Efficacy and Tolerability of an Antiretroviral Bi-Therapy in HIV Infected Patients With Multidrug Resistance
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ClinicalTrials.gov Identifier: NCT00120783 |
Recruitment Status
:
Terminated
First Posted
: July 19, 2005
Last Update Posted
: January 18, 2007
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Indinavir Drug: Lamivudine Drug: Ritonavir | Phase 2 |
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 preclude future therapeutic options. In contrast, treatment interruption provokes the reemergence of wild-type virus with full replicative and pathogenic capacity. The researchers investigated whether a calibrated reduction in drug pressure could stabilize the evolution and the pathogenic potential of resistant virus.
A prospective pilot study was conducted in patients receiving protease inhibitor-based HAART with a resistance genotype predicting less than two active drugs according to the 2002 ANRS algorithm, CD4 counts over or equal to 100/mm3 and plasma HIV RNA below or equal to 5 log/ml. The treatment was low-dose IDV/RTV (200/100 BID) and 3TC 150mg BID. IDV doses were adjusted at week 4 to ensure a Cmin of 250+/-100ng/ml, which, based on a panel of multi-PI resistant viruses, was calculated to yield an inhibitory quotient (Cmin/IC50) of 0.50. Primary end-points were over 25% decrease in CD4 counts (immunological failure–IF), or over 0.7 log increase in plasma HIV RNA (virological failure–VF) at two consecutive monthly visits during the 24-week study. Inclusions were to stop when the total number of failures (VF+IF) reached 7
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 40 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Efficacy and Tolerability of an Antiretroviral bi-Therapy in HIV-1 Infected Patients With Multidrug Resistant HIV ANRS 109 Vista Trial. |
Study Start Date : | February 2002 |
Study Completion Date : | August 2003 |

- 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
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00120783
France | |
Service de Medecine Interne hopital Avicenne | |
Bobigny, France, 93009 cedex |
Principal Investigator: | Odile Launay, MD | Hopital Avicenne,Bobigny, Service de Médecine Interne | |
Study Chair: | Dominique Costagliola | Inserm U720 |
ClinicalTrials.gov Identifier: | NCT00120783 History of Changes |
Other Study ID Numbers: |
ANRS 109 VISTA |
First Posted: | July 19, 2005 Key Record Dates |
Last Update Posted: | January 18, 2007 |
Last Verified: | January 2007 |
Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
Treatment Failure HIV infections |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Ritonavir Indinavir Lamivudine |
HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors |