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

Tracking Information
First Submitted Date ICMJE	July 12, 2005
First Posted Date ICMJE	July 19, 2005
Last Update Posted Date	January 18, 2007
Study Start Date ICMJE	February 2002
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE; (submitted: July 18, 2005)	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
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00120783 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: July 18, 2005)	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
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Efficacy and Tolerability of an Antiretroviral Bi-Therapy in HIV Infected Patients With Multidrug Resistance
Official Title ICMJE	Efficacy and Tolerability of an Antiretroviral bi-Therapy in HIV-1 Infected Patients With Multidrug Resistant HIV ANRS 109 Vista Trial.
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 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 ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	HIV Infections
Intervention ICMJE	Drug: Indinavir; Drug: Lamivudine; Drug: Ritonavir
Study Arms	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Terminated
Enrollment ICMJE; (submitted: July 18, 2005)	40
Original Enrollment ICMJE	Same as current
Study Completion Date	August 2003
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	France
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00120783
Other Study ID Numbers ICMJE	ANRS 109 VISTA
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor ICMJE	French National Agency for Research on AIDS and Viral Hepatitis
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Odile Launay, MD Hopital Avicenne,Bobigny, Service de Médecine Interne Study Chair: Dominique Costagliola Inserm U720
PRS Account	French National Agency for Research on AIDS and Viral Hepatitis
Verification Date	January 2007
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP