Efficacy and Tolerability of an Antiretroviral Bi-Therapy in HIV Infected Patients With Multidrug Resistance

• Status: Terminated
• Trial end date: 2003-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This study investigated whether a calibrated reduction in antiretroviral drug pressures could stabilize the evolution and the pathogenic potential of resistant HIV viruses.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis
• Treatments: Indinavir; Lamivudine; Ritonavir

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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