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

NCT00120783 | Terminated Phase 2

• 1 other identifier: ANRS 109 VISTA
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

Treatment Failure; HIV infections

Outcome Measures

Primary Outcomes (1)

• Decrease over 25% in CD4 counts (immunological failure-IF), or increase over 0.7 log in plasma HIV RNA (virological failure-VF) at two consecutive monthly visits during the 24-week study

Secondary Outcomes (5)

• Development of an HIV-1-related AIDS defining event

• Death

• Change in CD4 cell count between baseline and week 24

• Change in plasma HIV-RNA level between baseline and week 4, week 8, week 12 and week 24

• Change in genotypic and phenotypic resistance between baseline and week 2

Interventions

Indinavir DRUG

Lamivudine DRUG

Ritonavir DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• French National Agency for Research on AIDS and Viral Hepatitis: lead

Study Sites (1)

Service de Medecine Interne hopital Avicenne

Bobigny, 93009 cedex, France

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Indinavir; Lamivudine; Ritonavir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles

Study Officials

• Odile Launay, MD

  Hopital Avicenne,Bobigny, Service de Médecine Interne

  PRINCIPAL INVESTIGATOR

• Dominique Costagliola

  Inserm U720

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: July 12, 2005
• First Posted: July 19, 2005
• Study Start: February 1, 2002
• Study Completion: August 1, 2003
• Last Updated: January 18, 2007

Record last verified: 2007-01

Locations

FR (1)