance, maintaining a failing full-dose HAART regimen usually results in significant drug toxicity and in continued accumulation of resistance mutations that can pre...
Eligibility Criteria
Inclusion
- HIV-1 infection confirmed by Western Blot
- Karnofsky score over or equal to 70
- CD4 over or equal to 200/mm3
- Plasma viral RNA over or equal to 10 000 copies/ml and below 100 000 copies/ml.
- Stability of plasma viral load and CD4-during the last 3 months
- failure of two antiretroviral regimens with 2 PI and one NNRTI
- New efficacy drug on genotype not available
- Treatment on hand with 3 antiretroviral drugs with one PI since 3 months.
- Written inform consent
- Pregnancy
Exclusion
- Hemoglobin below 8g/dL
- Neutrophils below 750/mm3
- ASAT, ALAT over 5N
- Hepatic insufficiency (prothrombin below 50%)
- Acute opportunistic infection
- Immunotherapy
- Treatment with active antiretroviral regimen
- Treatment with enzyme inductor
Key Trial Info
Start Date :
February 1 2002
Trial Type :
INTERVENTIONAL
End Date :
August 1 2003
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00120783
Start Date
February 1 2002
End Date
August 1 2003
Last Update
January 18 2007
Active Locations (1)
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1
Service de Medecine Interne hopital Avicenne
Bobigny, France, 93009 cedex